Cleared Traditional

K863929 - TERUMO SENSIBEAD(TM) EIA HLH KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K863929 · Terumo Medical Corp. · Chemistry device
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Nov 1986
Decision
36d
Days
Class 1
Risk

K863929 is an FDA 510(k) clearance for the TERUMO SENSIBEAD(TM) EIA HLH KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on November 13, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 K863929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date November 13, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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.