Cleared Traditional

K862946 - OXOID SIGNAL BLOOD CULTURE SYSTEM

K862946 is an FDA 510(k) clearance for OXOID SIGNAL BLOOD CULTURE SYSTEM, manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K862946 · Oxoid U.S.A., Inc. · Microbiology device
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Nov 1986
Decision
92d
Days
Class 1
Risk

K862946 is an FDA 510(k) clearance for the OXOID SIGNAL BLOOD CULTURE SYSTEM. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Hampshire Rg 24 Op, GB). The FDA issued a Cleared decision on November 5, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Oxoid U.S.A., Inc. devices

FDA 510(k) Submission Details - K862946

510(k) Number K862946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date November 05, 1986
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

JSG Device Classification - Class 1, General Controls

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 189
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K862946.
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CHARCOAL AGAR BASE
K861480 · Gibco Laboratories Life Technologies, Inc. · May 1986
BIOTIS TSA
K860397 · Otisville Biotech, Inc. · Feb 1986
BIOTIS TODD HEWITT BROTH
K860399 · Otisville Biotech, Inc. · Feb 1986