Cleared Traditional

K832307 - ONPG DISCS

K832307 is the FDA 510(k) clearance for ONPG DISCS by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832307 · Oxoid U.S.A., Inc. · Microbiology device
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Aug 1983
Decision
43d
Days
Class 1
Risk

K832307 is an FDA 510(k) clearance for the ONPG DISCS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 43 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K832307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1983
Decision Date August 26, 1983
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
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 147
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K832307.
BIO-UREA
K834029 · Remel Co. · Dec 1983
BACTROL GRAM SLIDE
K833901 · Difco Laboratories, Inc. · Dec 1983
RIME COLI KIT
K832587 · Austin Biological Laboratories · Oct 1983
SPS DISCS
K832305 · Oxoid U.S.A., Inc. · Aug 1983
BILE AESCULIN DISCS
K832306 · Oxoid U.S.A., Inc. · Aug 1983
OXY-SWAB
K831673 · Austin Biological Laboratories · Jun 1983