510(k) · Cleared
Recalled · 2005Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Feb 9, 1996 after a 266-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 9, 1996
- Review
- 266 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK952337 Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N…Roche Diagnostic Systems, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK961824 Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK030553 Arkit HBA1CArkray, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK990992 Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp. · 1999
Most influential descendants
Showing 3 of 3 · See all- K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
- K030553Arkit HBA1CArkray, Inc. · 2003 · cites it directly0descendants
- K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952337 | Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P | Roche Diagnostic Systems, Inc. | 1996 | — |
| +1 | K961824 | Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin | Roche Diagnostic Systems, Inc. | 1996 | — |
| +1 | K030553 | Arkit HBA1C | Arkray, Inc. | 2003 | — |
| +2 | K990992 | Integra Reagent Cassette for Hemoglobin Alc | Roche Diagnostics Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCP? 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 LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2005 | Not classified | Z-0650-05 | Other | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. |
| Feb 15, 2005 | Not classified | Z-0651-05 | Other | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961824 (Roche Diagnostic Systems, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, 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 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952337: Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952337
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026