Cleared Traditional

K946247 - IGFBP-3

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

K946247 is an FDA 510(k) clearance for IGFBP-3, manufactured by Nichols Institute. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K946247

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.

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 30
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
OCTEIA IGF-1 KIT
K950510 · Immunodiagnostic Systems , Ltd. · Apr 1995