Cleared Traditional

K922457 - AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

K922457 is an FDA 510(k) clearance for AFFIRM VP MICROBIAL ID TEST FOR TRICHOM..., manufactured by Microprobe Corp.. The device is a Class 1 Microbiology device with product code MJK cleared through the Traditional 510(k) pathway after a 122-day FDA review.

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

FDA 510(k) Submission Details - K922457

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.

MJK Device Classification - Class 1, General Controls

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.