IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

K050741 · Ind Diagnostic, Inc. · JHI · May 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050741
• Device Name: IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
• Applicant: Ind Diagnostic, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two site sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine. The IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two site sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.

Device Story

The IND One Step hCG Pregnancy Test is a lateral flow, qualitative, two-site sandwich immunoassay. It utilizes urine samples to detect the presence of human chorionic gonadotropin (hCG). The device is designed for professional use in clinical settings. The test provides a visual result, which the healthcare provider interprets to assist in the early detection of pregnancy.

Clinical Evidence

Method comparison study using 803 clinical urine samples against ICON hCG predicate. Results showed >99% positive agreement, 98% negative agreement, and 99% overall agreement. Discrepant samples were resolved using quantitative hCG methods. Analytical performance included precision testing (n=20 per concentration) and specificity testing against common endogenous/exogenous compounds.

Technological Characteristics

Qualitative lateral flow sandwich immunoassay. Components: strip with mouse anti-hCG test line antibody and goat anti-mouse control line antibody, enclosed in plastic cassette. Detection limit: 20 mIU/mL. Standardized to WHO 4th IRP (75/589). Visual endpoint (pink line). No electronic components or software.

Indications for Use

Indicated for professional use to qualitatively detect human chorionic gonadotropin (hCG) in urine as an aid in 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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 6 2005

Mr. Jason Peng Regulatory Affairs Manager IND Diagnostic Inc. 1629 Fosters Way Delta, B.C. V3M 6S7 Canada

Re: k050741

Trade/Device Name: IND One Step hCG Pregnancy Test- Cassette Format Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Peng:

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 (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

## Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to ough finding of substantial equivalence of your device to a legally promative notification - - e 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, rr you don't spections 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). You may obtain other general information on your responsibilities under the Act from the I va may other baller generers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

| 510(k) Number (if known): | K050741 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | IND One Step hCG Pregnancy Test - Cassette Format |
| Indications For Use: | IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto Sols

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

'Page 1 of 1__________________________________________________________________________________________________________________________________________________________________