Cleared Traditional

RAPID NFT, MODIFICATION (K922768) - FDA 510(k) Clearance

Class I Microbiology device.

K922768 · Biomerieux Vitek, Inc. · Microbiology device
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Oct 1992
Decision
128d
Days
Class 1
Risk

K922768 is an FDA 510(k) clearance for the RAPID NFT, MODIFICATION. Classified as Kit, Identification, Glucose Nonfermenter (product code JSW), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K922768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date October 14, 1992
Days to Decision 128 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 102d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSW Kit, Identification, Glucose Nonfermenter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.