510(k) · Cleared
Recalled · Class II · 2014Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, LLC · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Aug 15, 2013 as substantially equivalent to K113253 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) and 4 other predicates after a 97-day review. Its family tree reaches back 2 generations to 1993. It has been recalled once.
- Decided
- Aug 15, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- CJE
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K931786 (1993). 5 ancestors in all, the oldest K930104 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
- 1 generation backK113253 Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- This deviceK131351 Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast…Alfa Wassermann Diagnostic Technologies, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931786 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | 1993 | — |
| −1 | K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| 0 (this device) | K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace… | 2012 |
| * | K931786 | Ace Clinical Chemistry SystemSummary page 1…agent system predicates: Devices: Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE ____________Reagents (KI 13253. K931786, K930104, KI 13436. KI 13382) 54 Device In the ACE Alkaline Phosphatase Reagent assay, alkaline… | 1993 |
| * | K930104 | Ace Clinical Chemistry SystemSummary page 1…tem predicates: Devices: Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE ____________Reagents (KI 13253. K931786, K930104, KI 13436. KI 13382) 54 Device In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphata… | 1993 |
| * | K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentSummary page 10…62 Performance Data: POL - Precision for ACE and ACE A/era Clinical Chemistry Systems Precision - (Note: Please refer to previously cleared submissions k1 13436 (ALP and Amylase) and POL k1 13382 (ALT and AST) for ACE Axcel POL data)… | 2012 |
| * | K113382 | Ace Alt ReagentSummary page 10…d ACE A/era Clinical Chemistry Systems Precision - (Note: Please refer to previously cleared submissions k1 13436 (ALP and Amylase) and POL k1 13382 (ALT and AST) for ACE Axcel POL data) ACE Results ACE A/… | 2012 |
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 |
|---|---|---|---|---|
| Mar 5, 2014 | Class II | Z-1529-2014 | Process control | Extremely low absorbance readings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113253.
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. 2013, this device’s year, is highlighted.
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 ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro…
Read the full statement (275 words)
The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131351: Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131351
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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