Cleared Traditional

K983408 - DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K983408 is an FDA 510(k) clearance for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M..., manufactured by Dade Microscan, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K983408 · Dade Microscan, Inc. · Microbiology device
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May 1999
Decision
224d
Days
Class 2
Risk

K983408 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS. 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 May 10, 1999 after a review of 224 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

FDA 510(k) Submission Details - K983408

510(k) Number K983408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1998
Decision Date May 10, 1999
Days to Decision 224 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
122d slower than avg
Panel avg: 102d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K983408.
PASCO MIC AND MIC/ID PANELS
K992059 · Pasco Laboratories, Inc. · Aug 1999
PASCO MIC AND MIC/ID PANELS
K991925 · Pasco Laboratories, Inc. · Aug 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983922 · Dade Microscan, Inc. · Jun 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983711 · Dade Microscan, Inc. · Apr 1999
ETEST FOR CEFUROXIME
K990722 · Ab Biodisk · Apr 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · Ab Biodisk · Mar 1999