Cleared Traditional

K943466 - MINI S.F.T. (URINE PRESERVATIVE)

K943466 is an FDA 510(k) clearance for MINI S.F.T. (URINE PRESERVATIVE), manufactured by Cambridge Diagnostic Products, Inc.. The device is a Class 1 Chemistry device with product code LXG cleared through the Traditional 510(k) pathway after a 343-day FDA review.

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

FDA 510(k) Submission Details - K943466

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.

LXG Device Classification - Class 1, General Controls

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.