Cleared Traditional

K962966 - IDS RAPID CB PLUS SYSTEM

K962966 is the FDA 510(k) clearance for IDS RAPID CB PLUS SYSTEM by Innovative Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K962966 · Innovative Diagnostic Systems, Inc. · Microbiology device
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Oct 1996
Decision
70d
Days
Class 1
Risk

K962966 is an FDA 510(k) clearance for the IDS RAPID CB PLUS SYSTEM. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Innovative Diagnostic Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 70 days - a notably fast clearance cycle.

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: 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 Innovative Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K962966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date October 08, 1996
Days to Decision 70 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
32d faster than avg
Panel avg: 102d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
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.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 148
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K934986 · Remel Co. · Feb 1994