Cleared Traditional

K970353 - AURA TEK FDP

K970353 is an FDA 510(k) clearance for AURA TEK FDP, manufactured by Perimmune, Inc.. The device is a Class 2 Immunology device with product code MMW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970353 · Perimmune, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
Class 2
Risk

K970353 is an FDA 510(k) clearance for the AURA TEK FDP. Classified as System, Test, Tumor Marker, Monitoring, Bladder (product code MMW), Class II - Special Controls.

Submitted by Perimmune, Inc. (Rockville, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Perimmune, Inc. devices

FDA 510(k) Submission Details - K970353

510(k) Number K970353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1997
Decision Date April 30, 1997
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
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

Devices cleared under the same product code (MMW) and FDA review panel - the closest regulatory comparables to K970353.
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
K203245 · Nucleix , Ltd. · May 2023
BTA STAT TEST PRESCRIPTION HOME USE
K974845 · Bard Diagnostic Sciences,Inc. · Dec 1998
BARD BTA TRAK TEST
K971402 · Bard Diagnostic Sciences,Inc. · Apr 1998
BARD AND BTA TEST
K964151 · Bard Diagnostic Sciences,Inc. · Apr 1997