Cleared Traditional

K071316 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN

K071316 is an FDA 510(k) clearance for MICROSCAN SYNERGIES PLUS GRAM POSITIVE ..., manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with product code LRG cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K071316 · Dade Behring, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
102d
Days
Class 2
Risk

K071316 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STR.... Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on August 20, 2007 after a review of 102 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K071316

510(k) Number K071316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2007
Decision Date August 20, 2007
Days to Decision 102 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
At panel average
Panel avg: 102d · This submission: 102d
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 41
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K071316.
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · Siemens Healthcare Diagnostics, Inc. · Jul 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 MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299 · Dade Behring, Inc. · Nov 2006
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
K063102 · Dade Behring, Inc. · Nov 2006
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
K063099 · Dade Behring, Inc. · Nov 2006