Cleared Traditional

K954994 - TRUST

K954994 is an FDA 510(k) clearance for TRUST, manufactured by Guardian Scientific, Corp.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K954994 · Guardian Scientific, Corp. · Microbiology device
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Oct 1996
Decision
353d
Days
Class 2
Risk

K954994 is an FDA 510(k) clearance for the TRUST. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Guardian Scientific, Corp. (Columbia, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - 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. Elevated predicate reliance profile. 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 Guardian Scientific, Corp. devices

FDA 510(k) Submission Details - K954994

510(k) Number K954994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date October 18, 1996
Days to Decision 353 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
251d slower than avg
Panel avg: 102d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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 - GMQ Antigens, Nontreponemal, All

All 18
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