Cleared Traditional

K891385 - VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VI...

K891385 is the FDA 510(k) clearance for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VI... by Vitek Systems, Inc.. It is a Class 2 Chemistry device (product code DEW) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K891385 · Vitek Systems, Inc. · Chemistry device
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Apr 1989
Decision
40d
Days
Class 2
Risk

K891385 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS). Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 18, 1989 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 K891385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1989
Decision Date April 18, 1989
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Chemistry devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 54
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