Cleared Traditional

SOMATOMEDIN-C RADIOIMMUNOASSAY KIT (K841088) - FDA 510(k) Clearance

Class I Chemistry device.

K841088 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
223d
Days
Class 1
Risk

K841088 is an FDA 510(k) clearance for the SOMATOMEDIN-C RADIOIMMUNOASSAY KIT. 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 October 22, 1984 after a review of 223 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 Diagnostics devices

Submission Details

510(k) Number K841088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date October 22, 1984
Days to Decision 223 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 88d · This submission: 223d
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.