15 Multi-Panel Cardio Risk Total Cholesterol+HDL+Glucose test strips for CardioChek PA/Plus Analyzer offers a simple, convenient method for large-scale testing of risk factors for 2 of the most common disease states: cardiovascular & diabetes.
Analyzer is sold separately.
MemoChip is shipped with Test Strips and changes color depending on the test panel.
MemoChip and test strips are lot specific and will not work if the lot doesnt match.
The table below displays the K number, CLIA Waived status, and the date the test strip panel was first CLIA Waived.
| ITEM | Description | K Number | Status | Date First CLIA Waived |
|---|---|---|---|---|
| PTS PANELS Glucose Test Strips (Professional) | Glucose test | K972669 | Cleared Jan.22, 1998 | Jul.17, 1998 |
| PTS PANELS Glucose Test Strips (OTC) | Glucose test | K972669 | Cleared Jan.22, 1998 | Jul.17, 1998 |
| PTS PANELS Glucose Control | Glucose control | K972669 | Cleared Jan.22, 1998 | Does not apply |
| PTS PANELS Cholesterol (Professional) | Cholesterol test | K981493 | Cleared July 22, 1998 | |
| PTS PANELS Cholesterol(OTC) | Cholesterol test | K990688 | Cleared June 24, 1999 | Aug. 19, 1999 |
| PTS PANELS HDL (Professional) | HDL test | K990247 | Cleared May 28, 1999 | |
| PTS PANELS HDL (OTC) | HDL test | K993377 | Cleared Jan.13, 2000 | Feb.28,2000 |
| PTS PANELS Triglycerides (Professional) | Triglyceride test | K991894 | Cleared May 24, 2000 | |
| PTS PANELS Triglycerides (OTC) | Triglyceride test | K000586 | Cleared July 3, 2000 | Jul. 3, 2000 |
| Lipid Panel Test Strips (Professional) | Multi-test strip for cholesterol, HDL, and triglycerides | K013173 | Cleared Oct. 22, 2001 | |
| Q3 Glucose Analyzer (Professional and OTC) | Hand-held amperometric glucose analyzer | K013203 | Cleared Nov.16, 2001 | Nov. 16, 2001 |
| CardioChek Professional and OTC Glucoses | CardioChek with PTS PANELS Test Strips (colorimetric) and PTS PANELS Advanced Glucose Test Strips (amperometric) | K014099 | Cleared Dec.21, 2001 | Dec.21,2001 |
| PTS PANELS Multi-Chemistry Controls | Multi-constituent controls for use with PTS PANELS Test Strips | K022401 | Cleared Aug.21, 2002 | Does not apply |
| PTS PANELS Lipid Panel Test Strips (Professional) | Multi-test strip for cholesterol, HDL, and triglycerides. Special 510(k) with revised claims | K022898 | Cleared Sept. 24, 2002 | Oct. 18, 2002 |
| PTS PANELS Lipid Panel Test Strips (OTC) | Multi-test strip for cholesterol, HDL, and triglycerides. | K023558 | Cleared Nov. 15, 2002 | Nov. 15, 2002 |
Must call to receive a FREE CardioChek PLUS Analyzer when you purchase: at least 10 boxes of Lipid Strips or at least 10 boxes of Lipid/eGlu Bundles at regular price.
Test strips must be purchased at regular price.
Must call to receive
discounted CardioChek PA Analyzer
when you purchase: at least 5 boxes of Lipid Strips or at least 5 boxes of Lipid/eGlu Bundles strips at regular price.
Test strips must be purchased at regular price.
Must call to receive
the discounted price.
