Cleared Traditional

AMERLEX-M FREE T-3 RIA (K842949) - FDA 510(k) Clearance

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

K842949 · Amersham Corp. · Chemistry device
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Sep 1984
Decision
61d
Days
Class 2
Risk

K842949 is an FDA 510(k) clearance for the AMERLEX-M FREE T-3 RIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Amersham Corp. (Walker, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Amersham Corp. devices

Submission Details

510(k) Number K842949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date September 05, 1984
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 39
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K842949.
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · Baxter Healthcare Corp · Oct 1988
ABBOTT IMX T3
K880087 · Abbott Laboratories · Apr 1988
TDX TOTAL T3
K851676 · Abbott Laboratories · May 1985
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
SOPHEIA T3 EIA KIT
K840050 · Diagnostic Products Corp. · Mar 1984
COAT-A-COUNT FREE T3 RIA KIT
K832164 · Diagnostic Products Corp. · Oct 1983