MODIFICATION OF: DAVIDSTRIP HCG

K991067 · Simex Medical, Inc. · JHI · Apr 27, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991067
• Device Name: MODIFICATION OF: DAVIDSTRIP HCG
• Applicant: Simex Medical, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.

Device Story

DavidStrip hCG is a lateral flow, two-site sandwich immunoassay test kit. It utilizes urine samples to detect human chorionic gonadotropin (hCG). The device operates via immunochromatographic principles where hCG in the sample binds to labeled antibodies, migrating along a membrane to produce a visual color change indicating the presence of the hormone. It is intended for professional use in clinical settings. The healthcare provider interprets the visual result directly from the test strip to confirm pregnancy status, facilitating clinical decision-making regarding patient care.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay; two-site sandwich immunoassay format; visual qualitative readout; urine specimen matrix.

Indications for Use

Indicated for professional use for the qualitative detection of hCG in urine to aid in the early detection of pregnancy.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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APR 2 7 1999

Ms. Michelle J. Hall Vice President Simex Medical Inc. 560 Industry Drive Tukwila, Washington 98188

Re: K991067

> Trade Name: DavidStrip hCG Regulatory Class: II Product Code: JHI Dated: June 1, 1998 Received: March 30, 1999

Dear Ms. Hall:

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 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). 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 (Premarket Approval), 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 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 general 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Page__________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K991067 |
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| Device Name: | David Strip hCG |

Indications For Use:

DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991067

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

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OR

Over-The-Counter Use_

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(Optional Format 1-2-96)