Cleared Traditional

K875229 - DSL SOMATOMEDIN-C (DSL #5600)

K875229 is an FDA 510(k) clearance for DSL SOMATOMEDIN-C (DSL #5600), manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K875229

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.

CFL Device Classification - Class 1, General Controls

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 29
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K875229.
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · Medix Biotech, Inc. · Dec 1989
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · Cyberfluor, Inc. · Aug 1988
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
K860228 · Boots-Celltech Diagnostics, Inc. · Feb 1986
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892 · Immuno Nuclear Corp. · Jun 1985