LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD

K020968 · Pan Probe Biotech, Inc. · JHI · Jul 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020968
• Device Name: LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
• Applicant: Pan Probe Biotech, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jul 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Pan Probe Blotech (PPB), Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices are in vitro diagnostic (IVD) qualitative screening lateral flow chromatographic immunoassays that are designed for rapid detection of placental hCG related to pregnancy at an expected value cut-off level of 20 mlU of hCG/ml of human urine. These LiveSure™ IVD immunoassay devices for urinary hCG pregnancy screening are neer non to give visual, qualitative results and are intended for professional use only. The PPB LiveSure™ hCG Test Strip and Test Card Devices are not intended for quantitative results, nor over-the-counter sales, but provide only professional use preliminary screening data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result, and to rule c: I any non-pregnancy diseases that can also result in elevated hCG. Clinical considerations and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow chromatographic immunoassay for qualitative detection of hCG in human urine; cut-off 20 mIU/mL. Device components: sample reaction unit; colloidal gold conjugate pre-labeled with hCG-specific mouse-monoclonal antibody; chromatographic membrane pre-coated with mouse-anti-alpha-hCG capture antibodies (test band) and goat-antibody (control band). Operation: urine specimen reacts with gold conjugate; mixture migrates via capillary action; hCG-gold complex binds to capture antibodies at test region. Output: visual colored bands; two bands (control and test) indicate positive; one band (control) indicates negative. Used in clinical settings by professional staff; provides preliminary data to aid pregnancy diagnosis; requires clinical confirmation by medical professional.

Clinical Evidence

Clinical evaluation included 252 urine samples tested at an independent clinical lab and 136 samples tested in-house. Compared against clinical pregnancy diagnoses and predicate devices (ABI SureStep, Quidel QuickVue). Results showed 100% relative sensitivity, 100% relative specificity, and >99% overall accuracy. Comparison against quantitative Axsym EIA showed 100% sensitivity but 95% specificity, with discrepancies identified as false negatives in the EIA method.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: colloidal gold conjugate with mouse-monoclonal antibody; membrane with mouse-anti-alpha-hCG capture antibodies and goat-antibody control. Qualitative visual readout. Professional use only. No electronic components or software.

Indications for Use

Indicated for professional use as a qualitative screening tool for the detection of human chorionic gonadotropin (hCG) in human urine to aid in the diagnosis of pregnancy. Cut-off level is 20 mIU/mL. Not for quantitative use or over-the-counter sales.

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

• ABI's SureStep™ hCG Test
• Quidel's QuickVue™ hCG Assay

Reference Devices

• Abbott's Axsym™ hCG EIA assay

Submission Summary (Full Text)

{0}------------------------------------------------

## JUL 15 2002

# 510k Submission for the Pan Probe Biotech, Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG)

Rapid Urinary Pregnancy Test Immunoassay Devices

Pan Probe Biotech, Inc.

Revised July 11, 2002

### SUMMARY OF SAFETY AND EFFECTIVENESS

Pan Probe Bictech, Inc., has developed, manufactured, and tested, under Good Laboratory Practices guidelines, both Test Strip and Test Card in vitro diagnostic (IVD) devices for rapid qualitative testing of urine samples for the presence of human Chorionic Gonadotrpin (hCG) related to pregnancy at an Expected Value cut-off level of 20 mU of hCG/ml of urine. The IVD medical device trade names are the Pan Probe Biotech or PPB LiveSure™ hCG Screen Test Strip and Test Card Devices, having FDA assigned name: Human Chorionic Gonadotrpin (hCG) Test Systems, and classified as Class II device per 21 CFR 862.1155, with product code: DHA.

The PPB LiveSure™ hCG Screen (i.e., LiveSure™ hCG) Test Strip and Test Card Devices are rapid qualitative lateral flow chromatographic IVD immunoassays and are intended for professional IVD use only. The Pan Probe Biotech LiveSure™ hCG Test Strip & Test Card Devices provide only preliminary analytical data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result. Each test device consists of a sample reaction unit, a pink colored colloidal gold conjugate unit pre-labeled with hGC-spec fic mouse-monoclonal antibody, and a chromatographic membrane was precoated with mouse-antialpha-hCG capture antibodies at the test band region and goat-antibody at the process control band region. During the test, the human urine specimen is allowed to react with hCG-specific mouse-monocloral antibodycolloid gold conjugate, which has been predried on the test component of each device. The mixture then moves chromatographically upward on the capillary action. For a pregnancy-positive specimen, gold conjugate complex binds to hCG at a level of 20 mlU/ml or greater, forming an antibody-antigen complex. This complex binds to hCG antibody as captured regents on the Test Region and produces a colored band when hCG concentration is equal to or greater than 20 mlU/ml. Absence of this colored band in the Test Region suggests a negative result Summarizing, negative urine will produce only one pink colored band in the control region, while positive urine will produce two pink colored bands, in both the control and test regions.

In-house and external testing of LiveSure™ hCG Test Strip and Test Card Devices was done against currently marketed predicate hCG test devices, including: AB/s SureStep™ hCG Test and Quidel's QuickVue™ hCG Assay devices, as well as the quantitative Abbott's Axsym™ hCG ElA assay. Against clinical lab data on diagnoses of pregnancy, and against each other results, statistical agreement was obtained between LiveSure™ hCG IVD Test Strip and Test Card Devices versus the predicate ABI's SureStep™ and Quidel's QuickVue """ hCG Test IVD devices. In particular, complete agreement was obtained for 3 main statistical parameters: a) for relative sensilivity with positives pregnancy tests (100%), b) for relative specificity or agreement with negative pregnancy diagnoses (100%), and c) for over-all accuracy >99%, both at an independent clinical lab (testing 252 urine samples with clinically confirmed diagnoses and run by several licensed technologists), as well as by in-house testing of 136 urine samples (also with clinically confirmed diagnoses). Comparison of the same 252 urine assay results for both PPB LiveSure™ hCG Test Strip & Test Card Devices against quantitative hCG Axsym™ EJA Assay determinations at the external independent clinical lab resulted in: a) 100% percent agreement for relative sensitivity of positive ElA results, but relative specificity 153/161or 95.0% for ElA negatives, and an over-all statistical accuracy of 244/252 or 96.8%. The same statistice results were obtained for the AB/s SureStep™ and Quicel's QuickVue™ hCG Test devices, as well as versus the clinical lab diagnoses data of pregnancy. These results were thought to be due to 8 low ElA values out of 252 independent lab specimens and 5 low ElA negatives out of 136 in-house samples, all determined to be below 15 mlU/ml by the Axsym™ ElA method. These low Axsym™ ElA results were concluded to be False Negatives by ElA, since the same patients were independently confirmed to be clinically pregnant. Against this clinically pregnancy data, there was 100% positive agreement versus predicate ABI's SureStep™ and Quidel's QuickVue™ hGG Test devices results as well as for both PPB LiveSure™ hCG Test Strip and Test Card devices, both in-house and at the external independent clinical laboratory.

Thus, compared to independent clinically Positive diagnoses of pregnancy, these studies found that both PPB LiveSure™ hCG Test Strip and Test Card devices were substantially equivalent in performance to approved predicate ABI's SureStep™ and Quidel's QuickVue™ hCG test devices, as well as to the quantitative Axsym™ EIA assay results. Addit onally, compared to independent Negative diagnoses of pregnancy, these studies showed that both PPB LiveSure™ hCG Test Strip and Test Card devices were substantially equivalent in performance to approved predicate ABI's SureStep™ and QuickVue™ hCG test devices, and gave results that were 95% or better in equivalency to the quantitative Axsym™ EIA assay results. Substantial equivalency versus these two predicate IVD devices was thus confirmed for both PPB LiveSure™ hCG Test Strip and Test Card IVD devices.

Additional information on this submission may be obtained by contacting Alice Yu, Vice President, Pan Probe Biotech, Inc. at 1- 858-689-9936 or by fax at 1-858-689-6896.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

JUL 1 5 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Pan Probe Biotech, Inc. c/o Alfredo J. Quattrone, Ph.D., D.A.B.T. Medical Device Safety Section California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, CA 94234-7320

1-020968 Re:

> Trade/Device Name: LiveSure™ hCG Urinary Pregnancy Test Strip and Test Card Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: June 28, 2002 Received: July 1, 2002

Dear Dr. Quattrone:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

{3}------------------------------------------------

### 510k Submission for the Pan Probe Biotech, Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Immunoassay Devices

Pan Probe Biotech, Inc.

Proprietary Information

Revision D, July 11, 2002

## 510(k) Number (if known): 21 CFR 862.1155; Prod. Code: DHA

# DEVICE NAME: Pan Probe Biotech (PPB), Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices

## INDICATIONS FOR USE STATEMENT:

Pan Probe Blotech (PPB), Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices are in vitro diagnostic (IVD) qualitative screening lateral flow chromatographic immunoassays that are designed for rapid detection of placental hCG related to pregnancy at an expected value cut-off level of 20 mlU of hCG/ml of human urine. These LiveSure™ IVD immunoassay devices for urinary hCG pregnancy screening are neer non to give visual, qualitative results and are intended for professional use only. The PPB LiveSure™ hCG Test Strip and Test Card Devices are not intended for quantitative results, nor over-the-counter sales, but provide only professional use preliminary screening data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result, and to rule c: I any non-pregnancy diseases that can also result in elevated hCG. Clinical considerations and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Lian Cooper

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

Prescription Use: or (Per 21 CFF 801.109)

Over-the-Counter Use: (Optional Format 1-2-96)