Cleared Traditional

K021997 - SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN...

K021997 is the FDA 510(k) clearance for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 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