Cleared Traditional

K014259 - SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PN...

K014259 is the FDA 510(k) clearance for SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PN... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014259 · Trek Diagnostic Systems, Inc. · Microbiology device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014259 is an FDA 510(k) clearance for the SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 90 days - within the typical 510(k) review window.

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. 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 Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K014259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date March 26, 2002
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K014259.
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · Dade Microscan, Inc. · Apr 2002
ETEST ERTAPENEM
K020748 · Ab Biodisk · Apr 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · Dade Microscan, Inc. · Apr 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · Dade Microscan, Inc. · Mar 2002
PASCO MIC AND MIC/ID PANELS
K020331 · Pasco Laboratories, Inc. · Mar 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162 · Dade Behring, Inc. · Mar 2002