# K050113: Tina-Quant Igg Gen.2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 8, 2005 after 21 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 K943997 (1994). 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)
- K943997: Behring Nephelometer II, Behring Diagnostics, Inc. (1994) Summary page 5.

## Most influential descendants
- K073490: Olympus Igg Reagent (2008), 3 descendants of its own
- K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (2017), 1 descendant of its own
- K221114: Immunoglobulin G (IgG) (2023), 0 descendants of its own
- K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (2020), 0 descendants of its own

## Indications for use
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG 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/K050113
Methodology: https://510kreport.com/methodology