PREGNANCY ONE STEP RAPID TEST

K103574 · Lehnus & Associates Consulting · LCX · Jul 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103574
• Device Name: PREGNANCY ONE STEP RAPID TEST
• Applicant: Lehnus & Associates Consulting
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only. The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only. The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.

Device Story

Rapid sandwich immunoassay for qualitative hCG detection in human urine; utilizes membrane pre-coated with monoclonal anti-hCG antibodies (test line) and anti-mouse antibodies (control line). Urine sample reacts with mouse anti-hCG antibody-colloidal gold conjugate; mixture migrates via capillary action. Positive result indicated by red test band; control band confirms proper flow/volume. Available in strip, cassette, and midstream formats. Strip/cassette used by healthcare professionals in clinical settings; midstream format used by lay users for OTC self-testing. Results interpreted visually by user/clinician to aid pregnancy diagnosis. Benefits include rapid, early detection of pregnancy.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing of analytical performance.

Technological Characteristics

Qualitative sandwich immunochromatographic assay. Membrane pre-coated with monoclonal anti-hCG antibodies and anti-mouse antibodies. Dye conjugate: mouse anti-hCG antibody-colloidal gold. Formats: strip, cassette, midstream. Storage: 2-30°C. Traceable to WHO 4th International Standard for hCG. No electronic components or software.

Indications for Use

Indicated for women of childbearing age, including those peri-menopausal or suspected of pregnancy, for the qualitative detection of hCG in urine to aid in early pregnancy detection. Midstream format for OTC self-testing; strip and cassette formats for professional 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Zhejiang Orient Gene Biotech Co., Ltd. c/o Gary Lehnus 150 Cherry Lane Rd. East Stroudsburg, PA 18301

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 2 8 2011

Re: k103574

Trade/Device Name: Pregnancy One Step Rapid Test (Strip), (Cassette), (Midstream) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (I-ICG) Test System Regulatory Class: Class II Product Code: LCX Dated: 21 July 2011 Received: 26 July 2011

Dear Mr. Lehnus:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-fre ne [phone] or [phone] or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

C.C.

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

ﺗﺮﮐﺰ ﭘﺎ

Enclosure

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## Indications for Use

510(k) Number (if known):

Pregnancy One Step Rapid Test (Strip) Device Name:

Indications For Use:

The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Rute Charles

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103574

Page 1 of 3

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## Indications for Use

510(k) Number (if known):

Device Name: ___ Pregnancy One Step Rapid Test (Cassette)

Indications For Use:

The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.

Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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 (OIVD)

Rute Club

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 103574

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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.

AND/OR Over-The-Counter Use X Prescription Use (Part 21 CFR 801 Subpart D) (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 (OIVD)

Rute Choster

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k103574