QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

K112449 · Tianjin New Bay Bioresearch Co., Ltd. · LCX · Sep 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112449
• Device Name: QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
• Applicant: Tianjin New Bay Bioresearch Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Sep 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.

Device Story

Lateral flow immunochromatographic assay; detects human chorionic gonadotropin (hCG) in urine. Device consists of plastic housing containing test strip with colloidal gold conjugate (mouse monoclonal anti-beta hCG) and test line (mouse monoclonal anti-alpha hCG) and control line (goat anti-mouse polyclonal). User-operated (home use); urine applied to midstream test stick. Visual readout of test and control lines indicates presence of hCG. Assists in early pregnancy detection.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through comparison of intended use and physical properties.

Technological Characteristics

Lateral flow immunochromatographic assay; plastic housing; colloidal gold conjugate; mouse monoclonal antibodies (anti-beta hCG, anti-alpha hCG); goat anti-mouse polyclonal antibodies. Single-use, manual visual readout.

Indications for Use

Indicated for qualitative detection of hCG in urine for pregnancy testing in women. Suitable for over-the-counter 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

• Firstresponse Pregnancy Test (K030258)

Submission Summary (Full Text)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### 510(k) Number: k112449

Type of 510(k) Submission: Traditional

#### Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #1 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: [phone] Facsimile: 86-222-875-1516

#### Contact Person:

Hann Ping Wang Ph.D. Regulatory Consultant 5230 Via Primaria Yorba Linda, CA 92886

Land line: 714-693-0301 Cell: 714-686-2081 Email: [e-mail]

## Preparation Date:

January 11, 2011

#### Device Information:

Trade or Proprietary Name: QuikResponse™ One Step Midstream Early Pregnancy Test

Common/Usual Name:

Lateral flow immunochromatographic assay for detection of human chorionic gonadotropin in human urine

Device Classification Name: Immunoassay of human chorionic gonadotropin

Regulatory Name: Human chorionic gonadotropin (hCG) Test System

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# . Regulation Section: 21 CFR § 862. 1155

Regulatory Class: Class II

Product Code: LCX

Panel: Chemistry (75)

## Predicate Devices:

QuikResponse™ One Step Midstream Early Pregnancy Test device test is substantially equivalent to the Firstresponse Pregnancy Test cleared by FDA (K030258) for its stated intended use.

## Device Description:

The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.

### Intended Use:

QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.

### Comparison to Predicate Device(s):

Both devices (QuikResponse™ One Step Midstream Early Pregnancy Test device and Firstresponse Pregnancy Test) are for the qualitative determination of the human chorionic gonadotropin. Both test devices are single use devices.

#### Summary:

The information provided in this pre-market notification demonstrates that QuikResponse™ One Step Midstream Early Pregnancy Test device is substantially equivalent to Firstresponse Pregnancy Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supports substantial equivalence to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

10903 New Hampshire Avenue Silver Spring, MD 20993

Tianjin New Bay Bioresearch Co., Ltd. c/o Biosource Technology Hann-Ping Wang, Ph. D, Regulatory Consultant 5230 Via Primaria Yorba Linda, CA 92886

SEP
24 2012

Re: k112449

QuikResponse™M One Step Midstream Early Pregnancy Test Trade/Device Name: Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 7, 2012 Received: September 11, 2012

Dear Dr. Wang:

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).

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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Q. M. B. B.

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

Enclosure

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# INDICATIONS FOR USE

510(k) Number (k112449):

Device name: QuikResponse™ One Step Midstream Early Pregnancy Test.

Indications for Use:

QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.

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

Over-The-Counter Use (21 CFR 807 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)

R. Chula

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K112449 510(k)