Cleared Traditional

CHOLERA SMART(TM) (K932622) - FDA 510(k) Clearance

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

K932622 · New Horizons Diagnostics Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
756d
Days
Class 2
Risk

K932622 is an FDA 510(k) clearance for the CHOLERA SMART(TM). 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 June 27, 1995 after a review of 756 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all New Horizons Diagnostics Co. devices

Submission Details

510(k) Number K932622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1993
Decision Date June 27, 1995
Days to Decision 756 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
654d slower than avg
Panel avg: 102d · This submission: 756d
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.