Cleared Traditional

K833654 - IDS RAPID STR SYSTEM

K833654 is an FDA 510(k) clearance for IDS RAPID STR SYSTEM, manufactured by Innovative Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K833654 · Innovative Diagnostic Systems, Inc. · Microbiology device
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Feb 1984
Decision
116d
Days
Class 1
Risk

K833654 is an FDA 510(k) clearance for the IDS RAPID STR SYSTEM. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 116 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 Innovative Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K833654

510(k) Number K833654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1983
Decision Date February 13, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 102d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 197
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K833654.
SPOTTEST NITRATE REAGENT C
K840581 · Difco Laboratories, Inc. · Feb 1984
SPOTTEST FERRIC CHLORIDE REAGENT
K840582 · Difco Laboratories, Inc. · Feb 1984
SPOTTEST VOGES-PROSKAUER REAGENT B
K840583 · Difco Laboratories, Inc. · Feb 1984
DIFFERENTIATION DISKS HIPPURATE
K834581 · Difco Laboratories, Inc. · Feb 1984
HAEMOPHILUS IDENTIFICATION TEST KIT
K833963 · Remel Co. · Dec 1983
PVP IODINE
K834022 · Remel Co. · Dec 1983