Cleared Traditional

K874303 - STAPHYLASE TEST

K874303 is an FDA 510(k) clearance for STAPHYLASE TEST, manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code LHT cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K874303 · Oxoid U.S.A., Inc. · Microbiology device
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Nov 1987
Decision
17d
Days
Class 1
Risk

K874303 is an FDA 510(k) clearance for the STAPHYLASE TEST. Classified as Staphylococcus Aureus Somatic Antigens (product code LHT), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3700 - 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

FDA 510(k) Submission Details - K874303

510(k) Number K874303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date November 06, 1987
Days to Decision 17 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
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

LHT Device Classification - Class 1, General Controls

Product Code LHT Staphylococcus Aureus Somatic Antigens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3700
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 - LHT Staphylococcus Aureus Somatic Antigens

All 10
Devices cleared under the same product code (LHT) and FDA review panel - the closest regulatory comparables to K874303.
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
K820531 · Meridian Diagnostics, Inc. · Apr 1982
STAPHYLOCOCCUS LATEX AGGLUTINATION KIT
K820683 · American Scientific Products · Apr 1982
ACCU-STAPH
K820347 · Carr-Scarborough Microbiologicals, Inc. · Mar 1982
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
K812367 · Dutchland Laboratories, Inc. · Sep 1981
RAT BLOOD IN ALSEVER'S, CITRATED
K812368 · Dutchland Laboratories, Inc. · Sep 1981
GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF
K812372 · Dutchland Laboratories, Inc. · Sep 1981