Cleared Traditional

K965141 - TRUQUANT BR RIA

K965141 is an FDA 510(k) clearance for TRUQUANT BR RIA, manufactured by Biomira USA, Inc.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K965141 · Biomira USA, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
312d
Days
Class 2
Risk

K965141 is an FDA 510(k) clearance for the TRUQUANT BR RIA. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Biomira USA, Inc. (Cranberry, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomira USA, Inc. devices

FDA 510(k) Submission Details - K965141

510(k) Number K965141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date October 31, 1997
Days to Decision 312 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 105d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOI Device Classification - Class 2, Special Controls

Product Code MOI System, Test, Immunological, Antigen, Tumor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 Immunology devices follow this clearance model.

Regulatory Peers - MOI System, Test, Immunological, Antigen, Tumor

All 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K965141.
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
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THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · Bayer Corp. · Dec 1997
IMX CA 15-3
K964407 · Abbott Laboratories · Nov 1997
AXSYM CA 15-3
K963926 · Abbott Laboratories · Sep 1997
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K970695 · Chiron Diagnostics Corp. · Aug 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · Chiron Diagnostics Corp. · Jul 1997