510(k) · Cleared
ClearedAlkaline Phosphatase-SL Assay Catalogue Number 309-10, 309-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Feb 12, 1998 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 12, 1998
- Review
- 16 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several general disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis.…
Read the full statement (171 words)
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several general disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis. (1)
Alkaline phosphatase (AP) activity was first measured by Kay (2). Since that time many substrates such as glycerol phosphate and phenyl phosphate have been used. Bessey, Lowry, and Brock (3) introduced a more sensitive substrate p-nitrophenyl phosphate (p-NPP). Several recommendations have been made on the optimum conditions for the determination of AP in serum. These suggestions have been put forth by the German Society for Clinical Chemistry (4) as well as by the committee on enzymes of the Scandinavian Society for Clinical Chemistry (5). This method is in accordance with the recommendations of the International Federation of Clinical Chemistry (IFCC) for AP measurement in serum (6).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980316: Alkaline Phosphatase-SL Assay Catalogue Number 309-10, 309-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980316
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026