Roll of 160 printer labels for printing patient results on CardioChek PA/Plus, typically patient results are printed in duplicate on two labels where one is given to patient and other is adhered to patient chart or records.
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 PA Analyzer when you purchase: at least 10 boxes of Lipid Strips; at least 10 boxes of TC/HDL/Glu Strips; or at least 20 boxes of Total Cholesterol Strips
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 TC/HDL/Glu strips; or at least 10 boxes of Total Cholesterol Strips
Test strips must be purchased at regular price.
Must call to receive
the discounted price.
