510(k) Report

510(k) · Cleared

Cleared

Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent

K113436510(k) TraditionalCleared Jul 12, 2012234-day reviewClass II21 CFR 862.1050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alfa Wassermann · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Cleared on Jul 12, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) after a 234-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Jul 12, 2012
Review
234 days
Class
Class II
Product code
CJE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K931786 (1993). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant clearedK931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK113436 Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L…Alfa Wassermann · 2012
  3. Descendant · cites it directly · 0 of its ownK131351 Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast…Alfa Wassermann Diagnostic Technologies, LLC · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
0 (this device)K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann2012—
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K113436, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251074 Tru Liver Health Test Panelscore 10.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K931786Ace Clinical Chemistry System
Summary page 2
…Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System ACE Reagents (K93 1786) Device The ACE Axcel Clinical Chemistry System consists of two major Descr-iptions: componen…
Schiapparelli Biosystems, Inc.1993—

Also cleared against K931786: 21 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC20130

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K131351 (Alfa Wassermann Diagnostic Technologies, LLC, 2013) has gone furthest, with 0 descendants of its own.
  • 21 other devices also cite its predicate K931786.

How does its category compare?

All CJE devices

CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · CJE

1in 2025

2008: 12011: 22012: 12013: 22017: 22018: 12019: 12023: 12024: 12025: 1
2007high 2 (2011) · low 0 (2007)2026

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

2008: 82011: 12013: 1
2007high 8 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CJE

10in 2025

2010: 32011: 242019: 12020: 12021: 12022: 62023: 112024: 112025: 10
2007high 24 (2011) · low 0 (2007)2025

MAUDE reports naming product code CJE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—80
20090—00
20100—03
20112—124
20121—00
20132—10
20140—00
20150—00
20160—00
20172—00
20181—00
20191—01
20200—01
20210—01
20220—06
20231—011
20241—011
20251—010
20260—0—

What is it indicated for?

The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. 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 or physician office laboratories. For in vitro diagnostic use only. The ACE Amylase Reagent is…

Read the full statement (198 words)

The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. 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 or 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 using the ACE Axcel Clinical Chemistry System. 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 or physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Axcel Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Indications for use as stated in the FDA summary.

Also cleared against K931786

21 other devices cite the same predicate.

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC · 20131 recall
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012

More from Alfa Wassermann

4 FDA decisions under this applicant name. See the company

  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace…Alfa Wassermann · 2012

Recent decisions in CJE

The CJE category page

  • K251074Tru Liver Health Test PanelTruvian Health · 2025
  • K240468Alkaline PhosphataseAbbott Laboratories Diagnostics Division · 2024
  • K223317Alkaline Phosphatase2Abbott Ireland Diagnostics Division · 2023
  • K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019
  • K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B. · 2018

https://510kreport.com/device/K113436 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113436: Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113436

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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