510(k) · Cleared
Recalled · 2011ALKP
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 Jun 22, 1998 as substantially equivalent to K823213 (Boehringer Mannheim Corp., 1982) after a 32-day review. Its family tree reaches back 1 generation to 1982. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 1998
- Review
- 32 days
- Class
- Class II
- Product code
- CJE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K823213 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK823213 Diagnostics Alkaline Phosphatase OptimiBoehringer Mannheim Corp. · 1982
- This deviceK981806 ALKPAbbott Laboratories · 1998
- Descendant · cites it directly · 2 of its ownK023807 Modification to AlkpAbbott Laboratories · 2002
- Descendant · 2 generations on · 0 of its ownK240468 Alkaline PhosphataseAbbott Laboratories Diagnostics Division · 2024
- Descendant · 2 generations on · 0 of its ownK223317 Alkaline Phosphatase2Abbott Ireland Diagnostics Division · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823213 | Diagnostics Alkaline Phosphatase Optimi | Boehringer Mannheim Corp. | 1982 | — |
| 0 (this device) | K981806 | ALKP | Abbott Laboratories | 1998 | — |
| +1 | K023807 | Modification to Alkp | Abbott Laboratories | 2002 | — |
| +2 | K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | 2024 | — |
| +2 | K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K823213 | Diagnostics Alkaline Phosphatase OptimiSummary page 1…sphatase in the sample. Substantial Equivalence: The Alkaline Phosphatase assay is substantially equivalent to the Boehringer Mannheim® Alkaline Phosphatase/AMP assay (K823213) on the Hitachi® 717 Analyzer for the serum or plasma applications. Alkaline Phosphatase 510(k) . Section II May 19, 1998 Page… | 1982 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023807 | Modification to Alkp | 2002 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2011 | Not classified | Z-3278-2011 | Pending | The reagent has the potential to be contaminated with mold, the Cladosporium fungal species. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K023807 (Abbott Laboratories, 2002) has gone furthest, with 2 descendants 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 | — |
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/K981806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981806: ALKP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981806
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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