(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.
§ 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.