Cleared Traditional

K852299 - TERUMO SENSIBEAD EIA HGH KIT

K852299 is an FDA 510(k) clearance for TERUMO SENSIBEAD EIA HGH KIT, manufactured by Terumo Medical Corp.. The device is a Class 1 Chemistry device with product code CFL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K852299 · Terumo Medical Corp. · Chemistry device
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Jul 1985
Decision
41d
Days
Class 1
Risk

K852299 is an FDA 510(k) clearance for the TERUMO SENSIBEAD EIA HGH KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1370 - 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

FDA 510(k) Submission Details - K852299

510(k) Number K852299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 09, 1985
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

CFL Device Classification - Class 1, General Controls

Product Code CFL Radioimmunoassay, Human Growth Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1370
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 - CFL Radioimmunoassay, Human Growth Hormone

All 25
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K852299.
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · Medix Biotech, Inc. · Dec 1989
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · Diagnostic Systems Laboratories, Inc. · Jul 1988
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · Immuno Nuclear Corp. · Jun 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · Nichols Institute Diagnostics · May 1985
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · Nichols Institute Diagnostics · Oct 1984