Cleared Traditional

K991810 - MODIFICATION TO SENSITITRE YEASTONE MIC...

K991810 is the FDA 510(k) clearance for MODIFICATION TO SENSITITRE YEASTONE MIC... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code NGZ) cleared through the Traditional 510(k) pathway after a 866-day FDA review.

K991810 · Trek Diagnostic Systems, Inc. · Microbiology device
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Oct 2001
Decision
866d
Days
Class 2
Risk

K991810 is an FDA 510(k) clearance for the MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST. Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 866 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 K991810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date October 09, 2001
Days to Decision 866 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
764d slower than avg
Panel avg: 102d · This submission: 866d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGZ Susceptibility Test Plate, Antifungal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.
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.