Cleared Traditional

K955440 - IMMULITE SHBG (MODIFICATION)

K955440 is the FDA 510(k) clearance for IMMULITE SHBG (MODIFICATION) by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K955440 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
59d
Days
Class 1
Risk

K955440 is an FDA 510(k) clearance for the IMMULITE SHBG (MODIFICATION). Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 21, 1995 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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 K955440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date December 21, 1995
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 52
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K955440.
ELECSYS TESTOSTERONE ASSAY
K964889 · Boehringer Mannheim Corp. · Mar 1997
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K963080 · Bayer Corp. · Sep 1996
IMMULITE TOTAL TESTOSTERONE
K955870 · Diagnostic Products Corp. · Feb 1996
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685 · Organon Teknika Corp. · Nov 1995
ACTIVE FREE TESTOSTERONE RIA
K952281 · Diagnostic Systems Laboratories, Inc. · Jul 1995
IMMULITE SHBG
K941797 · Diagnostic Products Corp. · Oct 1994