Cleared Traditional

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (K000687) - FDA 510(k) Clearance

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

K000687 · Beacon Biologicals, Inc. · Microbiology device
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Jun 2000
Decision
104d
Days
Class 2
Risk

K000687 is an FDA 510(k) clearance for the THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Beacon Biologicals, Inc. (Boca Raton, US). The FDA issued a Cleared decision on June 12, 2000 after a review of 104 days - within the typical 510(k) review window.

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. 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 Beacon Biologicals, Inc. devices

Submission Details

510(k) Number K000687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date June 12, 2000
Days to Decision 104 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
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
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