# K013203: Bioscanner Beyond Glucose Analyzer and Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Nov 16, 2001 after 52 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- 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.
8 later devices descend from it; 1 cites 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)
- K982002: Accu-Chek Comfort Curve Test Strip, Boehringer Mannheim Corp. (1998) Summary page 1.

## Most influential descendants
- K014099: Bioscanner Plus (2001), 7 descendants of its own
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System (2015), 6 descendants of its own
- K163406: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (2017), 1 descendant of its own
- K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (2022), 0 descendants of its own
- K193406: CardioChek Plus Test System; CardioChek Plus Home Test System (2022), 0 descendants of its own

## Indications for use
The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.

Source page: https://510kreport.com/device/K013203
Methodology: https://510kreport.com/methodology