510(k) · Cleared
Recalled · 2008Liquid Alkaline Phoshatase Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Oct 22, 1997 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 18 times.
- Decided
- Oct 22, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- CJE
- Recalls
- 18
- 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
- #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’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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2008 | Not classified | Z-1355-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1360-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1356-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1358-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1354-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1353-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1359-2008 | Other | May be contaminated with microorganisms. |
| Feb 7, 2008 | Not classified | Z-1357-2008 | Other | May be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1389-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1392-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1390-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1393-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1394-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1397-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1396-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1388-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1395-06 | Other | The reagent may be contaminated with microorganisms. |
| Jun 9, 2006 | Not classified | Z-1391-06 | Other | The reagent may be contaminated with microorganisms. |
The 5 latest of 18 recalls; the web page lists all.
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 product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.
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/K973588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973588: Liquid Alkaline Phoshatase Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973588
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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