ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)

K060019 · Artron Laboratories, Inc. · LCX · Feb 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060019
• Device Name: ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
• Applicant: Artron Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Device Story

Solid-phase, immunochromatographic assay; detects hCG in urine. User applies urine to absorbent pad; sample migrates via capillary action. Test utilizes mouse monoclonal anti-alpha-hCG antibodies on membrane and mouse monoclonal anti-beta-hCG antibody-colloidal gold conjugate. Presence of hCG results in colored line in test region; control line indicates valid test. Used in home or clinical settings; interpreted visually by patient or healthcare professional within 5-10 minutes. Provides qualitative result to assist in pregnancy determination; requires follow-up with specific clinical methods for final diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Solid-phase immunochromatographic assay. Materials: mouse monoclonal anti-alpha-hCG antibody coated membrane, mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate, goat anti-mouse IgG control. Formats: strip, cassette, midstream. Qualitative colorimetric output. Traceable to WHO 3rd International Standard. No instrumentation required.

Indications for Use

Indicated for the qualitative detection of hCG in urine to aid in early pregnancy determination. Intended for both over-the-counter (lay user) and professional clinical use.

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.

Predicate Devices

• Victorch hCG Strip (k013702)
• Wondfo One Step hCG Urine Pregnancy Test (k043443)

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 features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 7 2006

Mr. Jerry Zheng Vice President Artron Laboratories Inc. 3938 North Fraser Way Burnaby, BC V5J 5H6 Canada

k060019 Re:

K000017
Trade/Device Name: Artron One-Step human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device (Artron One-Step hCG strip/cassette/midtream) Regulation Number: 21 CFR §862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: December 20, 2005 Received: January 4, 2006

Dear Mr. Zheng:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard) to regard to the Medical Device Amendments, or to conninered pror to this 2011/17/20, in accordance with the provisions of the Federal Food, Drug, devices that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererore, manov as 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 n may be subject to Bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA oun or loand in There announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase or acrisou and i termination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I 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 ills letter will anow you to begin mancellig of substantial equivalence of your device to a legally premarks notification: "The I DTP interlig to 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, If you desire specific mostion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v Itro Diagnoution 2010 anding by reference to premarket notification" (21CFR Part 807.97). regulation entitiou, "Misoranians of your responsibilities under the Act from the I ou inay of amall Manufacturers, 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,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Artron One-Step Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device

## Indications for Use 510(k) Number:

Device Name:

uman Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device

(Artron One-Step hCG strip/cassette/midstream)

## Indications for Use:

Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative Arton One beep 100 borionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.

For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Image /page/2/Picture/8 description: The image shows the words "Prescription Use" followed by a blank line with an "X" on it. Below that, the text "(Part 21 CFR 801 Subpart D)" is visible. The text is in bold font.

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 Device Evaluation (ODE)

Ann Chappie

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060019