Cleared Traditional

K932951 - DELFIA TESTTOSTERONE KIT

K932951 is an FDA 510(k) clearance for DELFIA TESTTOSTERONE 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 47-day FDA review.

K932951 · Wallac OY · Chemistry device
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Aug 1993
Decision
47d
Days
Class 1
Risk

K932951 is an FDA 510(k) clearance for the DELFIA TESTTOSTERONE 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 August 3, 1993 after a review of 47 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 Wallac OY devices

FDA 510(k) Submission Details - K932951

510(k) Number K932951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1993
Decision Date August 03, 1993
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
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 K932951.
IMMULITE SHBG
K941797 · Diagnostic Products Corp. · Oct 1994
DELFIA SHBG KIT
K940449 · Wallac OY · Sep 1994
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · Ciba Corning Diagnostics Corp. · Dec 1993
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
K924257 · Serono-Baker Diagnostics, Inc. · Nov 1992
DSL ACTIVE SHBG (DSL 7400)
K915823 · Diagnostic Systems Laboratories, Inc. · Mar 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
K915164 · Serono-Baker Diagnostics, Inc. · Mar 1992