Cleared Traditional

K113389 - ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT

K113389 is an FDA 510(k) clearance for ACE CK REAGENT, manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. The device is a Class 2 Chemistry device with product code CDN cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K113389 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
268d
Days
Class 2
Risk

K113389 is an FDA 510(k) clearance for the ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 268 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 Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K113389

510(k) Number K113389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date August 10, 2012
Days to Decision 268 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
180d slower than avg
Panel avg: 88d · This submission: 268d
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 K113389.
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