POLY STAT HCG TEST

K012559 · Bion Diagnostic Sciences · JHI · Oct 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012559
• Device Name: POLY STAT HCG TEST
• Applicant: Bion Diagnostic Sciences
• Product Code: JHI · Clinical Chemistry
• Decision Date: Oct 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

Device Story

The Poly stat hCG Test is an in vitro diagnostic device designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples. It is intended for use by healthcare professionals to assist in the early detection of pregnancy. The device operates via immunochemical principles to identify the presence of the hCG hormone in a patient's urine specimen. Results are interpreted by the clinician to aid in clinical decision-making regarding pregnancy status. The device is intended for prescription use.

Indications for Use

Indicated for the detection of human chorionic gonadotropin (hCG) in the urine of women suspected of being pregnant for the purpose of early pregnancy detection.

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

OCT 1 6 2001

Ms. Helen Landicho, RAC Director Regulatory Affairs Bion Diagnostic Sciences, Inc. 12277 134th Ct., N.E. Redmond, WA 98052

> k012559 Trade/Device Name: The Poly stat hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: August 6, 2001 Received: August 8, 2001

Dear Ms. Kindell:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the 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 I ou may , and controls 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 If your device is exassinod (600 as controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r lease be deviloed that I Draination that your device complies with other requirements of the Act that I Drillas intatutes and regulations administered by other Federal agencies. You must or any I catales and registered and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quind) 05 control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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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oty stat hCG Test

## SECTION 12.0 INDICATIONS FOR USE STATEMENT

510(k) Number: K012559

Device Name: The Poly stat hCG Test

Indications For Use:

The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

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Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012559

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

lion Diagnostic Sciences, Inc.

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