Cleared Traditional

CHOLERASCREEN (K922432) - FDA 510(k) Clearance

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

K922432 · New Horizons Diagnostics Co. · Microbiology device
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Dec 1992
Decision
199d
Days
Class 2
Risk

K922432 is an FDA 510(k) clearance for the CHOLERASCREEN. Classified as Antiserum, Vibrio Cholerae, All Varieties (product code GSQ), Class II - Special Controls.

Submitted by New Horizons Diagnostics Co. (Columbia, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 199 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.

View all New Horizons Diagnostics Co. devices

Submission Details

510(k) Number K922432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date December 07, 1992
Days to Decision 199 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
97d slower than avg
Panel avg: 102d · This submission: 199d
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.