ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST

K030533 · Cenogenics Corp. · LCX · Apr 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030533
• Device Name: ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
• Applicant: Cenogenics Corp.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

Device Story

Rapid lateral flow colloidal gold immunological test; detects human chorionic gonadotropin (hCG) in urine or serum. Device utilizes lateral flow technology to provide qualitative results; visual readout indicates presence of hCG. Used in clinical settings by professionals or at home by consumers. Provides rapid confirmation of pregnancy; assists in early clinical decision-making regarding prenatal care. Benefits patient through accessible, timely pregnancy status information.

Clinical Evidence

Clinical studies conducted at three sites. Comparison of ACCUNATE™-ONE STEP/CASSETTE vs. Abbott Test Pack Plus™ (n=131) showed 100% agreement. Comparison of ACCUNATE-CHOICE™ vs. Quidel Quick-Vue® (n=119) showed 100% agreement. Sensitivity testing (n=20 per concentration) confirmed 25 mIU/ml detection limit. Home-use study (n=107) comparing lay-user results to professional laboratory results showed 98% agreement.

Technological Characteristics

Lateral flow colloidal gold immunoassay. Qualitative detection of hCG. Sensitivity: 25 mIU/ml. Form factors include test strips and cassettes. No electronic components, software, or external energy sources required.

Indications for Use

Indicated for over-the-counter use by individuals for the qualitative detection of human chorionic gonadotropin (hCG) in urine to facilitate early pregnancy detection.

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

• Abbott Test Pack Plus™
• Quidel's Quick-Vue®

Submission Summary (Full Text)

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| Cenogenics Corporation | |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 100 Route 520 • Drawer 308<br>Morganville, New Jersey 07751 | Telephone [phone] • [phone]<br>Fax [phone] • e-mail: [e-mail] |

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Proprietary name: | ACCUNATE™-ONE STEP<br>ACCUNATE™ONE STEP CASSETTE<br>ACCUNATE-CHOICE™<br>ACCUNATE™ HOME PREGNANCY TEST |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Common name: | Pregnancy test for urine or serum |
| Classification: | 21CFR862.1155, Class II |
| Classification number: | 75DHA |
| Establishment: | Cenogenics Corporation<br>100 Route 520<br>Morganville, New Jersey 07751 |
| Contact: | Nitza Katz<br>Vice President |

K030533
APR 17 2003
ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.

Comparison studies were conducted at three clinic sites. Urine specimens from patients seeking confirmation of pregnancy were tested simultaneously with ACCUNATE™ONE-STEP and ACCUNATE™ONE-STEP CASSETTE and the Abbott Test Pack Plus™. The Test Pack Plus™ is a similar colloidal gold test for the qualitative determination of hCG in urine for the early detection of pregnancy. A total of 131 specimens were tested. Test results showed 100% agreement with the Abbott Test Pack Plus™. TABLE 1A demonstrates distribution of positive and negative specimens.

- Comparison of ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP 1A: TABLE CASSETTE with the Abbott Test Pack Plus™

| | ACCUNATE™-ONE STEP | ACCUNATE™-ONE STEP<br>CASSETTE | ABBOTT TEST PACK<br>PLUS™ |
|------------------|--------------------|--------------------------------|---------------------------|
| NO. OF POSITIVES | 63 | 63 | 63 |
| NO. OF NEGATIVES | 68 | 68 | 68 |

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Serum specimens from normal male and non pregnant females were tested simultaneously with ACCUNATE-CHOICE™ and Quidel's Quick-Vue®. The Quick-Vue is a similar device for the qualitative determination of hCG in urine or serum for the early detection of pregnancy. A total of 119 samples were tested. Test results showed 100% agreement with the Quick-Vue . Table 1B shows the distribution of positive and negative samples.

TABLE 1B: Comparison of ACCUNATE-CHOICE™ with QUICK-VUE®

| | ACCUNATE-CHOICE™ | QUICK-VUE® |
|------------------|------------------|------------|
| NO. OF POSITIVES | 59 | 59 |
| NO. OF NEGATIVES | 60 | 60 |

Twenty urine specimens and twenty serum specimens were spiked with hCG at concentrations of 5, 25, 50 and 100m IU/ml. Each urine specimen was tested at the hCG concentrations stated and at 0mlU/ml with ACCUNATE™ ONE-STEP, ACCUNATE™ ONE-STEP CASSETTES and ACCUNATE-CHOICE™. The serum specimens were tested with ACCUNATE-CHOICE™. Testing data demonstrates the sensitivity to be 25mlU/ml. Test results are shown in TABLE 2.

TABLE 2: Sensitivity Test Results

| | hCG CONCENTRATION | | | | |
|-----------------------|-------------------|---------|----------|----------|-----------|
| | 0IU/ml | 5mlU/ml | 25mlU/ml | 50mlU/ml | 100mlU/ml |
| NO. OF SAMPLES TESTED | 20 | 20 | 20 | 20 | 20 |
| POSITIVE RESULTS | 0 | 0 | 20 | 20 | 20 |
| NEGATIVE RESULTS | 20 | 20 | 0 | 0 | 0 |

A study comparing the test results obtained by the home user with the ACCUNATE™ HOME PREGNANCY TEST to the test results obtained by the professional user with the ACCUNATE™ ONE-STEP CASSETTE was performed at three clinic sites. A total of 107 participants were included in this study. The agreement between the home user and the laboratory professional test results was 98%. Table 3 shows the comparison test result data.

- TABLE 3: Comparison of the test results reported by the Home User with the test results reported by the laboratory.

| | Home User | Laboratory |
|---------------------|-----------|------------|
| Number of Positives | 47 | 46 |
| Number of Negatives | 59 | 61 |
| Number of Invalid | 1 | 0 |
| TOTAL | 107 | 107 |

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The above testing data demonstrates that ACCUNATE™-ONE STEP and the ACCUNATE™-ONE STEP CASSETTE are substantially equivalent to the Abbott Test Pack Plus™ and that the ACCUNATE-CHOICE™ is substantially equivalent to Quidel's Quick-Vue°. The test results obtained by the home user with the ACCUNATE™ HOME PREGNANCY TEST is substantially equivalent to the test results obtained by the laboratory professional with the ACCUNATE™ ONE-STEP CASSETTE. The devices are equivalent in test principle, sensitivity and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 7 2003

Ms. Nitza Katz Vice President Cenogenics. Corporation 100 Route 520 Morganville, NJ 07751

> k030533 Trade/Device Name: Accunate Home Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: February 10, 2003 Received: February 14, 2003

Dear Ms. Katz:

Re:

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. Iisting 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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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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030533

Device Name: ACCUNATE HOME PREGNANCY TEST

Indications For Use:

Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C Benson/P Jean Cooper

(Division Sign-Off) Division of Clinical Laborator 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter

(Optional Format 1-2-96)