POLY STAT HCG DIPSTICK TEST

K021386 · Alidex, Inc. · JHI · Aug 5, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021386
• Device Name: POLY STAT HCG DIPSTICK TEST
• Applicant: Alidex, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (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 Dipstick Test is an in vitro diagnostic device used for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use by healthcare professionals to aid in the early detection of pregnancy. The device utilizes a dipstick format; the user immerses the test strip into a urine sample. The presence of hCG is indicated by a visual color change on the test strip, which the clinician interprets to determine pregnancy status. This rapid diagnostic tool provides immediate results to assist in clinical decision-making regarding patient care and pregnancy management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Immunochromatographic dipstick test for hCG detection in urine. Visual interpretation of colorimetric results. Standalone diagnostic device.

Indications for Use

Indicated for the early detection of pregnancy by detecting human chorionic gonadotropin (hCG) in the urine of women suspected to be 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

## AUG 0 5 2002

Ms. Helen Landicho Director RA/QS Alidex, Inc. 12277 134th Ct. NE Suite 100 Redmond, WA 98052

:

Re: k021386

Trade/Device Name: The Poly stat hCG Dipstick Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: July 17, 2002 Received: July 19, 2002

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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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/cdrl/dsmaldsmamain.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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## SECTION 12.0 INDICATIONS FOR USE STATEMENT

510(k) Number: ___ K021386

Device Name: The Poly stat hCG Dipstick Test

Indications For Use:

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

(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

V Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

P. Bernhardt 129. Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices K CD 1386 510(k) Number _

Alidex, Inc.