Cleared Traditional

TERUMO SENSIBEAD EIA FSH KIT (K863928) - FDA 510(k) Clearance

Class I Chemistry device.

K863928 · Terumo Medical Corp. · Chemistry device
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Dec 1986
Decision
57d
Days
Class 1
Risk

K863928 is an FDA 510(k) clearance for the TERUMO SENSIBEAD EIA FSH KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 57 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K863928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date December 04, 1986
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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 18
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K863928.
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · Ciba Corning Diagnostics Corp. · Dec 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · Bio-Rad · Jul 1983
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · Corning Medical & Scientific · Aug 1982