Cleared Traditional

K970386 - ACS ESTADIOL-6 II

K970386 is an FDA 510(k) clearance for ACS ESTADIOL-6 II, manufactured by Chiron Diagnostics Corp.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

FDA 510(k) Submission Details - K970386

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

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 39
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
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
K970643 · Johnson & Johnson Clinical Diagnostics, Inc. · Mar 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · Bio-Rad Laboratories, Inc. · Feb 1997
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
VIDAS ESTRADIOL II (E2II) ASSAY
K955647 · Biomerieux Vitek, Inc. · Feb 1996
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · Ciba Corning Diagnostics Corp. · Dec 1995