Cleared Traditional

QUIX RAPID CHOLERA STRIP TEST (K954995) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954995 · Guardian Scientific, Corp. · Microbiology device
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Aug 1996
Decision
289d
Days
Class 2
Risk

K954995 is an FDA 510(k) clearance for the QUIX RAPID CHOLERA STRIP TEST. Classified as Antiserum, Vibrio Cholerae, All Varieties (product code GSQ), Class II - Special Controls.

Submitted by Guardian Scientific, Corp. (Columbia, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 289 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3930 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K954995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date August 15, 1996
Days to Decision 289 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 102d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GSQ Antiserum, Vibrio Cholerae, All Varieties
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3930
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 Microbiology devices follow this clearance model.