Cleared Special

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092919 · Siemens Healthcare Diagnostics · Microbiology device
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Oct 2009
Decision
30d
Days
Class 2
Risk

K092919 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K092919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2009
Decision Date October 23, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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