Cleared Traditional

K961678 - HUMAN GROWTH HORMONE IMMUNOASSAY KIT

K961678 is the FDA 510(k) clearance for HUMAN GROWTH HORMONE IMMUNOASSAY KIT by Nichols Institute Diagnostics. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K961678 · Nichols Institute Diagnostics · Chemistry device
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Jul 1996
Decision
68d
Days
Class 1
Risk

K961678 is an FDA 510(k) clearance for the HUMAN GROWTH HORMONE IMMUNOASSAY KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on July 8, 1996 after a review of 68 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K961678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date July 08, 1996
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K961678.
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · Diagnostic Systems Laboratories, Inc. · May 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701 · Diagnostic Systems Laboratories, Inc. · Apr 1997
DSL 9100 IGF-II IRMA
K962758 · Diagnostic Systems Laboratories, Inc. · Aug 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
IMMULITE HGH
K955376 · Diagnostic Products Corp. · Feb 1996