# K013068: Bioscanner 2000

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Nov 20, 2001 after 145 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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: 2 generations back to K980731 (1998). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982002: Accu-Chek Comfort Curve Test Strip, Boehringer Mannheim Corp. (1998) Summary page 2.

## Most influential descendants
- K071507: PTS Panels Chol+HDL+Glu Panel Test Strips (2007), 2 descendants of its own
- K070017: PTS Panels Metabolic Chemistry Panel Test Strips (2007), 1 descendant of its own
- K041750: PTS Panels Chol+Glu Test Panel (2004), 1 descendant of its own
- 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
- Apr 4, 2013 · Class II · Z-1403-2013: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.

## Indications for use
The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure glucose in whole blood and by individuals with diabetes to measure glucose in fingerstick whole blood at home. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Source page: https://510kreport.com/device/K013068
Methodology: https://510kreport.com/methodology