510(k) Report

510(k) · Cleared

Cleared

S-Test C02

K073223510(k) TraditionalCleared Jun 26, 2008224-day reviewClass II21 CFR 862.1160

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. · KHS Enzymatic, Carbon-Dioxide

Cleared on Jun 26, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 224-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jun 26, 2008
Review
224 days
Class
Class II
Product code
KHS
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K931786 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 199319901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK073223 S-Test C02Alfa Wassermann Diagnostic Technologies, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
0 (this device)K073223S-Test C02Alfa Wassermann Diagnostic Technologies, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K073223, 1993–2008Source: 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 KHS? 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
Get a 510(k) Report

What was it cleared against? (3)

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
…ufacturers for analyzer/reagent system predicates are: Devices: 1. ACE plus ISE/Clinical Chemistry System ACE Carbon Dioxide Reagent (K931786) 2. Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer Carbon Dioxide Re…
Schiapparelli Biosystems, Inc.1993—
*K946090Kodak Ektacchem 950IRC Analyzer
Summary page 1
…E Carbon Dioxide Reagent (K931786) 2. Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer Carbon Dioxide Reagent (K946090) 3. Piccolo® xpress Chemistry Analyzer Carbon Dioxide Reagent (K942782) Device…
Clinical Diagnostic Systems, Inc.19951
*K942782Piccolo (TM)
Summary page 1
…yzer Carbon Dioxide Reagent (K946090) 3. Piccolo® xpress Chemistry Analyzer Carbon Dioxide Reagent (K942782) Device The S-Test Carbon dioxide (CO2) reagent cartridge, used with the S40 Description: Clinical Analyzer, is inte…
Abaxis, Inc.19951

Also cleared against K931786: 21 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 2 of the 3 ancestors have a recall of any class.
  • 21 other devices also cite its predicate K931786.

How does its category compare?

All KHS devices

KHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KHS

1in 2017

2007: 22008: 12009: 12010: 32011: 12012: 22013: 22014: 12016: 12017: 1
2007high 3 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KHS

143in 2010

2010: 143 days median
2007high 143 (2010)2026

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

Recalls per year · KHS

1in 2025

2013: 12019: 12023: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · KHS

40in 2025

2008: 22009: 142011: 52012: 32013: 22014: 62015: 12016: 42017: 72018: 152019: 352020: 312021: 142022: 102023: 252024: 302025: 40
2007high 40 (2025) · low 0 (2007)2025

MAUDE reports naming product code KHS, 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
20072—00
20081—02
20091—014
2010314300
20111—05
20122—03
20132—12
20141—06
20150—01
20161—04
20171—07
20180—015
20190—135
20200—031
20210—014
20220—010
20230—125
20240—030
20250—140
20260—0—

What is it indicated for?

The S-Test Carbon Dioxide Reagent is intended for the quantitative determination of carbon dioxide concentration in serum or heparin plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. 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 KHS

The KHS category page

  • K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc. · 2017
  • K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd. · 2016
  • K140248S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014
  • K131546AU Bicarbonate ReagentBeckman Coulter Ireland, Inc. · 20134 recalls
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013

https://510kreport.com/device/K073223 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073223: S-Test C02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073223

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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