Cleared Traditional

K946247 - IGFBP-3

Also marketed or referenced as:
INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3

K946247 is the FDA 510(k) clearance for IGFBP-3 by Nichols Institute. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K946247 · Nichols Institute · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
183d
Days
Class 1
Risk

K946247 is an FDA 510(k) clearance for the IGFBP-3. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on June 23, 1995 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute devices

Submission Details

510(k) Number K946247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date June 23, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 88d · This submission: 183d
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 22
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K946247.
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
K960551 · Diagnostic Systems Laboratories, Inc. · Mar 1996
IMMULITE HGH
K955376 · Diagnostic Products Corp. · Feb 1996
DSL ACTIVE IFGBP-3 ELISA
K951707 · Diagnostic Systems Laboratories, Inc. · May 1995
ACTIVE IGF-I ELISA
K951752 · Diagnostic Systems Laboratories, Inc. · May 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
K950228 · Diagnostic Systems Laboratories, Inc. · Feb 1995