Cleared Traditional

K881142 - AMERLITE FSH ASSAY

K881142 is an FDA 510(k) clearance for AMERLITE FSH ASSAY, manufactured by Amersham Corp.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K881142

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

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 54
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K881142.
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · Binax, Inc. · Oct 1988
PHASE II FSH KIT
K883279 · Vitek Systems, Inc. · Sep 1988
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
K881596 · Medix Biotech, Inc. · May 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · Nichols Institute Diagnostics · Apr 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987