# K012359: Tina-Quant Complement C4 Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 29, 2001 after 127 days
- Product code: DBI (Complement C4, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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 K951595 (1995). 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)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Recalls of this device
- Aug 27, 2020 · Class III · Z-0103-2021: Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contam

## Indications for use
In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders.

Source page: https://510kreport.com/device/K012359
Methodology: https://510kreport.com/methodology