Cleared Traditional

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (K931151) - FDA 510(k) Clearance

Class I Microbiology device.

K931151 · Microprobe Corp. · Microbiology device
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Jun 1993
Decision
102d
Days
Class 1
Risk

K931151 is an FDA 510(k) clearance for the AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA. Classified as Dna Probe, Yeast (product code MLA), Class I - General Controls.

Submitted by Microprobe Corp. (Bothell, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 102 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 K931151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 18, 1993
Days to Decision 102 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
At panel average
Panel avg: 102d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLA Dna Probe, Yeast
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.