Cleared Traditional

K781662 - RIA

K781662 is the FDA 510(k) clearance for RIA by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K781662 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Nov 1978
Decision
41d
Days
Class 2
Risk

K781662 is an FDA 510(k) clearance for the RIA, T3 UPTAKE SOLID PHASE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 K781662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1978
Decision Date November 08, 1978
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 58
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K781662.
T-3 UPTAKE (MAA) KIT
K790461 · Amersham Corp. · May 1979
T3 UPTAKE KIT
K790417 · E. R. Squibb & Sons, Inc. · Apr 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · Kallestad Laboratories, Inc. · Jan 1979
CLINIRIA T-3 UPTAKE TEST
K781180 · Miles Laboratories, Inc. · Aug 1978
T-3 UPTAKE (SORBENT) KIT
K780525 · Amersham Corp. · May 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978