Cleared Traditional

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972772 · Trek Diagnostic Systems, Inc. · Microbiology device
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Jul 1999
Decision
719d
Days
Class 2
Risk

K972772 is an FDA 510(k) clearance for the ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING. Classified as Susceptibility Test Powders, Antimycobacterial (product code MJA), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on July 13, 1999 after a review of 719 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 Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K972772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date July 13, 1999
Days to Decision 719 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
617d slower than avg
Panel avg: 102d · This submission: 719d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJA Susceptibility Test Powders, Antimycobacterial
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.