Cleared Traditional

K862946 - OXOID SIGNAL BLOOD CULTURE SYSTEM

K862946 is the FDA 510(k) clearance for OXOID SIGNAL BLOOD CULTURE SYSTEM by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (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

Submission Details

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.

Device Classification

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 175
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