510(k) Report

510(k) · Cleared

Cleared

Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent

K113253510(k) TraditionalCleared May 17, 2012197-day reviewClass I21 CFR 862.2160

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

Alfa Wassermann Diagnostic Technologies, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on May 17, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) after a 197-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.

Decided
May 17, 2012
Review
197 days
Class
Class I
Product code
JJE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K931786 (1993). 4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 4 descendants clearedK931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 4 descendants K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK113253 Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  3. Descendant · cites it directly · 0 of its ownK131488 Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo…Alfa Wassermann Diagnostics Technologies, LLC · 2013
  4. Descendant · cites it directly · 0 of its ownK131351 Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast…Alfa Wassermann Diagnostic Technologies, LLC · 2013 · Recalled
  5. Descendant · cites it directly · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
  6. Descendant · cites it directly · 0 of its ownK123018 Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion…Alfa Wassermann Diagnostic Technologies, Inc. · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…Alfa Wassermann Diagnostics Technologies, LLC · 2013 · cites it directly0descendants
  • 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
  • K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc. · 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)K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent…Alfa Wassermann Diagnostics Technologies, LLC2013—
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC20131
+1K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—
+1K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective…Alfa Wassermann Diagnostic Technologies, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201340
FIG. 1 — Lineage of K113253, 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 JJE? 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
…Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE plus ISE/Clinical Chemistry System ___________ACE Reagents (K93 1786) Alfa Wassermann Diagnostic Technologies, LLC 5 10(k) Submission…
Schiapparelli Biosystems, Inc.1993—

Also cleared against K931786: 21 other devices →

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…Alfa Wassermann Diagnostics Technologies, LLC20130
K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC20130
K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130
K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc.20130

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, K131488 (Alfa Wassermann Diagnostics 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 JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

What is it indicated for?

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays for cliniical use in physician office laboratories or clinical laboratories. The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in…

Read the full statement (211 words)

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays for cliniical use in physician office laboratories or clinical laboratories.

The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

* Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance

* Potassium measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

* Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry-System. Glucose measurements are used in the diagnosis aind treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. 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 Diagnostic…

21 FDA decisions under this applicant name. See the company

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) ModuleAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012

Recent decisions in JJE

The JJE category page

  • K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd. · 2019
  • K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, CarCarolina Liquid Chemistries Corp. · 2014
  • K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014
  • K131554RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) ReagentRandox Laboratories, Ltd. · 20143 recalls
  • K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 20136 recalls

https://510kreport.com/device/K113253 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113253: Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113253

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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