CASSETTE/URINE HCG

K023638 · Ind Diagnostic, Inc. · LCX · Jan 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023638
• Device Name: CASSETTE/URINE HCG
• Applicant: Ind Diagnostic, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.

Device Story

The Urine HCG (Cassette Format) One Step Test Kit is a lateral flow immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is intended for over-the-counter (OTC) use by individuals for the early detection of pregnancy. The user applies a urine specimen to the test cassette; the presence of hCG is indicated by a visual color change on the test strip. The result is qualitative, providing a simple positive or negative readout. The device is a single-use diagnostic tool that aids in the early identification of pregnancy without requiring professional clinical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical of lateral flow hCG immunoassay test systems.

Technological Characteristics

Lateral flow immunoassay cassette; qualitative visual readout; single-use; in vitro diagnostic device.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in female urine specimens for the early detection of pregnancy. Intended for single-use, over-the-counter (OTC) diagnostic testing.

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 098 Gaither Road Rockville MD 20850

## JAN 0 3 2003

Dr. David Lee. MCIC, FCACB Director, Regulatory Affairs IND Diagnostic Inc. 1629 Fosters Way Delta. B.C. CANADA V3M 6S7

k023638 Re:

Trade/Device Name: Urine RCG (Cassette Format) One Step Test Kit Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 25, 2002 Received: December 10, 2002

Dear Dr. Lee:

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 (OS) 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). 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 Sutman

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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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K023638

Device Name: Urine HCG (Cassette format)
One Step Test Kit

## Indications For Use:

## One Step urine hCG (cassette format) Pregnancy Test

is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy.

This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.

Oilll

Dr. David Lee, MCIC, FCACB, Certified Clinical Biochemist.

October 31, 2002

Director,
Regulatory Affairs,
IND Diagnostic Inc.,
1629 Fosters Way, Delta, B. C.,
CANADA V3M 6S7
email [e-mail]

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)