Cleared Traditional

MICROSCAN MICROSTEP (K111394) - FDA 510(k) Clearance

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

K111394 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Jun 2011
Decision
35d
Days
Class 2
Risk

K111394 is an FDA 510(k) clearance for the MICROSCAN MICROSTEP. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on June 22, 2011 after a review of 35 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 K111394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2011
Decision Date June 22, 2011
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K111394.
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · Beckman Coulter, Inc. · Mar 2017
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 MICROSTREP PLUS PANEL, PENICILLIN
K062773 · Dade Behring, Inc. · Oct 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
K062777 · Dade Behring, Inc. · Oct 2006
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
K033940 · Dade Behring, Inc. · Feb 2004