Cleared Traditional

K101425 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO...

K101425 is an FDA 510(k) clearance for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Microbiology device with product code LRG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K101425 · Siemens Healthcare Diagnostics · Microbiology device
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Sep 2010
Decision
113d
Days
Class 2
Risk

K101425 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K101425

510(k) Number K101425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date September 10, 2010
Days to Decision 113 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
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRG Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K101425.
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K111677 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
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K111205 · Siemens Healthcare Diagnostics, Inc. · Jul 2011
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
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299 · Dade Behring, Inc. · Nov 2006