ACS ESTADIOL-6 II

K970386 · Chiron Diagnostics Corp. · CHP · Jun 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970386
• Device Name: ACS ESTADIOL-6 II
• Applicant: Chiron Diagnostics Corp.
• Product Code: CHP · Clinical Chemistry
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1260
• Device Class: Class 1

Intended Use

The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradiol in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.

Device Story

The ACS:180 Estradiol-6 II Assay is an in vitro diagnostic reagent kit used on the Chiron Diagnostics ACS:180 automated chemiluminescence system. It measures estradiol levels in serum samples. The system utilizes chemiluminescent immunoassay technology to quantify the hormone. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides quantitative estradiol concentrations, which healthcare providers use to assess ovarian function and monitor follicular development during fertility treatments or diagnostic workups. This information assists clinicians in making informed decisions regarding patient reproductive care and treatment adjustments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated chemiluminescence immunoassay system. Reagent-based quantitative analysis. Designed for use with the ACS:180 automated platform. Class I device.

Indications for Use

Indicated for quantitative determination of estradiol in serum to aid in assessing ovarian function and monitoring follicular development in patients requiring clinical evaluation of reproductive health.

Regulatory Classification

Identification

An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUN - 4 1997

Thomas F. Flynn
Manager, Regulatory Affairs & Compliance
Chiron Diagnostics Corporation
63 North Street
Medfield, Massachusetts 02052-1688

Re: K970386
ACS Estradiol-6 II Immunoassay
Regulatory Class: I
Product Code: CHP
Dated: January 31, 1997
Received: February 3, 1997

Dear Mr. Flynn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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02/97 15:25 508 359 3885 CHIRON LEGAL 002/003

# Company Confidential

Page ___ of ___

510(k) Number (if known): K970386

Device Name: **Chiron Diagnostics ACS:180 Estradiol-6 II Assay**

## Indications for Use:

The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradiol in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.


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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)

ACS:180 Estradiol-6 II 510(k)
June 2, 1997