Cleared Traditional

K032706 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML

K032706 is an FDA 510(k) clearance for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO..., manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K032706

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.

JWY Device Classification - Class 2, Special Controls

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 403
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