# K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A

- Pathway: 510(k) (Traditional)
- Applicant: Hyphen Biomed
- Decided: Sep 7, 2007 after 126 days
- Product code: LCO (Platelet Factor 4 Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 864.7695
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983379 (1999). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003767: Asserachrom Hpia Test Kit, Diagnostica Stago, Inc. (2001) Summary page 1.
- K053559: PF4 Enhanced Solid Phase Elisa, Genetic Testing Institute (2006) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Apr 1, 2026 · Class II · Z-2171-2026: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Jul 19, 2019 · Class II · Z-2347-2019: Residual crystallization of the microplate and recurrent negative controls out of range.
- Jul 19, 2019 · Class II · Z-2346-2019: Residual crystallization of the microplate and recurrent negative controls out of range.
- Feb 5, 2018 · Class II · Z-1743-2018: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Feb 5, 2018 · Class II · Z-1744-2018: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Feb 5, 2018 · Class II · Z-1742-2018: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Nov 9, 2011 · Class II · Z-1062-2018: A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
- Nov 9, 2011 · Class II · Z-1063-2018: A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.

## Indications for use
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).

Source page: https://510kreport.com/device/K071255
Methodology: https://510kreport.com/methodology