# K955907: Boehringer Mannheim Iga Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 9, 1996 after 42 days
- Product code: CZP (Iga, 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040435: Roche Diagnostics Tina-Quant Iga Gen.2 (2004), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K955907
Methodology: https://510kreport.com/methodology