Cleared Traditional

K863368 - SYPH-TRUST

K863368 is an FDA 510(k) clearance for SYPH-TRUST, manufactured by I.A.F. Production, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K863368 · I.A.F. Production, Inc. · Microbiology device
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Dec 1986
Decision
100d
Days
Class 2
Risk

K863368 is an FDA 510(k) clearance for the SYPH-TRUST. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by I.A.F. Production, Inc. (Quebec, Canada H7n4z9, CA). The FDA issued a Cleared decision on December 12, 1986 after a review of 100 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.

FDA 510(k) Submission Details - K863368

510(k) Number K863368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date December 12, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 102d · This submission: 100d
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 31
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K863368.
RSR CARD TEST
K871252 · Advanced Polymer Systems, Inc. · Aug 1987
SYPHILIS SEROLOGICAL REAGENTS
K871226 · New Horizons Diagnostics Co. · May 1987
OCEAN SCIENTIFIC VDRL TEST
K864731 · Ocean Scientific, Inc. · Mar 1987
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
K852751 · Preco, Inc. · Aug 1985
RAPID PLASMA REAGIN CARD TEST
K842541 · Clinical Sciences, Inc. · Jul 1984
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · Technicon Instruments Corp. · Mar 1984
K863368 · SYPH-TRUST
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