Cleared Traditional

K920952 - VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERR...

K920952 is the FDA 510(k) clearance for VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERR... by Vitek Systems, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K920952 · Vitek Systems, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
41d
Days
Class 2
Risk

K920952 is an FDA 510(k) clearance for the VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 7, 1992 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vitek Systems, Inc. devices

Submission Details

510(k) Number K920952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date April 07, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K920952.
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K931576 · Syva Co. · Aug 1993
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K924858 · Tosoh Medics, Inc. · Dec 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · Medix Biotech, Inc. · Jan 1992
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · Ciba Corning Diagnostics Corp. · Mar 1991
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · Medix Biotech, Inc. · Dec 1989