Cleared Traditional

MINI S.F.T. (URINE PRESERVATIVE) (K943466) - FDA 510(k) Clearance

Class I Chemistry device.

K943466 · Cambridge Diagnostic Products, Inc. · Chemistry device
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May 1995
Decision
343d
Days
Class 1
Risk

K943466 is an FDA 510(k) clearance for the MINI S.F.T. (URINE PRESERVATIVE). Classified as Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (product code LXG), Class I - General Controls.

Submitted by Cambridge Diagnostic Products, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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 Cambridge Diagnostic Products, Inc. devices

Submission Details

510(k) Number K943466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1994
Decision Date May 24, 1995
Days to Decision 343 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 88d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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.