# K014099: Bioscanner Plus

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Dec 21, 2001 after 8 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: 3 generations back to K870012 (1987). 9 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013173: Bioscanner Plus; Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2001) Summary page 2.
- 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 2.
- K013203: Bioscanner Beyond Glucose Analyzer and Test Strips, Polymer Technology Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- 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
- K182781: PTS Professional Chemistry Kit (2018), 0 descendants of its own

## Indications for use
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians’ offices and in acute and convalescent care facility bedside testing and individuals at home. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K014099
Methodology: https://510kreport.com/methodology