Cleared Traditional

K981199 - MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO...

K981199 is the FDA 510(k) clearance for MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO... by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K981199 · Dade Microscan, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
230d
Days
Class 2
Risk

K981199 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 230 days - an extended review 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: 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 Microscan, Inc. devices

Submission Details

510(k) Number K981199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date November 18, 1998
Days to Decision 230 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
128d slower than avg
Panel avg: 102d · This submission: 230d
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 K981199.
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
K043545 · Dade Behring, Inc. · Feb 2005
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
K041150 · Dade Behring, Inc. · Jul 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · Dade Behring, Inc. · Mar 2004
SYNERGY SCREEN TEST, MODIFICATION
K921977 · Baxter Healthcare Corp · Oct 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · Baxter Diagnostics, Inc. · Mar 1993
WALKAWAY TM 40
K911400 · Baxter Healthcare Corp · Nov 1991