510(k) Report

510(k) · Cleared

Cleared

S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast

K072142510(k) TraditionalCleared Jun 26, 2008329-day reviewClass II21 CFR 862.1050

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. · CKF Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Cleared on Jun 26, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 329-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jun 26, 2008
Review
329 days
Class
Class II
Product code
CKF
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 1996: 1 other ancestor1995: 1 other ancestorK931786 · 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 deviceK072142 S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstAlfa 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)K072142S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstAlfa Wassermann Diagnostic Technologies, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
FIG. 1 — Lineage of K072142, 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 CKF? 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
…ers for analyzer/reagent system predicates are: Devices 1. ACE plus ISE/ Clinical Chemistry System ACE Alkaline Phosphatase Reagent (K93 1786) ACE Amylase Reagent (K93 1786) ACE Aspartate Aminotransferase Reagent (K93 1786)…
Schiapparelli Biosystems, Inc.1993—
*K961274Olympus AU600 Clinical Chemistry Analyzer
Summary page 1
…E Aspartate Aminotransferase Reagent (K93 1786) 2. OlyMpus AU640 Clinical Chemistry Analyzer Alkaline Phosphatase Reagent (K96 1274) Amylase Reagent (K96 1274) Aspartate Aminotransferase Reagent (K96 1274)…
Olympus America, Inc.19967
*K942782Piccolo (TM)
Summary page 1
…Aspartate Aminotransferase Reagent (K96 1274) 3. Piccolos xpress Chemistry Analyzer Alkaline Phosphatase Reagent (K942782) Amylase Reagent (K942782) Aspartate Aminotransferase Reagent (K942782) === Page…
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 CKF devices

CKF Phenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · CKF

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CKF

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

Recalls per year · CKF

No recall names CKF since 2007.

Adverse event reports per year · CKF

No MAUDE report names CKF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The S-Test Amylase…

Read the full statement (182 words)

The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements 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.

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 CKF

The CKF category page

  • K963383Hichem Alp/Amp Reagent KitHichem Diagnostics · 1996

https://510kreport.com/device/K072142 · printed Nov 3, 2026

Cite this page

510(k) Report. “K072142: S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072142

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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