Cleared Traditional

K954755 - COAT-A-COUNT DIRECT ANDROSTENEDIONE

K954755 is the FDA 510(k) clearance for COAT-A-COUNT DIRECT ANDROSTENEDIONE by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CIZ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K954755 · Diagnostic Products Corp. · Chemistry device
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Nov 1995
Decision
44d
Days
Class 1
Risk

K954755 is an FDA 510(k) clearance for the COAT-A-COUNT DIRECT ANDROSTENEDIONE. Classified as Radioimmunoassay, Androstenedione (product code CIZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 44 days - a notably fast clearance cycle.

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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K954755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date November 29, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
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 K954755.
ACTIVE ANDROSTENEDIONE EIA
K963002 · Diagnostic Systems Laboratories, Inc. · Aug 1996
ACTIVE ANDROSTANEDIOL GLUCURONIDE
K934751 · Diagnostic Systems Laboratories, Inc. · Jan 1994
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