AIMSTEP PREGNANCY

K980531 · Germaine Laboratories, Inc. · JHI · Mar 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980531
• Device Name: AIMSTEP PREGNANCY
• Applicant: Germaine Laboratories, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Mar 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

AimStep Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

Device Story

AimStep Pregnancy is a lateral flow immunoassay test strip; detects hCG in urine samples. Principle of operation: capillary action moves specimen along membrane; monoclonal and polyclonal antibodies react with hCG to form colored bands. Output: visual colored band on test strip indicating presence (positive) or absence (negative) of hCG; procedural control band confirms test validity. Used in clinical settings by healthcare professionals. Provides rapid qualitative results to aid in pregnancy determination. Benefits patient through early pregnancy detection.

Clinical Evidence

Multi-center clinical evaluation comparing AimStep Pregnancy to a commercially available test. Study included 148 urine specimens. Results showed 100% concordance (64 positive, 84 negative) between the two assays.

Technological Characteristics

Lateral flow immunoassay test strip. Utilizes monoclonal and polyclonal antibodies. Detects hCG concentrations of 20 mIU/ml and greater. Standardized to WHO Third International Standard. No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), or hTSH (1000 ulU/ml).

Indications for Use

Indicated for professional use for the qualitative identification of hCG in urine to aid in the early determination of pregnancy.

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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K980531

## "Summary of Safety & Effectiveness"

## MAR - 6 1998

AimStep Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

A multi-center clinical evaluation was conducted comparing the results obtained using AimStep™ Pregnancy and another commercially available test. The study included 148 urine specimens tested with both assays. The following results were found:

| | Positive Results | Negative Results |
|--------------------------------|------------------|------------------|
| AimStep™ | 64 | 84 |
| Commercially<br>Available Test | 64 | 84 |

AimStep™ Pregnancy showed a 100% concordance with the other commercially available test.

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

Whate O'Conne
Martin O'Connor, Regulatory Affairs

Martin O'Connor, Regul Germaine Laboratories. In 4203 Gardendale Center, Suite 230

2-9-98
Date

Premarket Notification 510(k) Number

Page 1 of 17

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 6 1998

Martin O'Connor . General Manager Germaine Laboratories, Inc. 4203 Gardenale Center Suite 230 San Antonio, Texas 78229

Re : K980531 AimStep™ Pregnancy Regulatory Class: II Product Code: JHI February 9, 1998 Dated: Received: February 11, 1998

Dear Mr. O'Connor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 additionally 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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

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 Use

510(k) Number: k980631

Device Name: AimStep™ Pregnancy

"Indications For Use" -

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

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*
Division of Clinical Laboratory Devices

Prescription Use
(per 21 CFR 801.109)

or

Over-The-Counter-Use