# K071507: PTS Panels Chol+HDL+Glu Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Sep 10, 2007 after 101 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980731 (1998). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220, Polymer Technology Systems, Inc. (1998) Summary page 2.
- K990688: MTM Bioscanner C Test Strips, Polymer Technology Systems, Inc. (1999) Summary page 2.
- K060617: PTS Panels HDL Cholesterol Test Strips, Polymer Technology Systems, Inc. (2006) Summary page 2.
- K013068: Bioscanner 2000, Polymer Technology Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K162282: CardioChek Plus Test System, CardioChek Home Test System (2016), 0 descendants of its own
- K142302: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System (2014), 0 descendants of its own

## Recalls of this device
- Jan 16, 2019 · Class II · Z-1373-2019: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
- Mar 15, 2016 · Class II · Z-0741-2020: This lot of test strips is showing an under-recovery when tested against a reference method.
- Jul 6, 2010 · Not classified · Z-2641-2010: The test strips appear to under-recover Cholesterol, HDL and glucose.
- Aug 4, 2009 · Not classified · Z-1012-2010: Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lo

## Indications for use
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

Source page: https://510kreport.com/device/K071507
Methodology: https://510kreport.com/methodology