# K013173: Bioscanner Plus; Lipid Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Oct 22, 2001 after 28 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 K870012 (1987). 5 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 15 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 2.
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220, Polymer Technology Systems, Inc. (1998) Summary page 2.
- K990247: MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470, Polymer Technology Systems, Inc. (1999) Summary page 2.
- K991894: Bioscanner Triglycerides Test Strips, Polymer Technology Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K022898: PTS Panels Lipid Panel Test Strips (2002), 7 descendants of its own
- 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

## Recalls of this device
- Jan 16, 2019 · Class II · Z-1371-2019: 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.

## Indications for use
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. 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), athcrosclerosis, and various liver and renal diseases. Triglycerides measurements arc used in the diagnosis and treamment of patxcnts with diabetes mellitus, nephrosis, lwer obstruction, other diseases involving lipid metabolism , or various endocrinc dzsorders The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

Source page: https://510kreport.com/device/K013173
Methodology: https://510kreport.com/methodology