Cleared Traditional

K875229 - DSL SOMATOMEDIN-C (DSL #5600)

K875229 is the FDA 510(k) clearance for DSL SOMATOMEDIN-C (DSL #5600) by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K875229 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jul 1988
Decision
192d
Days
Class 1
Risk

K875229 is an FDA 510(k) clearance for the DSL SOMATOMEDIN-C (DSL #5600). Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 192 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K875229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date July 01, 1988
Days to Decision 192 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
104d slower than avg
Panel avg: 88d · This submission: 192d
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 K875229.
AIA-PACK HGH
K905757 · Tosoh Medics, Inc. · Jan 1991
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · Medix Biotech, Inc. · Dec 1989
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · Nichols Institute Diagnostics · May 1985
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · Nichols Institute Diagnostics · Oct 1984