Cleared Traditional

K111205 - MICROSCAN MICROSTREP PLUS PANELS

K111205 is the FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS PANELS by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K111205 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
82d
Days
Class 2
Risk

K111205 is an FDA 510(k) clearance for the MICROSCAN (R) MICROSTREP PLUS (R) PANELS. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 82 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K111205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date July 20, 2011
Days to Decision 82 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
20d faster than avg
Panel avg: 102d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 37
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K111205.
Thermo Scientific Sensititre ARIS HiQ System
K191914 · Thermo Fisher Scientific · Nov 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918 · Thermo Fisher Scientific · Nov 2019
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · Siemens Healthcare Diagnostics · Sep 2010
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
K081013 · Siemens Healthcare Diagnostics · Sep 2008
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
K071316 · Dade Behring, Inc. · Aug 2007