510(k) Report

510(k) · Cleared

Recalled · 2006

Ace Clinical Chemistry System

K930104510(k) TraditionalCleared Aug 23, 1993224-day reviewClass II21 CFR 862.1150Recalls 1

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

Schiapparelli Biosystems, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Aug 23, 1993 after a 224-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided
Aug 23, 1993
Review
224 days
Class
Class II
Product code
JIX
Recalls
1
Predicates
0

7 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 6 descendants cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK930104 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK131975 Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2013
  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 ownK123322 Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent…Alfa Wassermann Diagnostics Technologies, LLC · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 6
2012high 6 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc. · 2013 · cites it directly0descendants
  • 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
  • K123322Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentAlfa Wassermann Diagnostics Technologies, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930104Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
+1K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2013—
+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—
+1K123322Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK…Alfa Wassermann Diagnostics Technologies, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201360
FIG. 1 — Lineage of K930104, 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 JIX? 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc.20130
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
K123322Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentAlfa Wassermann Diagnostics Technologies, LLC20130
K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc.20130
K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 26, 2006Not classifiedZ-0676-06OtherInaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131975 (Alfa Wassermann Diagnostic Technologies, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K930104 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930104: Ace Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930104

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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