BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST

K973350 · Bio-Rad · JLX · Feb 9, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973350
• Device Name: BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
• Applicant: Bio-Rad
• Product Code: JLX · Clinical Chemistry
• Decision Date: Feb 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1395
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE (17-OHP) TEST IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF 17-HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE AS AN AID IN SCREENING NEWBORNS FOR CONGENITAL ADRENAL HYPERPLASIA.

Device Story

The Bio-Rad Microplate 17-Hydroxyprogesterone (17-OHP) test is an in vitro diagnostic assay used to measure 17-OHP levels in dried blood spot samples. It is designed for use in clinical laboratory settings to assist in screening newborns for congenital adrenal hyperplasia. The device provides quantitative results that healthcare providers use to identify infants requiring further diagnostic evaluation for adrenal conditions. The test is intended for professional use.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic microplate assay for quantitative measurement of 17-hydroxyprogesterone in dried blood spots. Class I device, product code JLX.

Indications for Use

Indicated for the quantitative measurement of 17-hydroxyprogesterone in dried blood spots as an aid in screening newborns for congenital adrenal hyperplasia.

Regulatory Classification

Identification

A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

John W. Nelson Manager, Regulatory Affairs Bio-Rad Laboratories 4000 Alfred Nobel Drive Hercules, California 94547-1803

FEB - 9 1998

Re : K973350 Microplate 17-Hydroxyprogesterone Test Requlatory Class: I Product Code: JLX Dated: December 17, 1997 December 19, 1997 Received:

Dear Mr. Nelson:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 requlation (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 Butman

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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510(k) Number (If Known)
Device Name: 17- HYDROXYPROGESTERONE TEST.
Indications for Use:
THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE
(17-OHP) TEST IS DESIGNED FOR THE
QUANTITATIVE MEASUREMENT OF ιτα
HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS
IT IS INTENDED FOR IN VITRO DIAGNOSTIC
USE AS AN ALD IN SCREENING NEWBORNS

HYPERPLASIA.
FOR CONGENITAL, ADRENAL P. Berliat (ford. Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Doμία

Clinical Laboratory Device

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR