PREGNACOL PREGNANCY TEST

K972606 · Immunostics Inc., · JHJ · Aug 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972606
• Device Name: PREGNACOL PREGNANCY TEST
• Applicant: Immunostics Inc.,
• Product Code: JHJ · Clinical Chemistry
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The PREGNACOL PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.

Device Story

Pregnacol Pregnancy Test is a rapid, direct, color-enhanced latex slide agglutination assay. It detects elevated human chorionic gonadotropin (hCG) levels in patient samples. Used in clinical and hospital laboratories by trained laboratory personnel. Principle of operation involves latex particles coated with anti-hCG antibodies; agglutination occurs in the presence of hCG, providing a visual qualitative or semiquantitative result. Assists clinicians in early pregnancy diagnosis.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Latex slide agglutination assay; color-enhanced latex particles coated with anti-hCG antibodies. Qualitative and semiquantitative detection method. In vitro diagnostic reagent.

Indications for Use

Indicated for the qualitative and semiquantitative detection of elevated human chorionic gonadotropin (hCG) levels in individuals to aid in the early diagnosis of pregnancy. Intended for use in clinical and hospital laboratory settings; not for doctor office use.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David Mycock Laboratory Director Immunostics, Inc. 3505 Sunset Avenue Ocean, New Jersey 07712 - ----

AUG 2 9 1997

Re : K972606/S1 Immunostics, Inc., Pregnacol™ Pregnancy Test Trade Name: Regulatory Class: II Product Code: JHJ Dated: August 7, 1997 Received: August 11, 1997

Dear Mr. Mycock:

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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFK 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 Autman

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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Quality Microbiological, Serological and Immunological Reagents

K972600 510(k) Number (if known):

Device Name:_

PREGNACOL™PREGNANCY TEST

Indications for Use: . . . . .

The PREGNACOL PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

OR

Over-the-Counter Use_

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | k972606 |

3505 Sunset Avenue, Ocean, New Jersey 07712 • 732-918-0770 • FAX [phone]

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