Cleared Traditional

AFFIRM VP SAMPLE COLLECTION SET (K920536) - FDA 510(k) Clearance

Class I Microbiology device.

K920536 · Microprobe Corp. · Microbiology device
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Jul 1992
Decision
176d
Days
Class 1
Risk

K920536 is an FDA 510(k) clearance for the AFFIRM VP SAMPLE COLLECTION SET. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Microprobe Corp. (Bothell, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 176 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 K920536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date July 30, 1992
Days to Decision 176 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
74d slower than avg
Panel avg: 102d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 62
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