Cleared Traditional

K923579 - MINIVIDAS INSTRUMENT

K923579 is the FDA 510(k) clearance for MINIVIDAS INSTRUMENT by Biomerieux Vitek, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K923579 · Biomerieux Vitek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
207d
Days
Class 1
Risk

K923579 is an FDA 510(k) clearance for the MINIVIDAS INSTRUMENT. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 207 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K923579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date February 12, 1993
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

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