Cleared Traditional

KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT (K102342) - FDA 510(k) Clearance

Class I Microbiology device.

K102342 · Microphage, Inc. · Microbiology device
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May 2011
Decision
260d
Days
Class 1
Risk

K102342 is an FDA 510(k) clearance for the KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT. Classified as Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt (product code OUS), Class I - General Controls.

Submitted by Microphage, Inc. (Longmont, US). The FDA issued a Cleared decision on May 5, 2011 after a review of 260 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2050 - 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 Microphage, Inc. devices

Submission Details

510(k) Number K102342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2010
Decision Date May 05, 2011
Days to Decision 260 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
158d slower than avg
Panel avg: 102d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OUS Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2050
Definition The Mrsa/mssa Blood Culture Test-bt Is A Qualitative Ivd Test Using Bacteriophage Amplification For The Identification Of Staphylococcus Aureus And The Determination Of Meca Mediated Methicillin Resistance Or Methicillin Susceptbility Directly From Positive Blood Cultures Confirmed To Have Gram Positive Cocci In Clusters (gpcc) Or Gram Positive Cocci In Singles (gpc) By Gram Stain.
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.