Cleared Traditional

ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT (K921868) - FDA 510(k) Clearance

Class I Chemistry device.

K921868 · Endocrine Sciences Products · Chemistry device
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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.

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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.