AIMSTEP PREGNANCY

K013857 · Germaine Laboratories, Inc. · DHA · Jan 22, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013857
• Device Name: AIMSTEP PREGNANCY
• Applicant: Germaine Laboratories, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Device Story

AimStep™ Pregnancy is a lateral flow immunoassay for home pregnancy testing. Input: urine specimen. Principle: capillary action moves specimen along a membrane; hCG reacts with monoclonal and polyclonal antibody reagents conjugated to colloidal gold particles. Output: visual colored pink line in the 'Test Region' indicates hCG presence (≥20 mIU/ml); a colored line in the 'Control Region' confirms procedural validity. Used by consumers in home settings. Results interpreted visually by the user to aid in pregnancy determination.

Clinical Evidence

Clinical trial comparing AimStep™ Pregnancy to Clearview™ Easy HCG Pregnancy Test with 137 female participants. Results demonstrated >99% accuracy/correlation between the two tests. Usability assessment indicated participants found the device easy to use, with no difficulty understanding labeling, instructions, or interpreting results.

Technological Characteristics

Lateral flow immunoassay; colloidal gold-labeled antibody conjugate; membrane-based antibody capture; detects hCG at 20 mIU/ml; standardized to WHO Third International Standard; no cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), or hTSH (1000 µIU/ml).

Indications for Use

Indicated for non-professional, over-the-counter use by individuals to qualitatively detect 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

• Clearview™ Easy HCG Pregnancy Test

Submission Summary (Full Text)

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## JAN 2 2 2002

## "Summary of Safety & Effectiveness"

K013857

The AimStep™ Pregnancy (Home Test) is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.

The AimStep™ Pregnancy icst detects hCG concentrations of 20 mlU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.II (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µ1U/ml) to negative (0 mIJ/ml hCG) and positive (20 mlU/ml h(.C) urine showed no cross-reactivity.

A clinical trial was conducted comparing the results of AimStep™ Pregnancy to the Clearview™ Easy HCG Pregnancy Test. The study included 137 female participants and demonstrated an accuracy of over 99% correlation between the 2 tests. The results also showed that the majority of the participants found AimSten™ Pregnancy very casy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

AimStep™ Pregnancy and the Clearvicw™ Easy 11CG Pregnancy Test use the following similar methodologies and components:

- a) Dry particle coated with anti-hCCi which reacts with the specimen
- b) Specimen migrates on a membrane coated with antibodies
- c) A colored line appears in a Test Region to indicate a positive result
- d) A colored line appears in a Control/Reference Region to indicate the test is completed and has worked correctly

AimStep™ Pregnancy and Clearview™ Easy HCG Pregnancy Test use the following different methodologies and components:

- a) AimStep™ Pregnancy uses a colloidal gold particle and the predicate device uses a blue latex particle
- b) AimStep™ Pregnancy produces a Pink colored line in the Test and Control Zones and the predicativ device produces a Blue colored line in the Test and Reference region.

The overall results of the clinical trial confirm that AirnStep™ Pregnancy (Home Test for over the counter pregnancy testing

Martin O'Connor, Regulatory Affairs

Date

Premarket Notification 510(k) Number

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Martin O'Connor Regulatory Affairs Germaine Laboratories, Inc. 4139 Gardendale Center, Suite 101 San Antonio, TX 78229

JAN 2 2 2002

k013857 Trade/Device Name: AimStep™ Pregnancy Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: November 20, 2001 Received: November 21, 2001

Dear Mr. O'Connor:

Re:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 11 you dolly 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Usc

510(k) Number: K013857

Device Name: AimStep™ Pregnancy

"Indications For Use" -

AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Can Coope

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Division of Clinical Laboratory Devices
510(k) Number K013857

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Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use (pcr 21 CFR 801.109)

Over-The-Counter Use

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