Cleared Traditional

K940449 - DELFIA SHBG KIT

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

K940449 · Wallac OY · Chemistry device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 88d · This submission: 217d
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 54
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
DSL ACTIVE SHBG (DSL 7400)
K915823 · Diagnostic Systems Laboratories, Inc. · Mar 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570 · Incstar Corp. · Jan 1992