# K990552: Immunoglobulin a Test System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 25, 1999 after 31 days
- Product code: CFQ (Radioimmunoassay, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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 K922273 (1992). 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)
- K922273: Array (R) 360, Beckman Instruments, Inc. (1992) Summary page 1.

## Indications for use
The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.

Source page: https://510kreport.com/device/K990552
Methodology: https://510kreport.com/methodology