Cleared Traditional

K905163 - NITRATE DISK

K905163 is the FDA 510(k) clearance for NITRATE DISK by Remel Co.. It is a Class 1 Microbiology device (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

Submission Details

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.

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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K905163.
BACTIDROP(TM) SPOT INDOLE
K913004 · Remel Co. · Sep 1991
BACTIDROP(TM) INDOLE (KOVACS)
K913009 · Remel Co. · Sep 1991
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 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