Cleared Traditional

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST (K881142) - FDA 510(k) Clearance

Class I Chemistry device.

K881142 · Amersham Corp. · Chemistry device
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Jul 1988
Decision
126d
Days
Class 1
Risk

K881142 is an FDA 510(k) clearance for the AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Amersham Corp. devices

Submission Details

510(k) Number K881142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1988
Decision Date July 21, 1988
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 16
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K881142.
COAT-A-COUNT (TM) FSH IRMA
K893976 · Diagnostic Products Corp. · Aug 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987
TERUMO SENSIBEAD EIA FSH KIT
K863928 · Terumo Medical Corp. · Dec 1986
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985