Cleared Traditional

K862813 - FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT

K862813 is the FDA 510(k) clearance for FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT by Serono Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K862813 · Serono Diagnostics, Inc. · Chemistry device
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Sep 1986
Decision
54d
Days
Class 1
Risk

K862813 is an FDA 510(k) clearance for the FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 54 days - a notably fast clearance cycle.

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: 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K862813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1986
Decision Date September 16, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
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 47
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K862813.
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · Hybritech, Inc. · Mar 1987
TERUMO SENSIBEAD EIA FSH KIT
K863928 · Terumo Medical Corp. · Dec 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · Nichols Institute Diagnostics · Oct 1986
DELFIA (TM) HFSH KIT
K862043 · Lkb Instruments, Inc. · Jun 1986
LEE-BEAD BETA FSH (EIA)
K854837 · Leeco Diagnostics, Inc. · Jan 1986
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985