510(k) · Cleared
ClearedCobas Reagent for Alkaline Phosphatase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Analytical Instruments, Inc. · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Jun 20, 1980 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 20, 1980
- Review
- 24 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK801242 Cobas Reagent for Alkaline PhosphataseRoche Analytical Instruments, Inc. · 1980
- Descendant · cites it directly · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801242 | Cobas Reagent for Alkaline Phosphatase | Roche Analytical Instruments, Inc. | 1980 | — |
| +1 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| +2 | K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | Seppim S.A.S. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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 CJE? 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 CJE device
- #1 K251074 Tru Liver Health Test Panelscore 10.8 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060205 (Horiba Abx, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CJE devicesCJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJE
Too few CJE 510(k)s in any year since 2007 to give a median.
Recalls per year · CJE
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJE
10in 2025
MAUDE reports naming product code CJE, 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 | 1 | — | 8 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 2 | — | 1 | 24 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K801242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K801242: Cobas Reagent for Alkaline Phosphatase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801242
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026