EASYCUP

K023823 · Zer Hitech · JHI · May 22, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023823
• Device Name: EASYCUP
• Applicant: Zer Hitech
• Product Code: JHI · Clinical Chemistry
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

This device is indicated for use for the early detection of pregnancy to measure HCG, a placental hormone, in urine. The Zer EasyCup is indicated for use for the early detection of pregnancy to qualitatively measure HCG, a placental hormone, in urine. It is intended to be sold over the counter (OTC) and for professional use, and to be used directly by consumers at home, doctor's offices, laboratories, and hospitals.

Device Story

EASYCUP is a rapid, one-step lateral flow immunoassay for qualitative detection of human Chorionic Gonadotropin (hCG) in urine. Device consists of a nitrocellulose membrane on a plastic backing; test line coated with anti-alpha hCG antibodies; control line coated with anti-mouse IgG; sample pad contains anti-beta hCG antibodies conjugated to colloidal gold. Urine sample migrates through the pad; if hCG concentration exceeds 20 mIU/ml, hCG binds to gold-conjugated anti-beta antibodies; complex migrates to test line where it is captured by anti-alpha antibodies, forming a pink line. Excess gold-conjugated antibodies bind to the control line, forming a second pink line to confirm test validity. Negative samples show no test line. Used by consumers at home or professionals in clinics/hospitals for early pregnancy detection.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and performance to the predicate device.

Technological Characteristics

Lateral flow immunoassay; nitrocellulose membrane on plastic backing; colloidal gold-conjugated anti-beta hCG antibodies; anti-alpha hCG capture antibodies; anti-mouse IgG control line. Qualitative visual readout. Sensitivity threshold: 20 mIU/ml hCG.

Indications for Use

Indicated for early pregnancy detection by qualitative measurement of HCG in urine. Intended for OTC and professional use in home, clinical, and laboratory settings.

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

• Surestep HCG Pregnancy test (K912801)

Submission Summary (Full Text)

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# 11023823

# 510(k) Summary As Required by 21 section 807.92 ( c )

| 1-Submitter Name: | Mansour Consulting LLC |
|---------------------------------------------------------------------|---------------------------------------------------------------------|
| 2-Address: | 1308 Morningside Park Dr<br>Alpharetta, GA 30022 USA |
| 3-Phone: | [phone] |
| 4-Fax: | [phone] |
| 5-Contact Person: | Jay Mansour |
| 6-Date summary prepared: | November 1st, 2002 |
| 7-Device Trade or Proprietary Name: | EASYCUP |
| 8-Device Common or usual name: | HCG EASYCUP PREGNANCY TEST |
| 9-Device Classification Name: | Radioimmunoassay, Human Chorionic<br>Gonadotropin (HCG) test system |
| 10-Substantial Equivalency is claimed against the following device: | Surasten HCG Pregnancy test from APPLIED BIOTECH INC |

- Surestep HCG Pregnancy test from 510k # K912801
### 11-Description of the Device:

hCG EASYCUP PREGNANCY TEST is a rapid one-step test for a visual qualitative detection of human Chorionic Gonadotropin (hCG) in urine. hCG (Human Chorionic Gonadotropin) is a glycoprotein hormone, secreted by the fertilized ovum shortly after fertilization. In normal pregnancies, hCG can be determined in urine as early as ten days following conception. hCG makes an excellent marker for the early detection of pregnancy, as it appears in urine soon after conception. Its concentration in urine increases rapidly during early gestational growth.

A nitrocellulose membrane is placed on a plastic backing. Two lines of antibodies are drawn on the membrane. One line, which is the test line, is coated with anti-x hCG. The other line, which serves as a control line, is pre-coated with anti-mouse IgG. A pad, soaked with anti-B hCG antibodies conjugated to colloidal gold particles, is placed on the membrane. Both sides of the membrane are covered with absorbing paper.

When the sample is positive (above 20 mIU/ml) the liquid moves through the pad of the anti-ß antibodies. The antibodies bind the B subunit of the hormone. This complex labeled with gold moves through the membrane. When it arrives to the anti-x antibodies capture the complex by the a subunit of the hormone. The test line then becomes pink. When the rest of the gold conjugated antibodies reach the control line, the antilodies capture, non specifically, the gold conjugated anti-B hCG antibodies, a second pink line is formed.

A negative sample (hCG below 20 mIU/ml) will not create a complex of gold labeled antibodies and hormone molecules, and no pink test line will form. A colored control line will always appear resulting from the viability of the antibodies.

#### 12-Intended use of the device:

This device is indicated for use for the early detection of pregnancy to measure HCG, a placental hormone, in urine.

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# 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

# 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is IDENTICAL to the predicate device.

| FDA file reference number | 510k #K912801 |
|-----------------------------------------------------|-----------------------------------------------------------------------------|
| Attachments inside notification<br>submission file | Appendix 2 printouts from<br>www.fda.gov: 510K and device<br>classification |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical (Not applicable) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

p7

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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 eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.

. NY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zer Hitech Ltd. Mr. Jay Mansour FDA/ISO Regulatory Consultant for Medical Devices Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022

Re: k023823

> Trade/Device Name: EASYCUP Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX, JHI Dated: April 25, 2003 Received: May 7, 2003

Dear Mr. Mansour:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): 510k #K023823

Device Name: EASYCUP

Indications for Use:

The Zer EasyCup is indicated for use for the early detection of pregnancy to qualitatively measure HCG, a placental hormone, in urine.

It is intended to be sold over the counter (OTC) and for professional use, and to be used directly by consumers at home, doctor's offices, laboratories, and hospitals.

Ian Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093823

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use ( i)

Over-the-Counter Use

Per 21 CFR 801.109

(Optional Format 3-10-98)