Cleared Traditional

K921868 - ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADI...

K921868 is the FDA 510(k) clearance for ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADI... by Endocrine Sciences Products. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 623-day FDA review.

K921868 · Endocrine Sciences Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
623d
Days
Class 1
Risk

K921868 is an FDA 510(k) clearance for the ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Endocrine Sciences Products (Calabasas, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 623 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Endocrine Sciences Products devices

Submission Details

510(k) Number K921868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1992
Decision Date January 03, 1994
Days to Decision 623 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
535d slower than avg
Panel avg: 88d · This submission: 623d
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 24
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K921868.
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
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
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990