Cleared Special

K023202 - MICROSCAN SYNERGIES PLUS

K023202 is the FDA 510(k) clearance for MICROSCAN SYNERGIES PLUS by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Special 510(k) pathway after a 28-day FDA review.

K023202 · Dade Microscan, Inc. · Microbiology device
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Oct 2002
Decision
28d
Days
Class 2
Risk

K023202 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS. 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 October 23, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dade Microscan, Inc. devices

Submission Details

510(k) Number K023202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2002
Decision Date October 23, 2002
Days to Decision 28 days
Submission Type Special
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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K023202.
PASCO MIC AND MIC/ID PANELS
K031205 · Pasco Laboratories, Inc. · Jun 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
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · Trek Diagnostic Systems, Inc. · Oct 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · Trek Diagnostic Systems, Inc. · Sep 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · Trek Diagnostic Systems, Inc. · Sep 2002