Cleared Traditional

K964151 - BARD AND BTA TEST

K964151 is an FDA 510(k) clearance for BARD AND BTA 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 197-day FDA review.

K964151 · Bard Diagnostic Sciences,Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
197d
Days
Class 2
Risk

K964151 is an FDA 510(k) clearance for the BARD AND BTA 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 16, 1997 after a review of 197 days - an extended review cycle.

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. Standard predicate reliance. 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 Bard Diagnostic Sciences,Inc. devices

FDA 510(k) Submission Details - K964151

510(k) Number K964151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date April 16, 1997
Days to Decision 197 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
92d slower than avg
Panel avg: 105d · This submission: 197d
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.