Cleared Traditional

K912698 - AFFINITY FREE T4 TEST SYSTEM

K912698 is an FDA 510(k) clearance for AFFINITY FREE T4 TEST SYSTEM, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K912698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Oct 1991
Decision
111d
Days
Class 2
Risk

K912698 is an FDA 510(k) clearance for the AFFINITY FREE T4 TEST SYSTEM. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K912698

510(k) Number K912698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date October 07, 1991
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 79
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K912698.
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SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · Serono-Baker Diagnostics, Inc. · Nov 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · Immunotech Corp. · Jun 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684 · Ciba Corning Diagnostics Corp. · May 1991
FLAGEN TM FREE T4
K904539 · Cyberfluor, Inc. · Nov 1990