Cleared Special

K091949 - MICROSCAN MICROSTREP PLUS

K091949 is an FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Microbiology device with product code LTT cleared through the Special 510(k) pathway after a 209-day FDA review.

K091949 · Siemens Healthcare Diagnostics · Microbiology device
Download Printable Device Report (PDF)
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Jan 2010
Decision
209d
Days
Class 2
Risk

K091949 is an FDA 510(k) clearance for the MICROSCAN MICROSTREP PLUS, MODEL B1027-201. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on January 26, 2010 after a review of 209 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. 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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K091949

510(k) Number K091949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date January 26, 2010
Days to Decision 209 days
Submission Type Special
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
107d slower than avg
Panel avg: 102d · This submission: 209d
Pathway characteristics
Modification to existing cleared device.

LTT Device Classification - Class 2, Special Controls

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 45
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K091949.
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · Siemens Healthcare Diagnostics, Inc. · Jul 2015
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
MICROSCAN MICROSTEP
K111394 · Siemens Healthcare Diagnostics, Inc. · Jun 2011
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · Siemens Healthcare Diagnostics · Jul 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
K083262 · Siemens Healthcare Diagnostics · Feb 2009
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · Dade Behring, Inc. · Oct 2006