# K033009: Roche Diagnostics Cobas Integra Albumin Gen. 2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 16, 2003 after 20 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951595 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Recalls of this device
- Aug 27, 2020 · Class III · Z-0104-2021: Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contam
- Sep 11, 2019 · Class III · Z-0152-2020: Due to low Quality Control recovery and invalid Calibration.
- Jun 11, 2008 · Not classified · Z-0011-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

## Indications for use
The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Source page: https://510kreport.com/device/K033009
Methodology: https://510kreport.com/methodology