Cleared Traditional

K883971 - QLIA T UPTAKE ASSAY

K883971 is the FDA 510(k) clearance for QLIA T UPTAKE ASSAY by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K883971 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Oct 1988
Decision
35d
Days
Class 2
Risk

K883971 is an FDA 510(k) clearance for the QLIA T UPTAKE ASSAY. 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 25, 1988 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K883971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date October 25, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 66
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K883971.
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DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · Sclavo, Inc. · Sep 1987
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · American Dade · Mar 1987
IQ FTI IMMUNOASSAY
K865104 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987