Cleared Traditional

K940449 - DELFIA SHBG KIT

K940449 is an FDA 510(k) clearance for DELFIA SHBG KIT, manufactured by Wallac OY. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K940449 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
217d
Days
Class 1
Risk

K940449 is an FDA 510(k) clearance for the DELFIA SHBG KIT. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on September 6, 1994 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallac OY devices

FDA 510(k) Submission Details - K940449

510(k) Number K940449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1994
Decision Date September 06, 1994
Days to Decision 217 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
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

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 68
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K940449.
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
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · Ciba Corning Diagnostics Corp. · Dec 1993
DELFIA TESTTOSTERONE KIT
K932951 · Wallac OY · Aug 1993
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
K924257 · Serono-Baker Diagnostics, Inc. · Nov 1992