BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC

K071030 · Applied Dna Technologies, Inc. · JHI · Jun 29, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071030
• Device Name: BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
• 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 Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen 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 serum or urine. Device consists of reagent strips in cassette or dipstick formats; membrane coated with mouse monoclonal anti-alpha-hCG antibody; dried chemical pad contains colloidal gold-conjugated mouse monoclonal anti-beta-hCG antibody; control line uses goat anti-mouse IgG. Used in physician office labs or clinical settings by healthcare professionals. Visual interpretation of test lines indicates presence of hCG. Results aid in early pregnancy determination; requires confirmatory testing for final diagnosis. Benefits include rapid, point-of-care assessment of pregnancy status.

Clinical Evidence

Bench testing only. Analytical performance evaluated via precision/reproducibility studies (n=75 per level for dipstick, n=25 for cassette) across hCG concentrations (0-100 mIU/mL). Specificity confirmed against hLH, hFSH, hTSH, and common interfering substances. Hook effect study showed no interference up to 2 million mIU/mL. Method comparison study conducted at 3 clinical sites comparing subject device to predicate using 95 serum and 94 urine samples; demonstrated 100% agreement.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Components: reagent strip with anti-alpha hCG capture antibody-coated membrane and colloidal gold-labeled mouse anti-beta hCG monoclonal antibody. Form factors: cassette and dipstick. Storage: 2–30 °C. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of hCG in serum or urine to aid in early pregnancy determination in patients. For use by healthcare professionals, including those in physician 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

• ACON One Step hCG Urine/Serum Test (k041946)

Submission Summary (Full Text)

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

#### The Assigned 510(k) number is k071030

JUN 2 9 2007

Date of Summary: June 26, 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 Serum/Urine Cassette and Dipstick Tests

## Description:

The Bionexia™ hCG Pregnancy Serum/Urine Test are distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-u-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 Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen 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/Serum Test is used as predicate device for ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests to compare their performance of required studies.

510(k) number for predicate devices is:

ACON One Step Pregnancy Urine/Serum Test

K 041946

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# Performance:

The product performance characteristics of ADT's Bionexia™ hCG Pregnancy Serum/Urine 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 Serum/Urine Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine/Serum Test.

(I) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical serum specimens and 94 clinical urine specimens evaluated, the study were conducted at two POL sites. (Additionally, 20 negative and 29 positive serum & urine specimens were reevaluated at a third site and similar results were obtained.)

#### 1. Serum sample

| | ACON One Step hCG Urine/Serum Test Card | | | |
|-------------------------|-----------------------------------------|----|-------|----|
| | + | - | Total | |
| <i>BionexiaTM</i> Panel | + | 48 | 0 | 48 |
| | - | 0 | 47 | 47 |
| | Total | 48 | 47 | 95 |

# 2. Urine sample

| | ACON One Step hCG Urine/Serum Test Card | | | |
|----------------------------|-----------------------------------------|----|-------|----|
| | + | - | Total | |
| <i>BionexiaTM</i><br>Panel | 47 | 0 | 47 | |
| | 0 | 47 | 47 | |
| | Total | 47 | 47 | 94 |

# (II) Sensitivity and Cross-reactivity

The Bionexia" hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20mIU/ml or greater. 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) | 1,500% |
| hFSH (1000 mIU/ml) | 5,000% |
| hTSH (1,000 µIU/mL) | 5% |

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# (III) Reproducibility

| Levels<br>(mIU/ml) | 0 | | 10 | | 12.5 | | 15 | | 17.5 | | 20 | | 25 | | 30 | | 35 | | 40 | | 100 | |
|--------------------|-----|---|-----|---|------|----|----|----|------|----|----|-----|----|-----|----|-----|----|-----|----|-----|-----|--|
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | | |
| Lot 1 | 25 | 0 | 25 | 0 | 20 | 5 | 11 | 14 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Lot 2 | 25 | 0 | 25 | 0 | 22 | 3 | 14 | 11 | 4 | 21 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Lot 3 | 25 | 0 | 25 | 0 | 21 | 4 | 12 | 13 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Lot 4 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Total No. | 100 | 0 | 100 | 0 | 86 | 14 | 48 | 52 | 9 | 91 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | | |
| Percent. % | 100 | 0 | 100 | 0 | 86 | 14 | 48 | 52 | 9 | 91 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | | |

#### Table 1: Serum controls

## Table 2: Urine controls

| Levels<br>(mIU/ml) | 0 | | 10 | | 12.5 | | 15 | | 17.5 | | 20 | | 25 | | 30 | | 35 | | 40 | | 100 | |
|--------------------|-----|---|-----|---|------|----|----|----|------|----|----|-----|----|-----|----|-----|----|-----|----|-----|-----|--|
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | | |
| Lot 1 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Lot 2 | 25 | 0 | 25 | 0 | 19 | 6 | 12 | 13 | 1 | 24 | 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 | | |
| Lot 4 | 25 | 0 | 25 | 0 | 24 | 1 | 9 | 16 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | | |
| Total No. | 100 | 0 | 100 | 0 | 87 | 13 | 46 | 54 | 7 | 93 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | | |
| Percent. % | 100 | 0 | 100 | 0 | 87 | 13 | 46 | 54 | 7 | 93 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | | |

#### Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUN 2 9 2007

k071030 Trade/Device Name: Bionexia™ hCG Pregnancy Serum/Urine 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: March 25, 2007 Received: April 11, 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 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). 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 vours.

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

Séan 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): k071030

# Device Name: ADT's Bionexia" hCG Pregnancy Serum/Urine Cassette and Dipstick Tests

Indications For Use:

The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen at 20 mIU/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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510(k) K07/030