ACON +/- MIDSTREAM PREGNANCY TEST

K050546 · ACON Laboratories, Inc. · LCX · May 20, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050546
• Device Name: ACON +/- MIDSTREAM PREGNANCY TEST
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter use.

Device Story

The ACON +/- Midstream Pregnancy Test is a lateral flow immunoassay for qualitative hCG detection in urine. It utilizes a color particle sandwich binding principle. The device incorporates a moisture-sensitive dye pad that changes from colorless to colored upon contact with urine, forming a '+' or '-' pattern in the result window to indicate pregnancy status. A separate control window displays a red line to confirm adequate sample volume and proper wicking. The device is intended for over-the-counter home use by lay persons. Users interpret the visual '+' or '-' result to determine pregnancy. The test has a cutoff sensitivity of 25 mIU/mL hCG. It provides a rapid, qualitative assessment to aid in pregnancy determination.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modification meets predetermined acceptance criteria.

Technological Characteristics

Lateral flow immunoassay; color particle sandwich binding; moisture-sensitive dye pad for visual '+' or '-' result indication; control line for procedural validity; cutoff sensitivity 25 mIU/mL hCG; standardized to WHO 4th International Standard; non-interfering with LH (300 mIU/mL), FSH (1,000 mIU/mL), or TSH.

Indications for Use

Indicated for use as a diagnostic test device; patient population and specific disease state not explicitly defined in provided documentation.

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.

Submission Summary (Full Text)

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K050546

## MAY 2 0 2005

# 510(k) Summary

## Device Names:

ACON +/- Midstream Pregnancy Test

#### Common Name:

Pregnancy Test Kit, Over-the-Counter

# Classification Number:

862.1155

## FDA Product Code:

LCX

#### Medical Specialty:

Clinical Chemistry

#### Intended Use:

The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic The ACON 17- Midstrain Programs) - Fees to to to to to to to to of pregnancy. It is for over-the-counter use.

#### Device Description:

ACON +/- Midstream Pregnancy Test is a modified device from the previously FDA-cleared ACON ACON +/- Mustleann Fregnancy Test is a The immunochemical formulation, which employs an Midsleam Tregnancy Color particle sandwich binding, lateral flow immunoassay for the detection of hCG, remains the same for the modified device. With the incorporation of a proprietary moisture-sensitive dye pad within the test strip, an additional test line perpendicular to the regulation thoisture-sellsitive dyc pac willin the test bevice. The moisture-sensitive dye pack to treasur the test the will develop for the mounted test connect by urine sample. Regardless of the test result, this change from coloness to pinnered color with the user. While the un-modified device will have a colored test line developed in the result window for positive result and no colored line for negative colored test inte developed in the result willion to press. "+" pattern in the result window for positive result, and a colored "-" pattern for negative result.

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Therefore, a colored "+" sign forms in the result window indicates a possive ers a presedured I nerelore, a colored - - sign in the result window indicates a negative result. To serve as a procedural presence of a - - sigli in the result window indicating adequate sample volume and control, a red inte will always appeal in the control winessample. The absence of the redition proper wicking, regardless or the presence or the mind is "invalid". For the modified cost result avon control mic of a horizontal line in the result window also constitutes an "invalid" test result even there is a red line present in the control window.

The ACON +/- Midstream Pregnancy Test qualitatively detects hCG in urine sample with a The ACON 7/- Midstrom Pregnancy - C mIU/mL. The cutoff concentration of this test has been designated colloir the World Health Organization Fourth International Standard for Chorionic Standardized to the World Treath Organized of LH (300 mIU/mL), FSH (1,000 mU/mL), or Ochadouvpll (NHDSC Code: 1970271 ve (0 mIUmL hCG) or positive (25 mIU/mL hCG) urine samples did not interfere in correctly reading of the expected test result.

# Clinical Study:

A device readability study using the ACON +/- Midstream Pregnancy Test by participants with no A device readability study assilg the 1 Occuracy of over 99% (2.59/260 with 95% confidence interval of 97.9-99.9%), indicating that the vast majority of lay persons are able to correctly read and interpret the test results following the package insert's instructions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 0 2005

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

k050546 Re:

R050540
Trade/Device Name: ACON +/- Midstream Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 2, 2005 Received: May 3, 2005

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manatist date of the Medical Device Advanced Ford Deva commerce provision of May 20, 1976, the enated with the provisions of the Federal Food. Drug, devices that have been reclassified in acceraaned what a premarket approval application (PMA). allo Cosmenc Act (Act) that do not require to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 a00 v) arols. Existing major regulations affecting your device and diving and this a It may be subject to such additional controllations (CFR), Parts 800 to 895. In addition, FDA can oc louid in This 21, Cour Crice oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a backers. In the requirements of the Act
that FDA has made a determination that your device complies with other requirements of th that I DA has made a decornmancing administered by other Federal agencies. You must of any Federal Statules and regulations daminities. or registration and listing (21 comply with an the Ace 31equirements 801 and 809); and good manufacturing practice to CFR Fall 607), labeling (21 CF ruality 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) I his letter will allow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA miding of Subscances quarterice and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of In If you desire specific information acourt is appear device, please contact the Office of In
or questions on the promotion and advertising of your and advertising of the or questions on the promotion and acreening commitments on your consection of [phone] Vitro Diagnostic Device Livanianon and Barey and (210). (210FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification Ast from the You may obtain other general information on your responsibilities under the Act from the You may of all other general information on Jour responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: ACON +/- Midstream Pregnancy Test

- The ACON +/- Midstream Pregnancy Test is intended for over-the-counter "Indications for Use": use for the qualitative identification of the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 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)

Rutea Chulen

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number.

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