Cleared Traditional

ACS ESTADIOL-6 II (K970386) - FDA 510(k) Clearance

Class I Chemistry device.

K970386 · Chiron Diagnostics Corp. · Chemistry device
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Jun 1997
Decision
121d
Days
Class 1
Risk

K970386 is an FDA 510(k) clearance for the ACS ESTADIOL-6 II. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 121 days - within the typical 510(k) review window.

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 Chiron Diagnostics Corp. devices

Submission Details

510(k) Number K970386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date June 04, 1997
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
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 49
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K970386.
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc. · Oct 1997
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
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