ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP

K033041 · ACON Laboratories, Inc. · LCX · Nov 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033041
• Device Name: ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON Quik-Check II Home Pregnancy Test Strip is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

Device Story

The ACON Quik-Check II is a lateral flow immunoassay strip for home pregnancy testing. The device uses a combination of mouse monoclonal and goat polyclonal antibodies with a streptavidin-biotin ligand-binding system to detect hCG in urine. The user dips the strip into a urine sample; capillary action draws the specimen across the membrane. If hCG is present (at or above 25 mIU/mL), it binds to colored-particle-conjugated antibodies, forming a visible line in the test (T) region. A control (C) line confirms proper wicking and sample volume. The user visually interprets the presence or absence of lines to determine results. The device provides a qualitative result to aid in pregnancy determination.

Clinical Evidence

Consumer field study (n=113) compared consumer and lab professional performance against predicate. Lab professionals showed 100% agreement (75/75 positive, 38/38 negative). Consumers showed high accuracy: 72/75 positive (1 discrepant, 2 invalid) and 36/38 negative (2 invalid). Analytical testing confirmed 25 mIU/mL sensitivity and no cross-reactivity with LH, FSH, or TSH.

Technological Characteristics

Qualitative solid-phase sandwich-format immunochromatographic assay. Uses rabbit and goat antibodies. Standardized to WHO 3rd International Standard. Sensitivity 25 mIU/mL. Storage 15-30°C. Manual test strip form factor.

Indications for Use

Indicated for qualitative detection of elevated human Chorionic Gonadotropin (hCG) in urine to aid in pregnancy determination. Intended for non-professional, over-the-counter use by individuals seeking pregnancy status.

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 Pregnancy Test (K993483)

Submission Summary (Full Text)

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## III. 510(k) Summary

"This summary of 510(k) safety and effective ness information is being submitted in accordance with the regulation of SMDA 1990 and 21 CFR 807.92"

"The assigned 510(k) number is KO3304 | "

Device Names:

ACON Quik-Check II Home Pregnancy Test Strip

## Common Name:

Pregnancy Test Kit, Over-the-Counter

#### Classification Name:

Gonadotropin

#### Name of the Predicate Device

ACON Home Pregnancy Test Strip (K993483)

#### Medical Specialty:

Clinical Chemistry

#### Device Description:

The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by dipping the test strip into the urine sample that has been collected in a cup or clean, dry container and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test strip to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane.

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A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". Therefore, two colored line show up on the test strip indicating a positive result; one line shows up near the wicking end indicating a negative and one line shows up away from the wicking end indicating an invalid result.

The ACON Quik-Check II Home Pregnancy Test Strip qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/mL. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 IU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine showed no cross-reactivity.

#### Intended Use:

The ACON Quik-Check II Home Pregnancy Test Strip is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.

#### Clinical Studies:

Clinical studies were conducted to compare the results of ACON Quik-Check II Home Pregnancy Test Strip to the current ACON Home Pregnancy Test (K993483). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two Strip hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two Strip hCG tests. The results also showed that the vast majority of the participants found ACON Quik-Check II Home Pregnancy Test Strip very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

#### Additional Laboratory Studies to Establish Substantial Equivalence:

Additional laboratory study results on performance include specificity, interference substances. urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Home Pregnancy Test Strip is robust and will give accurate results under many adverse conditions.

The overall performance data indicate that ACON Ouik-Check II Home Pregnancy Test Strip is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K993483) currently on the U. S. OTC market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three wavy lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 1 2003

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories. Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121

Re: k033041

> Trade/Device Name: ACON Quik-Check II Home Pregnancy Test Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 26, 2003 Received: September 29, 2003

Dear Dr. Tung:

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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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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

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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#### V. Indications For Use

# 510(k) Number: K03 304 )

Device Name: ACON Quik-Check II Home Pregnancy Test Strip

- The ACON Quik-Check II Home Pregnancy Test Strip is for the "Indications for Use": qualitative detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.
Alberto Cutin
***_***_, Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033041.

(Please do not write below this point)

Concurrence of CDRH, Office of the In vitro Diagnostic Device Evaluation and Safety

Prescription Use

V Over-The-Counter Use

(per 21 CFR 801.109)

or