# K052697: Heparin/Platelet Factor 4 Antibody Serum Panel

- Pathway: 510(k) (Traditional)
- Applicant: Akers Biosciences, Inc.
- Decided: Jan 4, 2006 after 98 days
- Product code: GGN (Plasma, Coagulation Control)
- 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 K983379 (1999). 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)
- K983379: Gti-PF4 Elisa, Genetic Testing Institute (1999) Summary page 1.

## Indications for use
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin PF4 Antibody Assay. Included are both confirmed positive and negative control panel members. The panel members enable the users to evaluate their PIFA® Heparin PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.

Source page: https://510kreport.com/device/K052697
Methodology: https://510kreport.com/methodology