# K991894: Bioscanner Triglycerides Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: May 24, 2000 after 356 days
- Product code: JGY (Colorimetric Method, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870012 (1987). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870012: Triglyceride (Gpo-Trinder) Reagent, Sigma Diagnostics, Inc. (1987) Summary page 1.

## Most influential descendants
- K013173: Bioscanner Plus; Lipid Panel Test Strips (2001), 9 descendants of its own
- 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

## Indications for use
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K991894
Methodology: https://510kreport.com/methodology