UNIMARK HCG COMBO PREGNANCY TEST

K013194 · Biotech Atlantic, Inc. · JHI · Oct 10, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013194
• Device Name: UNIMARK HCG COMBO PREGNANCY TEST
• Applicant: Biotech Atlantic, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Oct 10, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

UniMark® hCG Combo Pregnancy Test (Strip and Device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

Device Story

Chromatographic immunoassay for qualitative hCG detection in serum/urine; used for early pregnancy diagnosis. Specimen migrates via capillary action through conjugate pad containing mouse anti-beta hCG antibodies on colloidal gold; captured by immobilized goat anti-hCG antibodies at test zone. Positive result indicated by purple band; control band confirms validity. Intended for professional/laboratory use. Addition of normal mouse IgG in sample pad blocks non-specific binding sites to minimize false positives in serum. Output is visual qualitative assessment of pregnancy status.

Clinical Evidence

Bench testing only. Performance characteristics including sensitivity, accuracy (correlation), specificity, and interference testing were evaluated using both serum and urine specimens. Accuracy and sensitivity were compared against the SureStep hCG Combo Pregnancy Test.

Technological Characteristics

Chromatographic immunoassay (lateral flow). Components: conjugate pad with colloidal gold-labeled mouse anti-beta hCG antibodies, membrane with immobilized goat anti-hCG antibodies. Includes normal mouse IgG for serum interference mitigation. Form factor: test strip or strip within plastic holding device. Professional/laboratory use.

Indications for Use

Indicated for the early detection of pregnancy in professional and laboratory settings using 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.

Predicate Devices

• UniMark® hCG Pregnancy Test (K941090)

Reference Devices

• SureStep hCG Combo Pregnancy Test

Submission Summary (Full Text)

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K013194

#### 510(k) SUMMARY OF INFORMATION RESPECTING SAFETY AND 11. EFFECTIVENESS

## A. Name and Address of Submitter

| Company Name and Address: | Biotech Atlantic, Inc.<br>6 Industrial Way West<br>Eatontown, NJ 07724 |
|---------------------------|------------------------------------------------------------------------|
| Telephone | 732-389-4789 |
| FAX: | 732-389-3837 |
| Contact Person: | Francis Lee |

## B. Device Names

| Proprietary Name: | UniMark® hCG Combo Pregnancy Test |
|----------------------|------------------------------------------------|
| Common Name: | hCG Pregnancy Test |
| Classification Name: | Human Chorionic Gonadotropin (hCG) Test System |

## C. Legally Marketed Device

UniMark® hCG Pregnancy Test, K941090

## D. Device Description

UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.

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## E. Intended Use

UniMark® hCG Combo Pregnancy Test (Strip and Device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

# F. Comparison with Predicate Device

The UniMark® hCG Combo Pregnancy Test (Strip and Device) is the same as the UniMark® hCG Pregnancy Test (Strip and Device) with the following exceptions:

- UniMark® hCG Combo Pregnancy Test is intended for use with both l serum and urine specimens; the UniMark® hCG Pregnancy Test is intended for use with urine specimens only
- UniMark® hCG Combo Pregnancy Test contains an additional reagent, ﺳ normal mouse IgG, in the sample pad to block the nonspecific binding sites of the proteins or antibodies in a serum sample. This minimizes the potential for false positive readings when serum samples are tested.

## G. Performance Data

The performance characteristics of the UniMark® Combo hCG Pregnancy Test (Strip and Device) are provided in the package insert, and included sensitivity, accuracy (correlation), specificity, and interference testing with both serum and urine specimens. Sensitivity and accuracy studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech.

# H. Conclusions Drawn from the Studies

The conclusions drawn from the performance studies demonstrate that the UniMark® Combo hCG Pregnancy Test is as safe, effective, and performs as well as the legally marketed device to which equivalence is claimed, the UniMark® hCG Pregnancy Test when tested with urine specimens. Further, the sensitivity and accuracy of the UniMark® Combo hCG Pregnancy Test demonstrate that the test is as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 0 2001

Mr. Francis Lee Chief Executive Officer Biotech Atlantic, Inc. Meridan Center III Bay F. 6 Industrial Way West Eatontown, NJ 07724

Re: k013194

Trade/Device Name: UniMark ® hCG Combo Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 24, 2001 Received: September 25, 2001

Dear Mr. Lee:

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 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" (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 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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## STATEMENT OF INDICATIONS FOR USE

UniMark® hCG Combo Pregnancy Test

UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.

It is indicated for use in the early detection of pregnancy.

## Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_1

OR

Over-the-Counter-Use

Per 21 CFR 801.109

(Optional Format 1-2-96)

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ 1 0 13 1914

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