# K113072: Tina-Quant Albumin Gen.2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations
- Decided: May 14, 2012 after 210 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895883 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101203: Tina-Quant Albumin Gen 2, Roche Diagnostics (2010) Summary page 2.

## Indications for use
The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Source page: https://510kreport.com/device/K113072
Methodology: https://510kreport.com/methodology