# K040435: Roche Diagnostics Tina-Quant Iga Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 10, 2004 after 20 days
- Product code: CZP (Iga, Antigen, Antiserum, Control)
- 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
Longest line of descent: 1 generation back to K955907 (1996). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955907: Boehringer Mannheim Iga Assay, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus (2012), 3 descendants of its own
- K191985: Optilite IgA Kit (2019), 1 descendant of its own
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own
- K192116: Human IgA liquid reagent kit for Use on SPAPlus (2019), 0 descendants of its own

## Recalls of this device
- Jun 3, 2019 · Class II · Z-1979-2019: Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.

## Indications for use
Immanoturbidimetric assay for the quantitative in vitro determination of IgA 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/K040435
Methodology: https://510kreport.com/methodology