Cleared Traditional

K021997 - SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K021997 is an FDA 510(k) clearance for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN..., manufactured by Trek Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K021997 · Trek Diagnostic Systems, Inc. · Microbiology device
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Sep 2002
Decision
98d
Days
Class 2
Risk

K021997 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on September 25, 2002 after a review of 98 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 Trek Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K021997

510(k) Number K021997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2002
Decision Date September 25, 2002
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
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 K021997.
PASCO MIC AND MIC/ID PANELS
K030933 · Pasco Laboratories, Inc. · May 2003
MICROSCAN SYNERGIES PLUS
K023202 · Dade Microscan, Inc. · Oct 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · Trek Diagnostic Systems, Inc. · Oct 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · Trek Diagnostic Systems, Inc. · Sep 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · Trek Diagnostic Systems, Inc. · Jun 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181 · Dade Microscan, Inc. · Jun 2002