ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST

K032510 · ACON Laboratories, Inc. · LCX · Sep 22, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032510
• Device Name: ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Sep 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the 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.

Device Story

Qualitative immunochromatographic assay; detects hCG in urine. Device consists of absorbent fiber tip, result window, control window, and thumb grip. User places tip in urine stream or dips into collected sample; urine migrates via capillary action. hCG binds to anti-hCG-colored particle conjugate; forms colored line in test region if hCG present. Control line indicates valid test. Intended for home use by lay individuals. Provides visual qualitative result to aid in pregnancy determination.

Clinical Evidence

Consumer field study (n=113). Compared consumer performance against lab professional performance using subject device and predicate. Lab professionals achieved 100% concordance between subject and predicate (77 positive, 36 negative). Consumers achieved 100% negative agreement; 75/77 positive agreement with one discrepant and one invalid result. Demonstrates ability of lay users to perform test and interpret results.

Technological Characteristics

Qualitative solid-phase sandwich-format immunochromatographic assay. Materials include absorbent fiber tip and membrane. Sensitivity 25 mIU/mL. Standardized to WHO 3rd International Standard. No electronic components or software.

Indications for Use

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

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 Midstream Pregnancy Test (K983090)

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 K032510.

# Device Names:

ACON Quik-Check II Midstream Home Pregnancy Test

## Common Name:

Pregnancy Test Kit, Over-the-Counter

## Classification Name:

Gonadotropin

# Name of the Predicate Device

ACON Midstream Home Pregnancy Test (K983090)

# 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 applying urine sample through urination, or dipping test device into collected urine sample, and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device 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".

The ACON Quik-Check II Midstream Home Pregnancy Test 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 crossreactivity.

## Intended Use:

The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the 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.

## Clinical Studies:

Clinical studies were conducted to compare the results of ACON Quik-Check II Midstream home Pregnancy Test to the current ACON Midstream Pregnancy Test (K983090). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two midstream 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 midstream hCG tests. The results also showed that the vast majority of the participants found ACON Ouik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

#### Additional Study 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 Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions.

The overall performance data indicate that ACON Quik-Check II Midstream Home Pregnancy Test (Home Tests) is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K983090) currently on the U. S. OTC market.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white circular logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle. Inside the circle is a symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

SEP 2 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k032510

Trade/Device Name: ACON Quik-Check II Mainstream 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: September 5, 2003 Received: September 11, 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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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 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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#### Indications For Use V.

510(k) Number: K032510

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

- The ACON Quik-Check II Midstream Home Pregnancy Test is a "Indications for Use": qualitative test for the detection of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

KO32510 510(k).

(Please do not write below this point)

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

or

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(per 21 CFR 801.109)