# K003767: Asserachrom Hpia Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Feb 12, 2001 after 68 days
- Product code: LCO (Platelet Factor 4 Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 864.7695
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has 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
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A (2007), 2 descendants of its own
- K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls (2017), 1 descendant of its own
- K243374: HemosIL CL HIT-IgG (PF4-H) (2025), 0 descendants of its own
- K153137: HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) Controls (2016), 0 descendants of its own

## Recalls of this device
- Dec 15, 2025 · Class II · Z-1084-2026: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

Source page: https://510kreport.com/device/K003767
Methodology: https://510kreport.com/methodology