Cleared Traditional

K072142 - S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

K072142 is an FDA 510(k) clearance for S40 CLINICAL ANALYZER, manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. The device is a Class 2 Chemistry device with product code CKF cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K072142 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Jun 2008
Decision
329d
Days
Class 2
Risk

K072142 is an FDA 510(k) clearance for the S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST. Classified as Phenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CKF), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 26, 2008 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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. Elevated predicate reliance profile. 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 - K072142

510(k) Number K072142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date June 26, 2008
Days to Decision 329 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
241d slower than avg
Panel avg: 88d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKF Device Classification - Class 2, Special Controls

Product Code CKF Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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.