# K101203: Tina-Quant Albumin Gen 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 10, 2010 after 134 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- 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: 2 generations back to K895883 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932950: Tina-Quant Microalbumin, Boehringer Mannheim Corp. (1995) Summary page 2.
- K972929: N Antiserum to Human Albumin, Behring Diagnostics, Inc. (1997) Summary page 2.

## Most influential descendants
- K113072: Tina-Quant Albumin Gen.2 (2012), 0 descendants of its own

## Recalls of this device
- Dec 14, 2018 · Class II · Z-1124-2019: COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

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

Source page: https://510kreport.com/device/K101203
Methodology: https://510kreport.com/methodology