Cleared Traditional

K983746 - MICROSTREP PLUS PANEL

K983746 is the FDA 510(k) clearance for MICROSTREP PLUS PANEL by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K983746 · Dade Microscan, Inc. · Microbiology device
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Dec 1999
Decision
412d
Days
Class 2
Risk

K983746 is an FDA 510(k) clearance for the MICROSTREP PLUS PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on December 9, 1999 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Dade Microscan, Inc. devices

Submission Details

510(k) Number K983746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1998
Decision Date December 09, 1999
Days to Decision 412 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
310d slower than avg
Panel avg: 102d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test 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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K983746.
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · Dade Microscan, Inc. · Feb 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · Dade Microscan, Inc. · Jan 2000
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
K993679 · Dade Microscan, Inc. · Jan 2000
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
K992296 · Pasco Laboratories, Inc. · Sep 1999
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
K992143 · Pasco Laboratories, Inc. · Sep 1999
PASCO MIC AND MIC/ID PANELS (CEFEPIME)
K992108 · Pasco Laboratories, Inc. · Sep 1999