Cleared Traditional

AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (K922457) - FDA 510(k) Clearance

Class I Microbiology device.

K922457 · Microprobe Corp. · Microbiology device
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Sep 1992
Decision
122d
Days
Class 1
Risk

K922457 is an FDA 510(k) clearance for the AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA. Classified as Dna Probe, Trichomonas Vaginalis (product code MJK), Class I - General Controls.

Submitted by Microprobe Corp. (Bothell, US). The FDA issued a Cleared decision on September 25, 1992 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Microprobe Corp. devices

Submission Details

510(k) Number K922457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date September 25, 1992
Days to Decision 122 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
20d slower than avg
Panel avg: 102d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJK Dna Probe, Trichomonas Vaginalis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.