Cleared Traditional

K970701 - DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)

K970701 is an FDA 510(k) clearance for DSL 1900 ACTIVE HUMAN GROWTH HORMONE IR..., 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 35-day FDA review.

K970701 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
35d
Days
Class 1
Risk

K970701 is an FDA 510(k) clearance for the DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900). 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 April 2, 1997 after a review of 35 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 Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K970701

510(k) Number K970701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1997
Decision Date April 02, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K970701.
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
K972761 · Sealite Sciences, Inc. · Sep 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · Diagnostic Systems Laboratories, Inc. · May 1997
DSL 9100 IGF-II IRMA
K962758 · Diagnostic Systems Laboratories, Inc. · Aug 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
K961678 · Nichols Institute Diagnostics · Jul 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
K960551 · Diagnostic Systems Laboratories, Inc. · Mar 1996