Cleared Traditional

K851259 - HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT

K851259 is an FDA 510(k) clearance for HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ..., manufactured by Nichols Institute Diagnostics. The device is a Class 1 Chemistry device with product code CFL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K851259 · Nichols Institute Diagnostics · Chemistry device
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May 1985
Decision
46d
Days
Class 1
Risk

K851259 is an FDA 510(k) clearance for the HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on May 13, 1985 after a review of 46 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 Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K851259

510(k) Number K851259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1985
Decision Date May 13, 1985
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
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 K851259.
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
K860228 · Boots-Celltech Diagnostics, Inc. · Feb 1986
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · Immuno Nuclear Corp. · Jun 1985
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · Nichols Institute Diagnostics · Oct 1984
HUMAN GROWTH HORMONE RIA KIT
K841094 · Diagnostic Products Corp. · May 1984
DAC-CEL HCG-MCA KIT RD52
K831073 · Wellcome Diagnostics · Sep 1983