AIMSTICK PBD PREGNANCY

K974368 · Germaine Laboratories, Inc. · DHA · Jan 2, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974368
• Device Name: AIMSTICK PBD PREGNANCY
• Applicant: Germaine Laboratories, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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

Device Story

AimStick™ PBD Pregnancy is a lateral flow immunoassay for qualitative hCG detection in urine. Device consists of a test strip utilizing monoclonal and polyclonal antibodies. Operation involves dipping the strip into a urine specimen; capillary action draws the specimen along the membrane. hCG in the specimen binds to a colored conjugate; a colored band forms at the specimen zone if hCG is present (≥20 mIU/ml). A control zone band appears regardless of hCG presence to confirm procedural validity. Used by healthcare professionals in clinical settings to aid in pregnancy determination. Results are interpreted visually by the clinician based on the presence or absence of colored bands.

Clinical Evidence

Multi-center clinical evaluation compared AimStick™ PBD Pregnancy against another commercially available test using 150 urine specimens. Results showed 100% concordance (78 positive, 72 negative) between the two assays. Analytical sensitivity is 20 mIU/ml hCG, standardized to WHO Third International Standard. No cross-reactivity observed with hLH (300 mIU/ml), hFSH (1000 mIU/ml), or hTSH (1000 µIU/ml).

Technological Characteristics

Lateral flow immunoassay; utilizes monoclonal and polyclonal antibodies for hCG detection. Sensitivity threshold: 20 mIU/ml. Standardized to WHO Third International Standard. Form factor: test strip. No electronic components or software.

Indications for Use

Indicated for professional use to qualitatively identify 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.

Submission Summary (Full Text)

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*974368
JAN.2,1998

# "Summary of Safety & Effectiveness"

AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the 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 AimStick™ PBD Pregnancy and another commercially available test. The study included 150 urine specimens tested with both assays. The following results were found:

| | Positive Results | Negative Results |
| --- | --- | --- |
| AimStick™ | 78 | 72 |
| Commercially Available Test | 78 | 72 |

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

AimStick™ PBD 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 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.


Premarket Notification 510(k) Number

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JAN - 2 1998

Mr. Martin O'Connor
General Manager
Germaine Laboratories, Inc.
4203 Gardendale Center
Suite 230
San Antonio, TX 78229

Re: K974368
Trade Name: AimStick™ PBD Pregnancy
Regulatory Class: II
Product Code: DHA
Dated: November 18, 1997
Received: November 20, 1997

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 Regulations, 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 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 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

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: K 974368

Device Name: AimStick™ PBD Pregnancy

"Indications For Use" - AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.


(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (per 21 CFR 801.109)

or

Over-The-Counter Use

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