Cleared Traditional

K955376 - IMMULITE HGH

K955376 is the FDA 510(k) clearance for IMMULITE HGH by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K955376 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
84d
Days
Class 1
Risk

K955376 is an FDA 510(k) clearance for the IMMULITE HGH. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 84 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 Products Corp. devices

Submission Details

510(k) Number K955376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date February 16, 1996
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
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 17
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K955376.
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
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