Cleared Traditional

K021037 - MICROSTREP PLUS PANEL WITH AMPICILLIN

K021037 is an FDA 510(k) clearance for MICROSTREP PLUS PANEL WITH AMPICILLIN, manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K021037 · Dade Behring, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
35d
Days
Class 2
Risk

K021037 is an FDA 510(k) clearance for the MICROSTREP PLUS PANEL WITH AMPICILLIN. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on May 6, 2002 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

FDA 510(k) Submission Details - K021037

510(k) Number K021037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date May 06, 2002
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
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 403
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K021037.
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · Trek Diagnostic Systems, Inc. · May 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · Dade Behring, Inc. · May 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · Dade Microscan, Inc. · May 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
K020686 · Dade Microscan, Inc. · Apr 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · Dade Microscan, Inc. · Apr 2002
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