510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard

K103615510(k) TraditionalCleared Sep 8, 2011273-day reviewClass II21 CFR 862.1770Recalls 1

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. · CDN Urease, Photometric, Urea Nitrogen

Cleared on Sep 8, 2011 as substantially equivalent to K954000 (Roche Diagnostic Systems, Inc., 1995) and 4 other predicates after a 273-day review. Its family tree reaches back 1 generation to 1988. It has been recalled once.

Decided
Sep 8, 2011
Review
273 days
Class
Class II
Product code
CDN
Recalls
1
Predicates
5

Its longest line of descent runs back 1 generation to K875285 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1990: 2 other ancestors1988: 1 other ancestorK875285 · Multi-Chemistry Linearity Standard · Verichem Laboratories, Inc. · 1988198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors K875285 · Multi-Chemistry Linearity Standard · Verichem Laboratories, Inc. · 19880
  1. Root · 1 generation backK875285 Multi-Chemistry Linearity StandardVerichem Laboratories, Inc. · 1988
  2. This deviceK103615 Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine…Alfa Wassermann Diagnostic Technologies, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K875285Multi-Chemistry Linearity StandardVerichem Laboratories, Inc.1988—
0 (this device)K103615Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199020
199510
FIG. 1 — Lineage of K103615, 1988–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CDN? 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? (5)

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
*K954000Roche Reagent for Bun
Summary page 2
…Roche Diagnostics COBAS INTEGRA reagents: Reagent 510(k)# Urea/BUN K954000 Calcium K896224 Phosphate (Inorganic) ver.2 K…
Roche Diagnostic Systems, Inc.1995—
*K896224Cobas Ready Calcium Reagent
Summary page 2
…Reagent 510(k)# Urea/BUN K954000 Calcium K896224 Phosphate (Inorganic) ver.2 K883962 Siemens Healthcare Diagnostics AD…
Roche Diagnostic Systems, Inc.1990—
*K883962Roche Reagent for Inorganic Phosphorus
Summary page 2
…Urea/BUN K954000 Calcium K896224 Phosphate (Inorganic) ver.2 K883962 Siemens Healthcare Diagnostics ADVIA 1800/2400 reagent: Reagent…
Roche Diagnostic Systems, Inc.1988—
*K901229Chem 1 Clinical Analyzer (Method Urine Creatinine)
Summary page 2
…lthcare Diagnostics ADVIA 1800/2400 reagent: Reagent 510(k)#t Creatinine (CRE-2c) K90 1229 Verichemn Laboratories, Inc. standard: Reagent 5…
Technicon Instruments Corp.1990—
*K875285Multi-Chemistry Linearity Standard
Summary page 2
…Verichemn Laboratories, Inc. standard: Reagent 510(k)# Urine Chemistry Standard K875285 Device In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed to Descriptions: yiel…
Verichem Laboratories, Inc.1988—

Also cleared against K954000: 3 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)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2012Class IIZ-0743-2013Device DesignInorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K954000.

How does its category compare?

All CDN devices

CDN Urease, Photometric, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · CDN

1in 2019

2011: 12012: 12013: 22019: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CDN

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

Recalls per year · CDN

1in 2013

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

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

Adverse event reports per year · CDN

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2025

MAUDE reports naming product code CDN, 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
20090—00
20100—00
20111—00
20121—00
20132—10
20140—00
20150—02
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The ACE Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Calcium-Arsenazo Reagent is intended for the…

Read the full statement (292 words)

The ACE Urea Nitrogen Reagent is intended for the quantitative

determination of urea nitrogen concentration in urine using the

ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen

measurements are used in the diagnosis and treatment of certain

renal and metabolic diseases. This test is intended for use in

clinical laboratories or physician office laboratories. For in vitro

diagnostic use only.

The ACE Calcium-Arsenazo Reagent is intended for the

quantitative determination of calcium in urine using the ACE and

ACE Alera Clinical Chemistry Systems. Calcium measurements

are used in the diagnosis and treatment of parathyroid disease, a

variety of bone diseases, chronic renal disease and tetany. This test

is intended for use in clinical laboratories or physician office

laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative

determination of creatinine in urine using the ACE and ACE Alera

Clinical Chemistry Systems. Creatinine measurements are used in

the diagnosis and treatment of renal diseases, in monitoring renal

dialysis and as a calculation basis for measuring other urine

analytes. This test is intended for use in clinical laboratories or

physician office laboratories. For in vitro diagnostic use only.

The ACE Inorganic Phosphorus U.V. Reagent is intended for the

quantitative determination of inorganic phosphorus concentration

in urine using the ACE and ACE Alera Clinical Chemistry

Systems. Measurements of inorganic phosphorus are used in the

diagnosis and treatment of various disorders, including parathyroid

gland and kidney diseases and vitamin D imbalance. This test is

intended for use in clinical laboratories or physician office

laboratories. For in vitro diagnostic use only.

Alfa Wassermann Diagnostic Technologies, LLC ACE Urine

Standard is intended for the calibration of quantitative urine

reagents on Alfa Wassermann Clinical Chemistry Systems. For in

vitro diagnostic use only.

Indications for use as stated in the FDA summary.

Also cleared against K954000

3 other devices cite the same predicate.

  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
  • K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 20062 recalls
  • K981123UREATrace Scientific, Ltd. · 1998

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 CDN

The CDN category page

  • K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
  • K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc. · 2013
  • K123322Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentAlfa Wassermann Diagnostics Technologies, LLC · 2013
  • K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K001885Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1Ortho-Clinical Diagnostics, Inc. · 20002 recalls

https://510kreport.com/device/K103615 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103615: Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103615

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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