Cleared Traditional

K930047 - DSL IGFBP-3 RIA (DSL 6700)

K930047 is the FDA 510(k) clearance for DSL IGFBP-3 RIA (DSL 6700) by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 547-day FDA review.

K930047 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jul 1994
Decision
547d
Days
Class 1
Risk

K930047 is an FDA 510(k) clearance for the DSL IGFBP-3 RIA (DSL 6700). 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 6, 1994 after a review of 547 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K930047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date July 06, 1994
Days to Decision 547 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
459d slower than avg
Panel avg: 88d · This submission: 547d
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 K930047.
DSL ACTIVE IFGBP-3 ELISA
K951707 · Diagnostic Systems Laboratories, Inc. · May 1995
ACTIVE IGF-I ELISA
K951752 · Diagnostic Systems Laboratories, Inc. · May 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
K950228 · Diagnostic Systems Laboratories, Inc. · Feb 1995
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · Medix Biotech, Inc. · Mar 1992
AIA-PACK HGH
K905757 · Tosoh Medics, Inc. · Jan 1991
IGF-I BY EXTRACTION
K896808 · Nichols Institute Diagnostics · Jan 1990