Cleared Traditional

K974027 - AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

K974027 is an FDA 510(k) clearance for AURAFLEX FT3 150 TEST PACK, manufactured by Alfa Biotech (Uk) , Ltd.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K974027 · Alfa Biotech (Uk) , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
102d
Days
Class 2
Risk

K974027 is an FDA 510(k) clearance for the AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Alfa Biotech (Uk) , Ltd. (Aldershot, GB). The FDA issued a Cleared decision on February 2, 1998 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Biotech (Uk) , Ltd. devices

FDA 510(k) Submission Details - K974027

510(k) Number K974027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1997
Decision Date February 02, 1998
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 118
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