MINISTRIP/ SERUM AND URINE COMBO HCG TEST

K974060 · International Newtech Development, Inc. · JHI · Apr 9, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974060
• Device Name: MINISTRIP/ SERUM AND URINE COMBO HCG TEST
• Applicant: International Newtech Development, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.

Device Story

The One-Step Ministrip/Serum and Urine Combo hCG is a qualitative, two-site sandwich immunoassay test kit. It is designed for the rapid determination of human chorionic gonadotropin (hCG) concentration in human serum and urine samples. The device is intended for use in clinical laboratory settings by trained personnel. The test provides a visual, qualitative result to aid in the early detection of pregnancy. The healthcare provider interprets the visual result to confirm pregnancy status, facilitating clinical decision-making regarding patient care.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic immunoassay.

Technological Characteristics

Two-site sandwich immunoassay; qualitative visual readout; lateral flow or strip-based format for serum and urine testing.

Indications for Use

Indicated for the qualitative detection of hCG in serum and urine for the early detection of pregnancy in a clinical laboratory setting.

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 - 9 1998

Dennis S.L. Hong, B.Sc.,B.M.L.Sc. Assistant Manager International Newtech Development Inc. 1629 Fosters Way Delta, B.C. Canada V3M ട്ടേ7

K974060 Re: One-Step Ministrip/Serum and Urine Combo hCG Requlatory Class: II Product Code: JHI March 19, 1998 Dated: Received: March 24, 1998

Dear Mr. Hong:

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 Requlations, Title 21, Parts 800 to 895. ಕ್ಷ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 requlation 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 regulations.

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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 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" (21 CFR 807.97). Other qeneral 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 Sitman

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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) Number (if known): `k974060`

Ice Name: `Ministrip / Serum and Urine Combo HCG Test`

cations For Use:

MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich
immunoassay test kit for rapid determination of hCG concentration in both serum
and urine for early detection of pregnancy. This test kit is used to obtain a visual
and qualitative result and is for clinical lab used only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. `k974060`

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)