QUICKSTICK ONE STEP HCG PREGNANCY TEST

K972682 · Phamatech · LCX · Aug 1, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972682
• Device Name: QUICKSTICK ONE STEP HCG PREGNANCY TEST
• Applicant: Phamatech
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The QuickstickTM One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

Device Story

Quickstick One Step HCG Pregnancy Test is a qualitative immunoassay for hCG detection in urine. Device utilizes visual color sandwich immunoassay technology; specific antibody-hCG-antibody complexes form to indicate presence of analyte. Intended for use by individuals suspecting pregnancy; provides alternative to initial clinical office visit for early confirmation. Results allow for rapid initiation of prenatal care. Device is a point-of-care/home-use test; results interpreted visually by user.

Clinical Evidence

Clinical evidence includes a clinical sample correlation study and a blind labeled spiked HCG study. Correlation studies against Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test showed >99% correlation. Blind labeled spiked consumer study (n=246) demonstrated 122/123 sensitivity, 122/123 specificity, and 244/246 accuracy in lay user hands.

Technological Characteristics

Visual color sandwich immunoassay; immunochemical sandwich assay principle using specific antibody/HCG/antibody complexes. Qualitative detection method.

Indications for Use

Indicated for individuals who suspect they may be pregnant to detect hCG in urine for early pregnancy confirmation.

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

• Unipath Clearview HCG
• Abbott Laboratories' Fact Plus
• Syntron Bioresearch Be Sure Pregnancy Test

Reference Devices

• Quidel Rapidvue

Submission Summary (Full Text)

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K972682

AUG - 1 - 1997

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

QuickstickTM One Step HCG Pregnancy Test (9010J) Identification:

Immunoassay for the Qualitative Detection of Human Chorionic Description: Gonadotropin (hCG) in Urine for the Early Pregnancy

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 San Diego, California 92126, USA

The QuickstickTM One Step HCG Pregnancy Test is intended to Intended Use: detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

The QuickstickTM One Step HCG Pregnancy Test, like many Technology: commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Unipath Clearview HCG (Mountainview, CA 94043), Abbott Laboratories' Fact Plus (Abbott Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / HCG / antibody / complexes.

Performance: The product performance characteristics of the QuickstickTM One Step HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech Quickstick™ One Step HCG Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations studies using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). A blind labeled spiked consumer study was performed, the Phamatech QuickstickTM exhibited excellent sensitivity (122/123), specificity (122/123), and accuracy (244/246) in the hands of lay users.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickstickTM One Step HCG Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.

【出】【要】【

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized profiles forming the body of the eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUD - 1 1997

Tuan H. Pham President Phamatech 9265 Activity Road, #112 San Diego, California 92126

Re : K972682 Quickstick™ One Step HCG Pregnancy Test Regulatory Class: II Product Code: LCX Dated: July 17, 1997 Received: July 17, 1997

Dear Mr. Pham:

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 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 The general controls provisions of the Act 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 requirement, 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.

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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/dsmamain.html".

Sincerely yours,
Steven Litman

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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## INDICATIONS FOR USE

Applicant: Phamatech

510(k) Number (if known):

Device Name: Quickstick IN One Step Pregnancy Test

Indications for Use:

Over-the-Counter HCG (pregnancy) tests are for the greating individuals who, for any reason, believe they may be pregnant. This test detects HCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since HCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation tests by trained clinical technicians.

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Concurrence of CDRH Office of Device Evaluation (ODE)

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| Division of Clinical Laboratory Devices | |
| 510(k) Number | k972682 |

Division Sign-Off
Division of Clinical Laboratory Devices

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| Prescription Use: Per 21 CFR 801.109 | ✓ |
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OR Over the Counter _______