Cleared Traditional

K934751 - ACTIVE ANDROSTANEDIOL GLUCURONIDE

K934751 is an FDA 510(k) clearance for ACTIVE ANDROSTANEDIOL GLUCURONIDE, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CIZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K934751 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jan 1994
Decision
98d
Days
Class 1
Risk

K934751 is an FDA 510(k) clearance for the ACTIVE ANDROSTANEDIOL GLUCURONIDE. Classified as Radioimmunoassay, Androstenedione (product code CIZ), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on January 10, 1994 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1075 - 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 Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K934751

510(k) Number K934751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date January 10, 1994
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

CIZ Device Classification - Class 1, General Controls

Product Code CIZ Radioimmunoassay, Androstenedione
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1075
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 - CIZ Radioimmunoassay, Androstenedione

Devices cleared under the same product code (CIZ) and FDA review panel - the closest regulatory comparables to K934751.
ACTIVE ANDROSTENEDIONE EIA
K963002 · Diagnostic Systems Laboratories, Inc. · Aug 1996
COAT-A-COUNT DIRECT ANDROSTENEDIONE
K954755 · Diagnostic Products Corp. · Nov 1995
ANDROSTENEDIONE 125I KIT BY RIA
K860559 · Immuchem Corp. · Mar 1986
DSL ANDROSTENEDIONE RIA (DSL # 4200)
K854673 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
K854650 · Diagnostic Systems Laboratories, Inc. · Dec 1985
COAT-A-COUNT ANDROSTENEDIONE RIA KIT
K844398 · Diagnostic Products Corp. · Dec 1984