# K870012: Triglyceride (Gpo-Trinder) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Feb 20, 1987 after 49 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, 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
No predicates in its family tree.
13 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991894: Bioscanner Triglycerides Test Strips (2000), 12 descendants of its own
- 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

Source page: https://510kreport.com/device/K870012
Methodology: https://510kreport.com/methodology