Cleared Traditional

K934751 - ACTIVE ANDROSTANEDIOL GLUCURONIDE

K934751 is the FDA 510(k) clearance for ACTIVE ANDROSTANEDIOL GLUCURONIDE by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (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

Submission Details

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.

Device Classification

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
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