510(k) Report

510(k) · Cleared

Cleared

S-Test Lactate Dehydrogenase (LD), Model RC 0017

K091544510(k) TraditionalCleared Sep 9, 2009105-day reviewClass II21 CFR 862.1440

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

Alfa Wassermann, Inc. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Cleared on Sep 9, 2009 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) after a 105-day review. Its family tree reaches back 1 generation to 1993.

Decided
Sep 9, 2009
Review
105 days
Class
Class II
Product code
CFJ
Recalls
None
Predicates
1

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

K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 199319901995200020052010
K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK091544 S-Test Lactate Dehydrogenase (LD), Model RC 0017Alfa Wassermann, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
0 (this device)K091544S-Test Lactate Dehydrogenase (LD), Model RC 0017Alfa Wassermann, Inc.2009—
FIG. 1 — Lineage of K091544, 1993–2009Source: 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 CFJ? 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? (2)

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
…analyzer/reagent system predicate: Devices: Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent (k93 1786) Device The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with Description: the S40 Clinical…
Schiapparelli Biosystems, Inc.1993—
*—Alfa Wassermann ACE plus ISE/Clinical Chemistry System
Named without a submission number
—

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?

  • Its one ancestor has no recall.
  • 21 other devices also cite its predicate K931786.

How does its category compare?

All CFJ devices

CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · CFJ

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFJ

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

Recalls per year · CFJ

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CFJ

12in 2025

2010: 42011: 32012: 12016: 42017: 152018: 102019: 182020: 102021: 102022: 82023: 32024: 102025: 12
2007high 18 (2019) · low 0 (2007)2025

MAUDE reports naming product code CFJ, 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—00
20080—00
20091—00
20100—04
20110—03
20120—01
20131—10
20140—00
20150—00
20160—04
20170—015
20180—110
20190—018
20200—010
20210—010
20220—08
20230—03
20240—010
20250—012
20260—0—

What is it indicated for?

The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. 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, Inc.

5 FDA decisions under this applicant name. See the company

  • K091413S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)Alfa Wassermann, Inc. · 2009
  • K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc. · 2009
  • K080073S-Test Creatinine (Cre)Alfa Wassermann, Inc. · 2008
  • K063306Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls…Alfa Wassermann, Inc. · 2007

Recent decisions in CFJ

The CFJ category page

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K051108Piccolo Lactate Dephydrogenase Test SystemAbaxis, Inc. · 2005
  • K974859Lactane Dehydrogenase-SL Assay, Catalogue Number 327-10, 327-30Diagnostic Chemicals, Ltd. · 1998
  • K973589Liquid LDH-L Reagent SetPointe Scientific, Inc., · 19971 recall
  • K970684Lactate Dehydrogenase (LD)Randox Laboratories, Ltd. · 19972 recalls

https://510kreport.com/device/K091544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091544: S-Test Lactate Dehydrogenase (LD), Model RC 0017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091544

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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