Cleared Traditional

K851259 - HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ...

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

K851259 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 21
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K851259.
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
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · Nichols Institute Diagnostics · Oct 1984
HUMAN GROWTH HORMONE RIA KIT
K841094 · Diagnostic Products Corp. · May 1984
TANDEM - HGH KIT
K821366 · Hybritech, Inc. · Jun 1982