Cleared Traditional

K841948 - TESTOSTERONE DIRECT RADIOIMMUNOASSAY

K841948 is an FDA 510(k) clearance for TESTOSTERONE DIRECT RADIOIMMUNOASSAY, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K841948 · Sorin Biomedica, Fiat, USA, Inc. · Chemistry device
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Jun 1984
Decision
42d
Days
Class 1
Risk

K841948 is an FDA 510(k) clearance for the TESTOSTERONE DIRECT RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 42 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 Sorin Biomedica, Fiat, USA, Inc. devices

FDA 510(k) Submission Details - K841948

510(k) Number K841948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 25, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 65
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K841948.
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671 · Diagnostic Systems Laboratories, Inc. · Dec 1985
DSL ANDROSTENDIONE RIA (DSL #4200)
K854674 · Diagnostic Systems Laboratories, Inc. · Dec 1985
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423 · Diagnostic Products Corp. · Feb 1985
IMMOPHASE DTESTO RADIOIMMUNOASSAY-
K840187 · Corning Medical & Scientific · Mar 1984
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · Diagnostic Products Corp. · Jun 1983
LEECO TESTOSTERONE DIAGNOSTIC KIT
K830512 · Leeco Diagnostics, Inc. · Apr 1983