# K993213: K-Assay Iga

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 23, 1999 after 60 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 28, 2022 · Class II · Z-0271-2023: IgA Reagent may start showing cloudiness over time, which can affect assay performance.

## Indications for use
The K-ASSAY IgA Assay is intended to be used for the quantitative determination of IgA in human serum by immunoturbidimetric assay. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993213
Methodology: https://510kreport.com/methodology