Cleared Traditional

SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY (K853628) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Sep 1985
Decision
20d
Days
Class 2
Risk

K853628 is an FDA 510(k) clearance for the SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 20 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 K853628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1985
Decision Date September 18, 1985
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 40
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K853628.
IQ FTI IMMUNOASSAY
K865104 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
IQ FREE T4 IMMUNOASSAY
K864658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
SIMULTRAC FREE T4[57CO]/TSH MAB[125I]
K864838 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
K823264 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN
K822882 · Diagnostic Products Corp. · Nov 1982
TRIOBEAD-125 DIAGNOSTIC KIT
K771236 · Abbott Laboratories · Aug 1977