Cleared Traditional

K123322 - ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

K123322 is an FDA 510(k) clearance for ACE BUN/UREA REAGENT, manufactured by Alfa Wassermann Diagnostics Technologies, LLC. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K123322

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
Combination Product No
PCCP Authorized No
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.

CDN Device Classification - Class 2, Special Controls

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 15
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
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S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
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K113389 · Alfa Wassermann Diagnostic Technologies, Inc. · Aug 2012
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K103615 · Alfa Wassermann Diagnostic Technologies, Inc. · Sep 2011
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885 · Ortho-Clinical Diagnostics, Inc. · Jul 2000
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · Cholestech Corp. · Jul 1997