Cleared Traditional

K800776 - TESTOK-125

K800776 is the FDA 510(k) clearance for TESTOK-125 by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800776 · Sorin Biomedica, Fiat, USA, Inc. · Chemistry device
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Apr 1980
Decision
14d
Days
Class 1
Risk

K800776 is an FDA 510(k) clearance for the TESTOK-125. 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 April 21, 1980 after a review of 14 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

Submission Details

510(k) Number K800776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 21, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 48
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K800776.
IMMOPHASE DTESTO RADIOIMMUNOASSAY-
K840187 · Corning Medical & Scientific · Mar 1984
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · Diagnostic Products Corp. · Jun 1983
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · Diagnostic Products Corp. · Dec 1981
TESTOSTERONE RIA KIT (125I)
K772191 · Diagnostic Products Corp. · Jan 1978