Cleared Traditional

K950510 - OCTEIA IGF-1 KIT

K950510 is the FDA 510(k) clearance for OCTEIA IGF-1 KIT by Immunodiagnostic Systems , Ltd.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K950510 · Immunodiagnostic Systems , Ltd. · Chemistry device
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Apr 1995
Decision
58d
Days
Class 1
Risk

K950510 is an FDA 510(k) clearance for the OCTEIA IGF-1 KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Tyne And Wear, GB). The FDA issued a Cleared decision on April 5, 1995 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunodiagnostic Systems , Ltd. devices

Submission Details

510(k) Number K950510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date April 05, 1995
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
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 22
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K950510.
IMMULITE HGH
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