Cleared Traditional

K031367 - DUOPATH VEROTOXINS GLISA TEST

K031367 is the FDA 510(k) clearance for DUOPATH VEROTOXINS GLISA TEST by Emd Chemicals, Inc.. It is a Class 1 Microbiology device (product code GNA) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K031367 · Emd Chemicals, Inc. · Microbiology device
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Jan 2004
Decision
268d
Days
Class 1
Risk

K031367 is an FDA 510(k) clearance for the DUOPATH VEROTOXINS GLISA TEST. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 23, 2004 after a review of 268 days - an extended review 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: 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K031367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date January 23, 2004
Days to Decision 268 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 102d · This submission: 268d
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 K031367.
DRYSPOT E.COLI 0157 KIT
K993401 · Oxoid , Ltd. · Feb 2000
PREMIER EHEC
K953362 · Meridian Diagnostics, Inc. · Nov 1995
PREMIER EHEC
K950167 · Meridian Diagnostics, Inc. · Apr 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