# K083896: Destiny Max Coagulation Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech
- Decided: Jul 2, 2009 after 185 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K021162 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished, Sigma Diagnostics, Inc. (2002) Summary page 1.

## Indications for use
The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Source page: https://510kreport.com/device/K083896
Methodology: https://510kreport.com/methodology