510(k) Report

510(k) · Cleared

Cleared

Ace Clinical Chemistry System

K931786510(k) TraditionalCleared Sep 21, 1993165-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

Schiapparelli Biosystems, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Sep 21, 1993 after a 165-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 30 later devices descend from it.

Decided
Sep 21, 1993
Review
165 days
Class
Class I
Product code
JJE
Recalls
None
Predicates
0

30 later devices descend from it, 22 citing it directly.

Descendants, by year cleared 2012: 13 descendants cleared2013: 6 descendants cleared2008: 8 descendants cleared2009: 2 descendants cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. Descendant · cites it directly · 4 of its ownK113253 Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  3. Descendant · cites it directly · 2 of its ownK113382 Ace Alt ReagentAlfa Wassermann · 2012 · Recalled
  4. Descendant · cites it directly · 2 of its ownK091413 S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol…Alfa Wassermann, Inc. · 2009
  5. Descendant · cites it directly · 1 of its ownK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  6. Descendant · cites it directly · 1 of its ownK113374 Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo…Alfa Wassermann Diagnostic Technologies, Inc. · 2012

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2008: 82009: 22011: 12012: 132013: 6
2008high 13 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 30 · See all
  • K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly4descendants
  • K113382Ace Alt ReagentAlfa Wassermann · 2012 · cites it directly2descendants
  • K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…Alfa Wassermann, Inc. · 2009 · cites it directly2descendants
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly1descendant
  • K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
+1K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K113382Ace Alt ReagentAlfa Wassermann20121
+1K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model…Alfa Wassermann, Inc.2009—
+1K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…Alfa Wassermann Diagnostic Technologies, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200880
200920
201110
2012130
201360
FIG. 1 — Lineage of K931786, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K113253Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…Alfa Wassermann Diagnostic Technologies, Inc.20124
K113382Ace Alt ReagentAlfa Wassermann20122
K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…Alfa Wassermann, Inc.20092
K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121
K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121
K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L ReagentAlfa Wassermann20121
K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20121
K113435Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…Alfa Wassermann20121
K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Alfa Wassermann Diagnostic Technologies, Inc.20121
K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.20081

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?

  • Of its descendants, K113253 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 4 descendants of its own.

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.

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—

More from Schiapparelli Biosystems, Inc.

24 FDA decisions under this applicant name. See the company

  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999
  • K981375Ace T Uptake Reagent TU CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K973583Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997

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/K931786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931786: Ace Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931786

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026