Cleared Traditional

CIBA CORNING ACS ESTRADIOL IMMUNOASSAY (K932715) - FDA 510(k) Clearance

Class I Chemistry device.

K932715 · Ciba Corning Diagnostics Corp. · Chemistry device
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Dec 1993
Decision
182d
Days
Class 1
Risk

K932715 is an FDA 510(k) clearance for the CIBA CORNING ACS ESTRADIOL IMMUNOASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K932715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date December 03, 1993
Days to Decision 182 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
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 17
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K932715.
AURAFLEX(R) ESTRADIOL
K946199 · Organon Teknika Corp. · Apr 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · Diagnostic Products Corp. · Feb 1995
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991