# K040434: Roche Diagnostics Tina-Quant Igg Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 10, 2004 after 20 days
- Product code: DEW (Igg, Antigen, Antiserum, Control)
- 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 K955906 (1996). 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)
- K955906: Boehringer Mannheim Igg Assay, Boehringer Mannheim Corp. (1996) Summary page 1.

## Indications for use
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K040434
Methodology: https://510kreport.com/methodology