Cleared Traditional

K123322 - ACE BUN/UREA REAGENT

K123322 is the FDA 510(k) clearance for ACE BUN/UREA REAGENT by Alfa Wassermann Diagnostics Technologies, LLC. It is a Class 2 Chemistry device (product code CDN) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K123322 · Alfa Wassermann Diagnostics Technologies, LLC · Chemistry device
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May 2013
Decision
207d
Days
Class 2
Risk

K123322 is an FDA 510(k) clearance for the ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK R.... Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on May 21, 2013 after a review of 207 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Wassermann Diagnostics Technologies, LLC devices

Submission Details

510(k) Number K123322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2012
Decision Date May 21, 2013
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDN Urease, Photometric, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDN Urease, Photometric, Urea Nitrogen

All 7
Devices cleared under the same product code (CDN) and FDA review panel - the closest regulatory comparables to K123322.
VITROS XT Chemistry Products UREA-CREA Slides
K190326 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885 · Ortho-Clinical Diagnostics, Inc. · Jul 2000
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · King Diagnostics, Inc. · Oct 1992
QUICKSTART UREA NITROGEN
K914903 · Em Diagnostic Systems, Inc. · Dec 1991
STATTEK BUN
K792328 · Boehringer Mannheim Corp. · Dec 1979
BUN (UREASE) REAGENT
K781253 · Coulter Electronics, Inc. · Aug 1978