Cleared Traditional

K043589 - MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO...

K043589 is the FDA 510(k) clearance for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO... by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K043589 · Dade Microscan, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
48d
Days
Class 2
Risk

K043589 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on February 14, 2005 after a review of 48 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 Dade Microscan, Inc. devices

Submission Details

510(k) Number K043589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date February 14, 2005
Days to Decision 48 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
54d faster than avg
Panel avg: 102d · This submission: 48d
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 K043589.
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
K052366 · Ab Biodisk · Oct 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · Trek Diagnostic Systems, Inc. · Sep 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · Dade Behring, Inc. · Jun 2005
DAPTOMYCIN
K042392 · Ab Biodisk · Dec 2004
ETEST FOR GEMIFLOXACIN
K042390 · Ab Biodisk · Nov 2004
PASCO MIC AND MIC/ID PANELS
K042331 · Pasco Laboratories, Inc. · Oct 2004