# K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Aug 30, 2002 after 141 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AMAX 190 Coagulation Analyzer: named in the summary without a submission number

## Most influential descendants
- K082248: Sta Satellite Automated Multi-Parameter Analyzer (2008), 1 descendant of its own
- K253658: STA Satellite Max® (2026), 0 descendants of its own
- K083896: Destiny Max Coagulation Analyzer (2009), 0 descendants of its own

## Indications for use
The AMAX DestinyTM 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/K021162
Methodology: https://510kreport.com/methodology