Cleared Traditional

K905163 - NITRATE DISK

K905163 is an FDA 510(k) clearance for NITRATE DISK, manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K905163 · Remel Co. · Microbiology device
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Feb 1991
Decision
96d
Days
Class 1
Risk

K905163 is an FDA 510(k) clearance for the NITRATE DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on February 20, 1991 after a review of 96 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 Remel Co. devices

FDA 510(k) Submission Details - K905163

510(k) Number K905163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1990
Decision Date February 20, 1991
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K905163.
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1991
LAP DISCS
K905472 · Carr-Scarborough Microbiologicals, Inc. · Feb 1991
M. CAT. BUTYRATE DISC
K905666 · Carr-Scarborough Microbiologicals, Inc. · Feb 1991
VANCOMYCIN DISK-5 MCG
K905151 · Remel Co. · Jan 1991
CATARRHALIS TEST STRIP
K902595 · Remel Co. · Oct 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · Difco Laboratories, Inc. · Jun 1990