Cleared Traditional

K950167 - PREMIER EHEC

K950167 is the FDA 510(k) clearance for PREMIER EHEC by Meridian Diagnostics, Inc.. It is a Class 1 Microbiology device (product code GNA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K950167 · Meridian Diagnostics, Inc. · Microbiology device
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Apr 1995
Decision
87d
Days
Class 1
Risk

K950167 is an FDA 510(k) clearance for the PREMIER EHEC. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - 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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K950167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date April 14, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNA Antisera, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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 - GNA Antisera, All Types, Escherichia Coli

All 7
Devices cleared under the same product code (GNA) and FDA review panel - the closest regulatory comparables to K950167.
DUOPATH VEROTOXINS GLISA TEST
K031367 · Emd Chemicals, Inc. · Jan 2004
DRYSPOT E.COLI 0157 KIT
K993401 · Oxoid , Ltd. · Feb 2000
PREMIER EHEC
K953362 · Meridian Diagnostics, Inc. · Nov 1995
RIM E.COLI 0157:H7 LATEX TEST
K933457 · Remel Co. · Apr 1994
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
K884026 · Oxoid U.S.A., Inc. · Feb 1989
PHADEBACT ETEC-LT TEST
K874288 · Pharmacia, Inc. · Sep 1988