Cleared Traditional

AMERLEX-M TSH RIA (K842948) - FDA 510(k) Clearance

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

K842948 · Amersham Corp. · Chemistry device

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Sep 1984

Decision

40d

Days

Class 2

Risk

K842948 is an FDA 510(k) clearance for the AMERLEX-M TSH RIA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 40 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 Amersham Corp. devices

Submission Details

510(k) Number	K842948 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 26, 1984
Decision Date	September 04, 1984
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

48d faster than avg

Panel avg: 88d · This submission: 40d

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 70

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K842948.

TSH-IRMA COAT-A-COUNT KIT

K860054 · Diagnostic Products Corp. · Mar 1986

TERUMO SENSIBEAD EIA TSH KIT

K850376 · Terumo Medical Corp. · Mar 1985

ABBOTT HTSH EIA DIAGNOSTIC KIT

K843540 · Abbott Laboratories · Nov 1984

BLOOD SPOT NEONATAL TSH RADIOIMMUNO

K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1984

EPSILON TSH TEST KIT

K831972 · Beckman Instruments, Inc. · Sep 1983

HISH EIA DIAGNOSTIC KIT

K822827 · Abbott Laboratories · Oct 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842948

Amersham Corp.

Mchenry, IL · US

Regulatory profile

94 submissions 94 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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