Cleared Traditional

K896808 - IGF-I BY EXTRACTION

Also marketed or referenced as:
INSULIN-LIKE GROWTH FACTOR I

K896808 is the FDA 510(k) clearance for IGF-I BY EXTRACTION 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.

K896808 · Nichols Institute Diagnostics · Chemistry device
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Jan 1990
Decision
46d
Days
Class 1
Risk

K896808 is an FDA 510(k) clearance for the IGF-I BY EXTRACTION. 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 January 19, 1990 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 K896808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date January 19, 1990
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 K896808.
DSL IGFBP-3 RIA (DSL 6700)
K930047 · Diagnostic Systems Laboratories, Inc. · Jul 1994
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · Medix Biotech, Inc. · Mar 1992
AIA-PACK HGH
K905757 · Tosoh Medics, Inc. · Jan 1991
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