CardioChek
Price: $99.95

• Portable Whole Blood Test System
• Single test capability for both Cholesterol Screening & Diabetes monitoring.
• Easy-to-use; Results in about a minute
• Accurate Results
• Internal result storage and review
• CLIA waived & OTC cleared

CardioChek PA Professional
Price: $550.00

• Easy-to-use with menu operation
• Both single and panel testing capability
• Lipid profile results
  (Total Cholesterol, HDL Cholesterol,Triglycerides - instrument software calculates an LDL Cholesterol result) - all from a single finger stick whole blood sample.
• Accurate Results
• Internal result storage and review
• CLIA waived for professional use

Awarded Popular Science's Best of What's New 2006! - Personal Health category

CardioCheck PA optional thermal printer allows patient test results to be printed out. Measuring 7" long, 3.5" wide, 5.5" high, this handy printer uses very little space -- weighs only 3 pounds. The CardioChek Thermal Printer can print test results with the time and date of the test, or can print previous test results from memory. The printer is capable of printing on 500-count thermal labels or thermal paper rolls.

More than a glucose monitor, more than a cholesterol tester...

The CardioChek home health test kit may reduce your risk from the complications of diabetes and heart disease. Most important is good glycemic control through diet, exercise, blood monitoring and medication. The CardioChek glucose monitor and cholesterol tester is the first and only complete health management product that can perform multiple tests on one device. Color-coded strips and MEMo chips provide easy identification and correct calibration. As new tests become approved, the device is easily upgraded to include new test chemistries.

The CardioChek: 

1. Multiple blood chemistry testing.
2. One-step testing.
3. Average for previous ten tests, past fourteen and thirty day.
4. Storage of up to 250 glucose and 30 of each other test.
5. Automatic shut-off in two minutes from non-use of instrument.
6. Automatic calibration with inserted MEMo chip (included with each strip package).
7. Results in about one minute and future test upgradeable.

With the CardioChek and CardioChek PA you can reduce your risk from the complications of diabetes and heart disease. Most important is good glycemic control through diet, exercise, blood monitoring and medication. Ketone monitoring is also important to monitor for diabetic ketoacidosis from consistently high glucose levels and stressful events.

CardioChek is the first and only complete health management product that can perform multiple tests on one device. Color-coded strips and PTS Panels provide easy identification and correct calibration. As new tests become approved, the device is easily upgraded to include new test chemistries.

CardioChek and CardioChek PA

Easy to Use ... Accurate Results...in 4 easy steps:

	1. Insert MEMo Chip and turn on the instrument.
	2. Insert test strip into instrument.
	3. Apply blood sample using capillary blood collector.
	4. Read results.

With the CardioChek instrument and the PTS PANELS Test Strips, you now have an entire health management system in the palm of your hand. The CardioChek is a hand-held medical diagnostics system that monitors key health indicators, including total cholesterol, HDL cholesterol, and triglycerides, plus blood glucose and ketones - all in the comfort of your own home. The CardioChek blood testing device provides the tools for meeting cholesterol screening and diabetes management guidelines. Only PTS can provide this wide of a range of whole blood testing on a portable, easy to use system, with clinically accurate results.

The system includes a meter instrument as well as test strip. This easy-to-use blood test system displays the results of your blood test in about one minute, with accurate results every time. The CardioChek blood testing device features internal result storage for quick easy review. Unlike other systems that only test ONE specific health indicator - such as cholesterol or blood glucose, the CardioChek meter allows you to test a range of key health indicators. And, because of CardioChek's modular PTS PANELS technology, the device can never become obsolete; it is designed to run new tests as they are developed.

The CardioChek PA gives you additional professional features, such as the Lipid Panel, which allows one to perform several different blood tests simultaneously, with only one drop of blood.

PTS Panels Test Strip Measuring Range

Test all of these blood chemistries with just one instrument:

• Glucose
• Total Cholesterol
• HDL (good) Cholesterol
• Blood Ketone
• Triglycerides

The CardioChek PA medical diagnostic testing system can be classified as durable medical equipment (DME). Associated test strips can be classified as disposable medical equipment. In general, when CardioChek products are covered under major medical, they are considered DME. When covered under pharmacy benefits, they are considered as drugs or disposables.

Metabolic Chemistry Panel

Metabolic Syndrome Chemistry -- Brand New!

1. Estimated 47 million people with metabolic syndrome
2. One in six Americans are at risk

Metabolic syndrome is a cluster of conditions that occur together, increasing your risk for heart disease, stroke and diabetes. Having just one of these conditions — increased blood pressure, elevated insulin levels, excess body fat around the waist or abnormal cholesterol levels — contributes to your risk of serious disease. In combination, your risk is even greater.
Introducing the Metabolic Chemistry Panel.  This new test strip measures: HDL Cholesterol, Triglycerides and Glucose.

The American Heart Association and the National Heart, Lung, and Blood Institute recommend that the metabolic syndrome be identified as the presence of three or more of these components:

• Elevated waist circumference:
  • Men — Equal to or greater than 40 inches (102 cm)
  • Women — Equal to or greater than 35 inches (88 cm)
• Elevated triglycerides:
  • Equal to or greater than 150 mg/dL
• Reduced HDL (“good”) cholesterol:
  • Men — Less than 40 mg/dL
  • Women — Less than 50 mg/dL
• Elevated blood pressure:
  • Equal to or greater than 130/85 mm Hg
• Elevated fasting glucose:
  • Equal to or greater than 100 mg/dL

DEVELOPMENT OF A METABOLIC SYNDROME PANEL TEST STRIP

The reason CardioChek decided to develop this product (Metabolic Syndrome Panel) was quite simple. They had a number of our customers asking: “Do you have a ‘Metabolic Syndrome Panel’ containing glucose, HDL cholesterol and triglycerides?” The most appropriate name was “Metabolic Syndrome Panel”.

There are a huge number of references for metabolic syndrome. Click here sampling of what CardioCheck found regarding Metabolic Syndrome.

Replacement Test Strips and Accessories Only (without the blood testing device)

Glucose Test Strips, 25 ct., $19.95 - Quantity: Total Cholesterol Test Strips, 3 ct., $13.95 - Quantity: Total Cholesterol Test Strips, 6 ct., $21.95 - Quantity: Total Cholesterol Test Strips, 25 ct., $90.48 - Quantity: HDL Cholesterol Test Strips, 6 ct., $21.95 - Quantity: Blood Ketone Test Strips, 25 ct., $92.96 - Quantity: Triglyceride Test Strips, 6 ct., $21.95 - Quantity: Triglyceride Test Strips, 25 ct., $90.79 - Quantity: Pipettes/Blood Collectors, 25 pack, $5 - Quantity: Lancets, 100 pack, $40 - Quantity: Multi Chemistry Control Solution , $43 - Quantity: HDL Control Solution, $27.14 - Quantity:   For use with CardioCheck PA Only: LDL Cholesterol Test Strips, 25 ct., $143.17 - Quantity: Combo Glucose-Cholesterol Test Strips, 25 ct, For CardioChek PA ONLY, $99.50 - Quantity: New! Metabolic Syndrome Panel, Measures HDL, Triglycerides & Glucose, (for use with CardioChek PA only), 15 ct, $114.69 - Quantity: New! Combo Cholesterol, HDL & Glucose Test Strips, (for use with CardioChek PA only), 15 ct, $139.05 - Quantity: Pipettes/Blood Collectors for Lipid Panel, HDL-Cholesterol and Glucose-Cholesterol strips, 40 mcl, 16 pack, $8 - Quantity: Combo Cholesterol-HDL Test Strips (for use with CardioChek PA only -- requires 40 mcl pipettes), 15 ct, $185.33 - Quantity: Lipid Panel, 15 ct., $150.44 (For use with CardioChek PA only) - Quantity: Thermal Printer Labels, 500 ct., $22.66 - Quantity: Thermal Printer Paper, 1 roll, $33.99 - Quantity: PLEASE NOTE: Open, Used or Expired test strips are not returnable. If item is found to be defective by the manufacturer, the item may be exchanged or returned for a refund. Additional Product Information PRODUCT PUBLICATIONS (PDFs) Accuracy of the CardioChek PlA Lipid Panel Test Strips White Paper Lipid Panel Test Strip Product Insert¹ Total Cholesterol Test Strip Product Insert¹ HDL Cholesterol Test Strip Product Insert¹ LDL Cholesterol Test Strip Product Insert¹ Triglycerides Test Strip Product Insert¹ Glucose Test Strip Product Insert¹ Ketone Test Strip Product Insert¹ Multi-Chem Control Product Insert HDL Control Product Insert

What CardioCheck found regarding Metabolic Syndrome.

I. Definitions of “Metabolic Syndrome Panel” published.

1. National Heart, Lung, and Blood Institute, NIH,  National Cholesterol Education Program

National Cholesterol Education Program, High Blood Cholesterol, ATP III Guidelines At-A-Glance, Quick Desk Reference, U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 01-3305, May 2001.

              Clinical Identification of the Metabolic Syndrome - Any 3 of the Following:

2. World Health Organization

Avoiding heart attacks and strokes : don’t be a victim - protect yourself. World Health Organization. ISBN 92 4 154672 7 (NLM classification: WG 300), WHO Press, 2005, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.
 
“When a person has central obesity (too much weight around the waist),
abnormal blood fat levels (e.g. high triglyceride level or low HDL cholesterol;
See section 11), high blood pressure and high blood sugar at the same time,
this is known as metabolic syndrome.”

3. International Diabetes Federation (IDF)

International Diabetes Federation, Avenue Emile De Mot 19B-1000 Brussels, Belgium, IDF, April 14 2005

The IDF consensus worldwide definition of the metabolic syndrome

Part 1: Worldwide definition for use in clinical practice

Table 1: The new International Diabetes Federation (IDF) definition
According to the new IDF definition, for a person to be defined as having the metabolic       syndrome they must have:

• Central obesity (defined as waist circumference > 94cm for Europid men and

       > 80cm for Europid women, with ethnicity specific values for other groups)

       plus any two of the following four factors:

• raised TG level: > 150 mg/dL (1.7 mmol/L), or specific treatment for this

      lipid abnormality

• reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L*) in males and < 50

      mg/dL (1.29 mmol/L*) in females, or specific treatment for this lipid abnormality

• raised blood pressure: systolic BP 3 130 or diastolic BP 3 85 mm Hg, or

treatment of previously diagnosed hypertension

• raised fasting plasma glucose (FPG) > 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes. If above 5.6 mmol/L or 100 mg/dL, OGTT is strongly recommended but is not necessary to define presence of the syndrome.

4. American Heart Association

American Heart Association, Circulation. 2005;112:3066-3072.

“The incidence of cardiovascular disease (CVD), coronary heart disease (CHD), and type 2 diabetes mellitus (T2DM) has not been well defined in persons with the metabolic syndrome (at least 3 of the following: abdominal adiposity, low HDL cholesterol, high triglycerides, hypertension, and impaired fasting glucose).”

5. American Medical Association

JAMA, the Metabolic Syndrome, Vol. 295 No. 7, February 15, 2006.
 
“Definition of the Metabolic Syndrome

• Abdominal (waist) circumference greater than 40 inches for men or 35 inches for women
• High blood pressure (hypertension)
• Hyperglycemia (fasting blood sugar more than 110 mg/dL)
• Elevated triglycerides (a type of fat in the bloodstream)
• Low levels of high-density lipoprotein, also known as HDL or ‘good cholesterol’ “

II. Use of the term “Metabolic Syndrome” in Medical Practice

1. Cleveland Clinic Foundation, Cleveland, OH

The Cleveland Clinic Foundation uses the National Cholesterol Education Program definition of metabolic syndrome.
See http://www.clevelandclinic.org/heartcenter/pub/women/metabolic.htm.
“The National Cholesterol Education Program has defined five elements of the syndrome:

• an “enlarged waist” – defined as waist measurement of at least 35.2” for women, 40” for men
• high blood pressure - 130/85 or higher
• low levels of good (HDL) cholesterol - less than 50 mg/dl for women and less than 40 mg/dl for men
• elevated levels of blood fats (triglycerides) - 150 mg/dl or more
• insulin resistance - blood glucose (sugar) level is higher than normal, or a fasting blood glucose of 110 mg/dl or more.

An individual with three or more of these five characteristics has the metabolic syndrome.”

   Metabolic Syndrome

    Metabolic syndrome is a long-recognized medical condition, but has been defined only   
    recently. A person is diagnosed with the syndrome when he or she has three of these
    five disorders affecting metabolism:

• High blood pressure
• High blood sugar
• High triglycerides
• Low HDL ('good') cholesterol
• Abdominal obesity

   While any of these factors is unhealthy, the net effect of having at least three of these    
   disorders is even worse, dramatically increasing the risk for cardiovascular disease and    
   diabetes. In fact, metabolic syndrome carries the same cardiovascular risk as smoking
   two packs of cigarettes a day. The good news is that intervention and treatment in a
   comprehensive program can decrease cardiovascular risk and prevent the onset of
   diabetes.

3. Johns Hopkins Hospital, Baltimore, MD

Johns Hopkins Hospital, Baltimore, MD, Johns Hopkins Health Alerts, Special Report, Diabetes and Metabolic Syndrome, 2007.