Cleared Traditional

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. (K861920) - FDA 510(k) Clearance

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

K861920 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jun 1986
Decision
28d
Days
Class 2
Risk

K861920 is an FDA 510(k) clearance for the SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 K861920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1986
Decision Date June 16, 1986
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 69
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K861920.
TSH MAB IRMA
K864839 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · American Dade · Aug 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · Terumo Medical Corp. · Jun 1986
ECHOCLONAL HTSH IRMA
K860288 · Bio-Rad · Apr 1986
TSH-IRMA COAT-A-COUNT KIT
K860054 · Diagnostic Products Corp. · Mar 1986
TERUMO SENSIBEAD EIA TSH KIT
K850376 · Terumo Medical Corp. · Mar 1985