# K041750: PTS Panels Chol+Glu Test Panel

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jul 23, 2004 after 24 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972669: MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner G Test Strip, Norman Glucose Con, Polymer Technology Systems, Inc. (1998) Summary page 5.
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220, Polymer Technology Systems, Inc. (1998) Summary page 5.
- K013068: Bioscanner 2000, Polymer Technology Systems, Inc. (2001)

## Most influential descendants
- K162282: CardioChek Plus Test System, CardioChek Home Test System (2016), 0 descendants of its own

## Recalls of this device
- Mar 14, 2018 · Class II · Z-1543-2018: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

## Indications for use
The Chol+Glu Test Panel is intended to measure cholesterol and glucose in whole blood on a BioScanner Plus (Cardidhek brand) analyzer. The test strips are intended to be used by healthcare professionals and individuals at home to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Source page: https://510kreport.com/device/K041750
Methodology: https://510kreport.com/methodology