Cleared Traditional

K920536 - AFFIRM VP SAMPLE COLLECTION SET

K920536 is an FDA 510(k) clearance for AFFIRM VP SAMPLE COLLECTION SET, manufactured by Microprobe Corp.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K920536

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.

LIO Device Classification - Class 1, General Controls

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 36
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K920536.
ZINC PVA
K931383 · Remel Co. · Jun 1993
PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · Medical Laboratory Automation Systems, Inc. · Jan 1991