510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Ace Alt Reagent

K113382510(k) TraditionalCleared Jul 19, 2012246-day reviewClass I21 CFR 862.1030Recalls 1

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

Alfa Wassermann · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

Cleared on Jul 19, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) after a 246-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it. It has been recalled once.

Decided
Jul 19, 2012
Review
246 days
Class
Class I
Product code
CKA
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K931786 (1993). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 2 descendants clearedK931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 2 descendants K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK113382 Ace Alt ReagentAlfa 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
  4. Descendant · cites it directly · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC · 2013 · cites it directly0descendants
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 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)K113382Ace Alt ReagentAlfa Wassermann2012—
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC20131
+1K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
FIG. 1 — Lineage of K113382, 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 CKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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 1
…edicate Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Reagents (K93 1786) Device In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L- Descriptions:…
Schiapparelli Biosystems, Inc.1993—

Also cleared against K931786: 21 other devices →

What descends from it? (2)

2 later devices cite 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
K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 5, 2014Class IIZ-1530-2014Process controlExtremely low absorbance readings.

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 CKA devices

CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · CKA

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CKA

Too few CKA 510(k)s in any year since 2007 to give a median.

Recalls per year · CKA

1in 2016

2007: 82010: 12016: 1
2007high 8 (2007) · low 0 (2008)2026

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

Adverse event reports per year · CKA

8in 2025

2010: 82011: 392012: 82017: 22018: 12020: 32021: 22022: 22023: 42024: 102025: 8
2007high 39 (2011) · low 0 (2007)2025

MAUDE reports naming product code CKA, 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—80
20080—00
20090—00
20100—18
20110—039
20121—08
20131—00
20140—00
20150—00
20160—10
20170—02
20180—01
20190—00
20200—03
20210—02
20220—02
20230—04
20240—010
20250—08
20260—0—

What is it indicated for?

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. 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 or physician office laboratories. For in vitro diagnostic use only. The ACE AST…

Read the full statement (188 words)

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

The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. 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
  • K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann · 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
  • K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann · 2012
  • K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace…Alfa Wassermann · 2012

Recent decisions in CKA

The CKA category page

  • K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge AstHitachi Chemical Diagnostics, Inc. · 2013
  • K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino…Dade Behring, Inc. · 20061 recall
  • K020487Careside AltCareside, Inc. · 2002
  • K980028Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1998
  • K973869Trace Reagent Line for the Cobas MiraTrace America, Inc. · 1998

https://510kreport.com/device/K113382 · printed Nov 5, 2026

Cite this page

510(k) Report. “K113382: Ace Alt Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113382

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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