# K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 31, 1996 after 71 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850281 (1985). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K850281: Calcium, Boehringer Mannheim Corp. (1985) Summary page 1.
- K933125: Berichrom Antithrombin Iii (a), Behring Diagnostics, Inc. (1994) Summary page 1.
- K950707: N Latex Ferritin, Behring Diagnostics, Inc. (1995) Summary page 2.
- K902154: NA Latex Myoglobin Test, Behring Diagnostics, Inc. (1990) Summary page 2.
- K942328: N Latex RF, Behring Diagnostics, Inc. (1994) Summary page 2.
- K883662: Berichrom (R) Antithrombin Iii, Behring Diagnostics, Inc. (1988) Summary page 2.
- K951012: N/T Protein Control PY, Behring Diagnostics, Inc. (1995) Summary page 2.

## Most influential descendants
- K031650: Ferritin Generation 2 (2003), 0 descendants of its own

## Recalls of this device
- Oct 11, 2010 · Not classified · Z-1824-2011: Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of
- Oct 11, 2010 · Not classified · Z-1823-2011: The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

## Indications for use
The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYO T Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.

Source page: https://510kreport.com/device/K963292
Methodology: https://510kreport.com/methodology