Cleared Traditional

K931151 - AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA

K931151 is an FDA 510(k) clearance for AFFIRM(TM) VPIII MICROBIAL IDENT TEST F..., manufactured by Microprobe Corp.. The device is a Class 1 Microbiology device with product code MLA cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K931151

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.

MLA Device Classification - Class 1, General Controls

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.