Cleared Traditional

K111205 - MICROSCAN (R) MICROSTREP PLUS (R) PANELS (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111205 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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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
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.