BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG

K070921 · Applied Dna Technologies, Inc. · JHI · Jun 29, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070921
• Device Name: BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
• Applicant: Applied Dna Technologies, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Device Story

Rapid chromatographic immunoassay for qualitative hCG detection in urine; utilizes test reagent strip with mouse monoclonal anti-alpha-hCG antibody-coated membrane and dried chemical pad containing mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate; control antibodies consist of goat anti-mouse IgG. Device formats include cassette and dipstick. Operated by healthcare professionals in clinical settings or physician office labs (POLs). Visual interpretation of test lines provides qualitative result; aids in early pregnancy determination. Requires confirmatory testing for final diagnosis.

Clinical Evidence

Method comparison study conducted at two physician office laboratories (POLs) using 95 clinical urine samples. Subject device compared to predicate (ACON One Step hCG). Results showed 100% agreement (48/48 positive, 47/47 negative). Analytical performance included precision testing across multiple lots and concentrations (0-100 mIU/mL), specificity testing against interfering substances (LH, FSH, TSH, and common OTC/prescription drugs), and hook effect testing up to 2,000,000 mIU/mL. No clinical sensitivity/specificity studies were required as the device is a qualitative screening assay.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: mouse monoclonal anti-alpha-hCG antibody-coated membrane, mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate, goat anti-mouse IgG control. Sensitivity: 20 mIU/mL. Standardized to WHO Fourth International Standard 75/589. Formats: Cassette and Dipstick.

Indications for Use

Indicated for the qualitative detection of hCG in urine to aid in early pregnancy determination in clinical and physician office laboratory settings. Prescription use only.

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

• Acon One Step Pregnancy Urine Test (k993203)

Submission Summary (Full Text)

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

## The Assigned 510(k) number is k070921

Date of Summary: June 26, 2007

JUN 2 9 2007

## Common Name: hCG (Human Chorionic Gonadotropin) Pregnancy Test

## Regulatory Information:

- 1. Regulation section: 21 CFR part 862.1155, Human Chorionic Gonadotropin test system
- 2. Classification: Class II
- 3. Product Code: JHI, radioimmunoassay, human chorionic gonadotropin
- 4. Panel: Clinical Chemistry 75

## Name of Submitter:

Applied DNA Technologies Inc. 6310 Nancy Ridge Dr. Suite 106 San Diego, CA 92121, USA

## Contact Person:

Feng-Yu Lee

## Identification / Product Name:

Bionexia™ hCG Pregnancy Cassette and Dipstick Tests

## Description:

The Bionexia™ hCG Pregnancy Test will be distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

#### Intended Use:

The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy.

The test kits are for health care professionals use including professionals at physician's office labs (POLs).

For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

## Predicate Kit:

ACON One Step Pregnancy Urine Test is used as predicate device for ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests to compare their performance of required studies.

510(k) numbers for predicate devices is: ACON One Step Pregnancy Urine Test

K 993203

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## Performance:

The product performance characteristics of ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests were evaluated in the blind-labeled spiked control studies and blind-labeled clinical specimen correlation study including POLs site study. The results of these studies demonstrate ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine Test.

(1) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical urine specimens evaluated, the study was conducted at two POL sites. (Additionally, 20 negative and 29 positive urine specimens were reevaluated at a third site and similar results were obtained.)

| | ACON One Step hCG Test Card | | | |
|---------------------|-----------------------------|----|-------|----|
| | + | - | Total | |
| BionexiaTM<br>Panel | + | 48 | 0 | 47 |
| | - | 0 | 47 | 47 |
| | Total | 48 | 47 | 95 |

(II) Sensitivity and Cross-reactivity

The Bionexia " hCG Pregnancy Test detects ß- Human Chorionic Gonadotropin at a concentration of 20mlU/ml or greater in urine specimen. The test has been standardized to the WHO Fourth International Standard 75/589.

Cross-reactivity study (Specificity) evaluated at negative (0 mIU/ml) and positive (20 mIU/ml) hCG specimens showed no cross-reaction:

| Substances (level) | % Non-cross-reactivity | | | | | | |
|--------------------|------------------------|--|--|--|--|--|--|
| hCG (20 mIU/ml) | 100% | | | | | | |
| hLH (300 mIU/ml) | .500% | | | | | | |
| hFSH (1000 mIU/ml) | 5.000% | | | | | | |
| hTSH (1.000 ulUmL) | 5% | | | | | | |

| | 0 | | 10 | | 12.5 | | 15 | | 17.5 | | 20 | | 25 | | 30 | | 35 | | 40 | | 100 | |
|--------------------|-----|---|-----|---|------|----|----|----|------|----|----|-----|----|-----|----|-----|----|-----|----|-----|-----|-----|
| Levels<br>(mIU/ml) | | | | | | | | | | | | | | | | | | | | | | |
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + |
| Lot 1 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Lot 2 | 25 | 0 | 25 | 0 | 19 | 6 | 10 | 15 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Lot 3 | 25 | 0 | 25 | 0 | 21 | 4 | 14 | 11 | 3 | 22 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Lot 4 | 25 | 0 | 25 | 0 | 24 | 1 | 9 | 16 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Total No. | 100 | 0 | 100 | 0 | 87 | 13 | 44 | 56 | 8 | 92 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |
| Percent. % | 100 | 0 | 100 | 0 | 87 | 13 | 44 | 56 | 8 | 92 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |

## (H) Reproducibility

## Conclusion:

Results of Accuracy, Reproducibility, and POL site studies demonstrated the substantial equivalency between ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests and the ACON One Step Pregnancy Urine Test panel. It is also demonstrated that ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are safe and effective in detecting human chorionic gonadotropin (hCG) in urine to aid in the early determination of pregnancy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 9 2007

Applied DNA Technologies, Inc. c/o Feng-Yu Lee Vice President of Operation 26251 Verona Place Mission Viejo, CA 92692

Re: k070921

> Trade Name: Bionexia hCG Pregnancy Cassette and Dipstick Tests Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) test system. Regulatory Class: Class II Product Code: JHI Dated: May 31, 2007 Received: June 01, 2007

Dear Feng-Yu Lee,

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 -

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 legally marketed predicate device results in a classification for your device and thus, perroits 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). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology 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 (if known): k070921

# Device Name: ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests

Indications For Use:

The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine at 20 mlU/mL and above to help in the early determination of pregnancy.

The test kits are for health care professionals use including professionals at physician's office labs (POLs).

For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

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