510(k) · Cleared
Recalled · Class III · 2020Roche Diagnostics Cobas Integra Albumin Gen. 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Oct 16, 2003 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after a 20-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 3 times.
- Decided
- Oct 16, 2003
- Review
- 20 days
- Class
- Class II
- Product code
- CIX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951595 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK033009 Roche Diagnostics Cobas Integra Albumin Gen. 2Roche Diagnostics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| 0 (this device) | K033009 | Roche Diagnostics Cobas Integra Albumin Gen. 2 | Roche Diagnostics Corp. | 2003 | — |
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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 1…in human serum and plasma. Predicate We claim substantial equivalence to the currently marketed COBAS Integra Device Albumin Assay. (K95 1595). 24… | 1995 |
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 |
|---|---|---|---|---|
| Aug 27, 2020 | Class III | Z-0104-2021 | Under Investigation by firm | 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 contamination between the R1 and R3 reagents. |
| Sep 11, 2019 | Class III | Z-0152-2020 | Under Investigation by firm | Due to low Quality Control recovery and invalid Calibration. |
| Jun 11, 2008 | Not classified | Z-0011-2009 | Labeling Change Control | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 31 other devices also cite its predicate K951595.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033009: Roche Diagnostics Cobas Integra Albumin Gen. 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033009
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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