510(k) · Cleared
ClearedAlkaline Phosphatase (Alkp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on May 20, 1998 as substantially equivalent to K902560 (Roche Diagnostic Systems, Inc., 1990) after a 44-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 20, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902560 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902560 Roche Cobas Ready Alkaline Phosphatase ReagentRoche Diagnostic Systems, Inc. · 1990
- This deviceK981245 Alkaline Phosphatase (Alkp)Abbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902560 | Roche Cobas Ready Alkaline Phosphatase Reagent | Roche Diagnostic Systems, Inc. | 1990 | — |
| 0 (this device) | K981245 | Alkaline Phosphatase (Alkp) | Abbott Laboratories | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K902560 | Roche Cobas Ready Alkaline Phosphatase ReagentSummary page 1…stantial Equivalence: - The Alkaline Phosphatase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Alkaline Phosphatase assay (K902560). Both assays are in vitro clinical chemistry methods. Both assays can be used for the Alkaline Phosphatase 510(k) Section IT A… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in
serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis
and treatment of liver, bone, parathyroid, and intestinal diseases.
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/K981245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981245: Alkaline Phosphatase (Alkp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981245
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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