Cleared Traditional

K031205 - PASCO MIC AND MIC/ID PANELS

K031205 is the FDA 510(k) clearance for PASCO MIC AND MIC/ID PANELS by Pasco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K031205 · Pasco Laboratories, Inc. · Microbiology device
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Jun 2003
Decision
58d
Days
Class 2
Risk

K031205 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pasco Laboratories, Inc. devices

Submission Details

510(k) Number K031205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date June 13, 2003
Days to Decision 58 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
44d faster than avg
Panel avg: 102d · This submission: 58d
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 K031205.
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · Trek Diagnostic Systems, Inc. · Aug 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
K031727 · Pasco Laboratories, Inc. · Jul 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · Trek Diagnostic Systems, Inc. · Jul 2003
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
K031103 · Pasco Laboratories, Inc. · Jun 2003
PASCO MIC AND MIC/ID PANELS
K030933 · Pasco Laboratories, Inc. · May 2003
MICROSCAN SYNERGIES PLUS
K023202 · Dade Microscan, Inc. · Oct 2002