Cleared Traditional

DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT (K931922) - FDA 510(k) Clearance

Class I Microbiology device.

K931922 · Viratest Intl., Inc. · Microbiology device
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Mar 1994
Decision
348d
Days
Class 1
Risk

K931922 is an FDA 510(k) clearance for the DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Viratest Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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. Elevated predicate reliance profile. 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 Viratest Intl., Inc. devices

Submission Details

510(k) Number K931922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date March 30, 1994
Days to Decision 348 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 102d · This submission: 348d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 110
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