Cleared Traditional

K915164 - SRI TESTOSTERONE ENZYME IMMUNOASSAY

K915164 is an FDA 510(k) clearance for SRI TESTOSTERONE ENZYME IMMUNOASSAY, manufactured by Serono-Baker Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K915164 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Mar 1992
Decision
109d
Days
Class 1
Risk

K915164 is an FDA 510(k) clearance for the SRI TESTOSTERONE ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 109 days - within the typical 510(k) review window.

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 Serono-Baker Diagnostics, Inc. devices

FDA 510(k) Submission Details - K915164

510(k) Number K915164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1991
Decision Date March 02, 1992
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
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 69
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K915164.
DELFIA TESTTOSTERONE KIT
K932951 · Wallac OY · Aug 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
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570 · Incstar Corp. · Jan 1992
SHBG IRMA KIT
K905247 · Ventrex Laboratories, Inc. · Jan 1991
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100 · Diagnostic Systems Laboratories, Inc. · Oct 1990