POLY STAT SERUM/URINE HCG TEST

K030430 · Alidex, Inc. · JHI · Apr 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030430
• Device Name: POLY STAT SERUM/URINE HCG TEST
• Applicant: Alidex, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

Device Story

The Poly stat Serum/Urine hCG Test is an in vitro diagnostic device used for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine samples. It is intended for use by healthcare professionals to aid in the early detection of pregnancy. The device operates via an immunoassay principle to identify the presence of the hCG hormone. Results are interpreted by the clinician to assist in clinical decision-making regarding pregnancy status. The test is designed for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Qualitative immunoassay for hCG detection in serum or urine; professional use; in vitro diagnostic test system.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for early pregnancy detection in women suspected of being pregnant.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 8 2003

Ms. Helen Landicho, RAC Director Regulatory Affairs Alidex, Inc. 12277 134th CT., N.E., #100 Redmond, WA 98052

Re: k030430

> Trade/Device Name: The Poly stat Serum/Urine hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 5, 2003 Received: February 10, 2003

Dear Ms. Landicho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## SECTION 12,0 INDICATIONS FOR USE STATEMENT

510(k) Number: K030430

Device Name: The Poly stat Serum/Urine hCG Test

Indications For Use:

The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

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OR

R. Charles for Jean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 0304 36 7 510(k) Number _

V Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Alidex, Inc.