(188 days)
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.
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.
This 510(k) summary describes the EASYCUP Pregnancy Test, intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection.
Here's an analysis of the provided information, addressing your specific questions:
1. A table of acceptance criteria and the reported device performance
The provided document does not specify quantitative acceptance criteria or explicitly report on performance studies for the EASYCUP device itself. Instead, it justifies substantial equivalence by stating that the "Performance" is "Identical" to the predicate device (Surestep HCG Pregnancy test from APPLIED BIOTECH INC, 510k # K912801).
Therefore, based solely on the provided text, there are no specific performance metrics or acceptance criteria stated for the EASYCUP. The claim is one of direct identity and substantial equivalence, not independent performance validation with criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on claiming "Identical" performance to the predicate device, implying that no separate performance study for the EASYCUP was conducted or presented in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no specific performance study for the EASYCUP is detailed, there's no mention of experts or ground truth establishment relevant to a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No test set or corresponding adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a rapid diagnostic test for hCG in urine, not an AI-assisted diagnostic tool that would involve human readers interpreting complex medical images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the context of this device. The EASYCUP is a device for detecting hCG, not an algorithm. Its performance is inherent in its chemical and biological components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided for the EASYCUP. For pregnancy tests, ground truth would typically be established by clinical follow-up or a reference laboratory method (e.g., quantitative serum hCG testing). However, since the submission claims "Identical" performance to a predicate, it implicitly relies on whatever ground truth was used for that predicate, which is not detailed here.
8. The sample size for the training set
This information is not provided. This device is not an AI/ML product developed with training sets.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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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 DrAlpharetta, 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 ChorionicGonadotropin (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 number | 510k #K912801 |
|---|---|
| Attachments inside notificationsubmission file | Appendix 2 printouts fromwww.fda.gov: 510K and deviceclassification |
| TECHNOLOGICALCHARACTERISTICS | 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 environmentand other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (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)
§ 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.