510(k) · Cleared
ClearedTrace Scientific Alkaline Phosphatase, Two Part Liquid, Model TR-113
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Dma, Inc. · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Oct 9, 2001 after a 64-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 9, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Roche Diagnostics Alkaline Phosphatase Named without a submission number |
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?
This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma.
Measurements of Alkaline Phosphatase or its isoenzymes are used as 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/K012518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012518: Trace Scientific Alkaline Phosphatase, Two Part Liquid, Model TR-113.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012518
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026