Cleared Traditional

K981734 - VTEC-RPLA SEIKEN

K981734 is an FDA 510(k) clearance for VTEC-RPLA SEIKEN, manufactured by Denka Seiken'S. The device is a Class 1 Microbiology device with product code GNA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K981734 · Denka Seiken'S · Microbiology device
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Sep 1998
Decision
127d
Days
Class 1
Risk

K981734 is an FDA 510(k) clearance for the VTEC-RPLA SEIKEN. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on September 22, 1998 after a review of 127 days - within the typical 510(k) review window.

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 Denka Seiken'S devices

FDA 510(k) Submission Details - K981734

510(k) Number K981734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date September 22, 1998
Days to Decision 127 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
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

GNA Device Classification - Class 1, General Controls

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 10
Devices cleared under the same product code (GNA) and FDA review panel - the closest regulatory comparables to K981734.
DUOPATH VEROTOXINS GLISA TEST
K031367 · Emd Chemicals, Inc. · Jan 2004
DRYSPOT E.COLI 0157 KIT
K993401 · Oxoid , Ltd. · Feb 2000
WELLCOLEX E-COLI OI57 ZC60
K962028 · Murex Diagnostics, Inc. · Nov 1996
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