Cleared Traditional

K860228 - SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA

K860228 is an FDA 510(k) clearance for SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA, manufactured by Boots-Celltech Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CFL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K860228 · Boots-Celltech Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
37d
Days
Class 1
Risk

K860228 is an FDA 510(k) clearance for the SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on February 28, 1986 after a review of 37 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 Boots-Celltech Diagnostics, Inc. devices

FDA 510(k) Submission Details - K860228

510(k) Number K860228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date February 28, 1986
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 29
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K860228.
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · Medix Biotech, Inc. · Dec 1989
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · Cyberfluor, Inc. · Aug 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · Diagnostic Systems Laboratories, Inc. · Jul 1988
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · Immuno Nuclear Corp. · Jun 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · Nichols Institute Diagnostics · May 1985