K Number
K023823
Device Name
EASYCUP
Manufacturer
Date Cleared
2003-05-22

(188 days)

Product Code
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 Description
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.
More Information

No
The device description details a rapid, one-step immunoassay based on antibody binding and visual detection of a colored line. There is no mention of computational analysis, algorithms, or learning processes.

No
The device is for the early detection of pregnancy by measuring HCG, which is a diagnostic purpose, not a therapeutic one. It does not provide treatment or ameliorate disease.

Yes
The device is described as being indicated for "early detection of pregnancy to measure HCG" and for "qualitatively measure HCG," which involves detecting a physiological condition (pregnancy) and is therefore a diagnostic function.

No

The device description clearly outlines a physical test strip with antibodies, a membrane, and absorbing paper, indicating it is a hardware-based diagnostic test, not software only.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device is for the "early detection of pregnancy to measure HCG... in urine." This involves testing a biological sample (urine) outside of the body to gain information about a physiological state (pregnancy).
  • Device Description: The description details a test that uses antibodies and a chemical reaction on a membrane to detect the presence of hCG in a urine sample. This is a classic method for in vitro diagnostic testing.
  • Qualitative Measurement: The device performs a "qualitative measure" of hCG, meaning it determines if hCG is present above a certain threshold (20 mIU/ml) rather than providing a precise numerical value. This is a common characteristic of many IVD tests, particularly rapid tests.
  • Sample Type: The test uses urine, which is a biological specimen.
  • Testing Location: While it can be used at home, it is also intended for use in professional settings like doctor's offices, laboratories, and hospitals, which are common locations for IVD testing.

Based on the provided information, the device clearly fits the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes

LCX, JHI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K912801

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.

0

11023823

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

1-Submitter Name:Mansour Consulting LLC
2-Address:1308 Morningside Park Dr
Alpharetta, GA 30022 USA
3-Phone:(678) 908-8180
4-Fax:(425) 795-9341
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
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.

Image /page/0/Picture/11 description: The image shows the number 6 inside of an oval shape. The number 6 is written in a simple, handwritten style. The oval shape is drawn with a thick, black line and encircles the number 6. The image is in black and white.

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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 number510k #K912801
Attachments inside notification
submission fileAppendix 2 printouts from
www.fda.gov: 510K and device
classification
TECHNOLOGICAL
CHARACTERISTICSComparison result
Indications for useIdentical
Target populationIdentical
DesignIdentical
MaterialsIdentical
PerformanceIdentical
SterilityIdentical (Not applicable)
BiocompatibilityIdentical
Mechanical safetyIdentical
Chemical safetyIdentical
Anatomical sitesIdentical
Human factorsIdentical
Energy used and/or deliveredIdentical
Compatibility with environment
and other devicesIdentical
Where usedIdentical
Standards metIdentical
Electrical safetyIdentical (not applicable)
Thermal safetyIdentical (not applicable)
Radiation safetyIdentical (not applicable)

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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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Page 2 -

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)


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)