Cleared Traditional

K841088 - SOMATOMEDIN-C RADIOIMMUNOASSAY KIT

K841088 is the FDA 510(k) clearance for SOMATOMEDIN-C RADIOIMMUNOASSAY KIT by Nichols Institute Diagnostics. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K841088 · Nichols Institute Diagnostics · Chemistry device
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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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - CFL Radioimmunoassay, Human Growth Hormone

All 21
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K841088.
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · Diagnostic Systems Laboratories, Inc. · Jul 1988
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · Nichols Institute Diagnostics · May 1985
HUMAN GROWTH HORMONE RIA KIT
K841094 · Diagnostic Products Corp. · May 1984
TANDEM - HGH KIT
K821366 · Hybritech, Inc. · Jun 1982
RIA SYS. FOR HUMAN GROWTH HORMONE
K780347 · Calbiochem-Behring Corp. · Apr 1978