QUICKSTICK PRO HCG TEST

K974615 · Phamatech · JHI · Jan 26, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974615
• Device Name: QUICKSTICK PRO HCG TEST
• Applicant: Phamatech
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The QuickStick ProTM HCG Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine. 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. This device is intended for clinical laboratories and physician's office labs as an IVD test for the qualitative measurement of hCG in urine.

Device Story

QuickStick Pro HCG 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 professional use in clinical laboratories and physician office labs. Healthcare providers interpret visual color results to confirm pregnancy. Device provides rapid qualitative assessment, aiding clinical decision-making regarding pregnancy status.

Clinical Evidence

Clinical sample correlation study and blind labeled spiked HCG study performed. Compared against Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test. Results showed >99% correlation. Clinical laboratory study demonstrated >99% sensitivity, >99% specificity, and >99% accuracy in professional use settings.

Technological Characteristics

Visual color sandwich immunoassay. Qualitative detection of hCG. Manual test format. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of hCG in urine to confirm pregnancy. Intended for use in clinical laboratories, hospitals, reference labs, and physician's office labs (POLs).

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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K974615

JAN 26 1998

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

QuickStick ProTM HCG Test (9009) ldentification:

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

Intended Use: The QuickStick ProTM HCG Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine. 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. This device is intended for clinical laboratories and physician's office labs as an IVD test for the qualitative measurement of hCG in urine.

The QuickStick ProTM HCG Test, like many commercially available Technology: 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 QuickStick ProTM 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 Pro™ HCG 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 clinical laboratory study was performed, the Phamatech QuickStick ProTM exhibited excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 26 1998

Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112-113 San Dieqo, California 92126

Re : K974615 QuickStick Pro™ HCG Test Regulatory Class: II Product Code: JHI Dated: December 10, 1997 Received: December 11, 1997

Dear Mr. Mongiovi:

regulations.

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlatory In addition, FDA may publish further announcements action. 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

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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 Bitman

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 Pro IM Pregnancy Test

Indications for Use:

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. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine. Clinical labs can include hosptials and reference labs. POLs can include mini-clinics.

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH Office of Device Evaluation (ODE)

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

Prescription Use:
Per 21 CFR 801.109

OR Over the Counter -

Kmoore for Montgomery
(Division Sign-Off)

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Division of Clinical Laboratory Devices
510(k) Number 974615