510(k) · Cleared
Recalled · 2006Cobas Integra Reagent Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Sep 28, 1998 as substantially equivalent to K972640 (Boehringer Mannheim Corp., 1998) and 4 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1980. It has been recalled once.
- Decided
- Sep 28, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- CFN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K800119 (1980). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK800119 Immunoglobulin G Reagent SystemCalbiochem-Behring Corp. · 1980
- This deviceK982382 Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800119 | Immunoglobulin G Reagent System | Calbiochem-Behring Corp. | 1980 | — |
| 0 (this device) | K982382 | Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972640 | Tina-Quant Alpha Particle-1-Antitrypsin AssaySummary page 3…tems, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number COBAS INTEGRA Boehringer Mannheim a-1- 1/9/98 K972640 o-[-Antitrypsin Reagent Cassette Antitrypsin Reagent (AAT) Roche COBAS INTEGRA Boehringer Mannheim 2/9/96 K955907 [mmunoglobulin… | 1998 |
| * | K955907 | Boehringer Mannheim Iga AssaySummary page 3…Number COBAS INTEGRA Boehringer Mannheim a-1- 1/9/98 K972640 o-[-Antitrypsin Reagent Cassette Antitrypsin Reagent (AAT) Roche COBAS INTEGRA Boehringer Mannheim 2/9/96 K955907 [mmunoglobulin A Reagent Cassette |Immunoglobulin A Reagent IGA/IGAP) Roche COBAS INTEGRA | Boehninger Mannheim 2/9/96 K955908 I… | 1996 |
| * | K955908 | Boehringer Mannheim Igm AssaySummary page 3…COBAS INTEGRA Boehringer Mannheim 2/9/96 K955907 [mmunoglobulin A Reagent Cassette |Immunoglobulin A Reagent IGA/IGAP) Roche COBAS INTEGRA | Boehninger Mannheim 2/9/96 K955908 Immunoglobulin M Reagent Cassette|Immunoglobulin M Reagent (IGM/IGMP) Roche COBAS INTEGRA Boehringer Mannheim 2/9/96 K955906 Immu… | 1996 |
| * | K955906 | Boehringer Mannheim Igg AssaySummary page 3…e COBAS INTEGRA | Boehninger Mannheim 2/9/96 K955908 Immunoglobulin M Reagent Cassette|Immunoglobulin M Reagent (IGM/IGMP) Roche COBAS INTEGRA Boehringer Mannheim 2/9/96 K955906 Immunoglobulin G Reagent Cassette {Immunoglobulin G Reagent and (IGGT/IGGTC) Behring Diagnostics 2/5/80 K800119 Immunoglobulin G… | 1996 |
| * | K800119 | Immunoglobulin G Reagent SystemSummary page 3…(IGM/IGMP) Roche COBAS INTEGRA Boehringer Mannheim 2/9/96 K955906 Immunoglobulin G Reagent Cassette {Immunoglobulin G Reagent and (IGGT/IGGTC) Behring Diagnostics 2/5/80 K800119 Immunoglobulin G Reagent 1 026 Roche Diagnostic Systems, Inc. COBAS® INTEGRA Reagent Cassettes Somerville, New… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2006 | Not classified | Z-0356-2007 | Other | 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 and 800 analyzers and the R1 reagent… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (282 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982382: Cobas Integra Reagent Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982382
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026