# K961824: Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jul 23, 1996 after 74 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: 1 generation back to K860894 (1986). 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)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 2.
- K952337: Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P, Roche Diagnostic Systems, Inc. (1996) Summary page 1.
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K990992: Integra Reagent Cassette for Hemoglobin Alc (1999), 0 descendants of its own

## Indications for use
The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin A1c contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbA1c%) in hemolysate.

Source page: https://510kreport.com/device/K961824
Methodology: https://510kreport.com/methodology