# K040431: Roche Diagnostics Tina-Quant Igm Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 10, 2004 after 20 days
- Product code: DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955908 (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)
- K955908: Boehringer Mannheim Igm Assay, Boehringer Mannheim Corp. (1996) Summary page 1.

## Recalls of this device
- Dec 17, 2018 · Class II · Z-1147-2019: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have 

## Indications for use
Immmumotibidimetric assay for the quaotitative in vitro determination of IgM 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/K040431
Methodology: https://510kreport.com/methodology