Cleared Traditional

K032706 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO...

K032706 is the FDA 510(k) clearance for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO... by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K032706 · Dade Behring, Inc. · Microbiology device
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Feb 2004
Decision
161d
Days
Class 2
Risk

K032706 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on February 10, 2004 after a review of 161 days - an extended review 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: 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K032706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date February 10, 2004
Days to Decision 161 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
59d slower than avg
Panel avg: 102d · This submission: 161d
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 314
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K032706.
PASCO MIC AND MIC/ID PANELS
K041214 · Pasco Laboratories, Inc. · Jun 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · Trek Diagnostic Systems, Inc. · Apr 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · Trek Diagnostic Systems, Inc. · Apr 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · Trek Diagnostic Systems, Inc. · Feb 2004
PASCO MIC AND MIC/ID PANELS
K033119 · Pasco Laboratories, Inc. · Nov 2003
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · Trek Diagnostic Systems, Inc. · Aug 2003