AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST

K981165 · Germaine Laboratories, Inc. · JHI · Apr 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981165
• Device Name: AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
• Applicant: Germaine Laboratories, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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

Device Story

AimStep™ Combo Pregnancy is an in vitro diagnostic test for rapid qualitative detection of hCG in serum or urine. Device utilizes lateral flow immunoassay technology; specimen migrates via capillary action along a membrane. Test employs monoclonal and polyclonal antibodies to selectively detect hCG; positive results indicated by colored line formation in specimen area; procedural control line always appears. Designed for professional use in clinical settings. Provides rapid visual results to aid pregnancy determination. Detects hCG concentrations of 20 mIU/ml and greater; standardized to WHO Third International Standard. No cross-reactivity with hLH, hFSH, or hTSH.

Clinical Evidence

Multi-center clinical evaluation compared AimStep™ Combo Pregnancy against a commercially available predicate. Study included 159 urine specimens (71 positive, 88 negative) and 73 serum specimens (21 positive, 51 negative, 1 inconclusive). Results showed 100% concordance between the subject device and the comparator. Analytical testing confirmed sensitivity of 20 mIU/ml and no cross-reactivity with hLH (500 mIU/ml), hFSH (1000 mIU/ml), or hTSH (1000 ulU/ml).

Technological Characteristics

Lateral flow membrane immunoassay. Employs monoclonal and polyclonal antibodies for hCG detection. Detects hCG at concentrations ≥ 20 mIU/ml. Standardized to WHO Third International Standard. Visual readout via colored lines. Professional use format.

Indications for Use

Indicated for professional use to aid in the early determination of pregnancy by qualitatively identifying hCG in serum or urine specimens.

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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K981165

APR 1 6 1998

## "Summary of Safety & Effectiveness"

AimStep™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or 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 adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored coningate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

A multi-center clinical evaluation was conducted comparing the results obtained using AimStep™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. The following results were found:

| | Positive<br>Urine Results | Negative<br>Urine Results | |
|--------------------------------|---------------------------|---------------------------|-------------------------------|
| AimStep™ Combo | 71 | 88 | |
| Commercially<br>Available Test | 71 | 88 | |
| | Positive<br>Serum Results | Negative<br>Serum Results | Inconclusive<br>Serum Results |
| AimStep™ Combo | 21 | 51 | 1 |
| Commercially<br>Available Test | 21 | 51 | 1 |

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

AimStep™ Combo 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 (500 mIUml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.

Martin O'Connor Regulatory Affairs

3-30-98
Date

Martin O'Comer. Regulatory Affairs Germaine Laboratories. Inc. 4203 Gardendale Center, Suite 230 San Antonio, TX 78229 USA

Premarket Notification 510(k) Number

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 16 1590

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

Re : K981165 AimStep™ Combo Pregnancy Regulatory Class: II Product Code: JHI March 30, 1998 Dated: Received: March 31, 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, Druq, 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. ದ 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 regulatory action. In addition, FDA may publish further announcements 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 requlations.

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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 empirance at [phone]. preference 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:_

Device Name: AimStep™ Combo Pregnancy

And Antiques Company of the Comments of

AimStep™ Combo Pregnancy is intended for the rapid qualitative "Indications For Use" identification of hCG (human Chorionic Gonadotropin) in serum or 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)

| | <i>for</i> H. Montgomery |
|-----------------------------------------|--------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | A981165 |

| Prescription Use | | or | Over-The-Counter Use |
|----------------------|--|----|----------------------|
| (per 21 CFR 801.109) | | | |

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