Cleared Traditional

K971402 - BARD BTA TRAK TEST

K971402 is an FDA 510(k) clearance for BARD BTA TRAK TEST, manufactured by Bard Diagnostic Sciences,Inc.. The device is a Class 2 Immunology device with product code MMW cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K971402 · Bard Diagnostic Sciences,Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
365d
Days
Class 2
Risk

K971402 is an FDA 510(k) clearance for the BARD BTA TRAK TEST. Classified as System, Test, Tumor Marker, Monitoring, Bladder (product code MMW), Class II - Special Controls.

Submitted by Bard Diagnostic Sciences,Inc. (Redmond, US). The FDA issued a Cleared decision on April 15, 1998 after a review of 365 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.

FDA 510(k) Submission Details - K971402

510(k) Number K971402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date April 15, 1998
Days to Decision 365 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
260d slower than avg
Panel avg: 105d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMW Device Classification - Class 2, Special Controls

Product Code MMW System, Test, Tumor Marker, Monitoring, Bladder
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 - MMW System, Test, Tumor Marker, Monitoring, Bladder

All 8
Devices cleared under the same product code (MMW) and FDA review panel - the closest regulatory comparables to K971402.
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K971402 · BARD BTA TRAK TEST
Download PDF FDA Summary Bard Diagnostic Scien…