Cleared Traditional

K011400 - MRSA-SCREEN

K011400 is an FDA 510(k) clearance for MRSA-SCREEN, manufactured by Denka Seiken'S. The device is a Class 2 Microbiology device with product code MYI cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K011400 · Denka Seiken'S · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
324d
Days
Class 2
Risk

K011400 is an FDA 510(k) clearance for the MRSA-SCREEN. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on March 27, 2002 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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. Elevated predicate reliance profile. 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 - K011400

510(k) Number K011400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date March 27, 2002
Days to Decision 324 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 102d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYI Device Classification - Class 2, Special Controls

Product Code MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

All 7
Devices cleared under the same product code (MYI) and FDA review panel - the closest regulatory comparables to K011400.
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · Binax, Inc. · Apr 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766 · Binax, Inc. · Feb 2010
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · Oxoid , Ltd. · Apr 2002
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640 · Id Biomedical Corp. · Jul 1999