# K982382: Cobas Integra Reagent Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Sep 28, 1998 after 82 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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: 1 generation back to K800119 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972640: Tina-Quant Alpha Particle-1-Antitrypsin Assay, Boehringer Mannheim Corp. (1998) Summary page 3.
- K955907: Boehringer Mannheim Iga Assay, Boehringer Mannheim Corp. (1996) Summary page 3.
- K955908: Boehringer Mannheim Igm Assay, Boehringer Mannheim Corp. (1996) Summary page 3.
- K955906: Boehringer Mannheim Igg Assay, Boehringer Mannheim Corp. (1996) Summary page 3.
- K800119: Immunoglobulin G Reagent System, Calbiochem-Behring Corp. (1980) Summary page 3.

## Recalls of this device
- Dec 15, 2006 · Not classified · Z-0356-2007: Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700

## Indications for use
The cassette COBAS INTEGRA α-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human α-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, α-1-antitrypsin deficiency has been associated with pulmonary emphysema. The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. In addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. The cassette COBAS INTEGRA Immunoglobulin G (Turbidimetric) (IGGT/IGGTC) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin G in serum, plasma (IGGT) and cerebrospinal fluid (IGGTC). Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K982382
Methodology: https://510kreport.com/methodology