Cleared Traditional

K072141 - S40 CLINICAL ANALYZER, S TEST IP, S TEST UA

K072141 is an FDA 510(k) clearance for S40 CLINICAL ANALYZER, manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K072141 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Jun 2008
Decision
327d
Days
Class 1
Risk

K072141 is an FDA 510(k) clearance for the S40 CLINICAL ANALYZER, S TEST IP, S TEST UA. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 24, 2008 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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 - K072141

510(k) Number K072141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date June 24, 2008
Days to Decision 327 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
239d slower than avg
Panel avg: 88d · This submission: 327d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

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