(233 days)
Home pregnancy test kits can now be purchased from most drug stores without a prescription.
One step Best midstream presnancy test kids detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG.
Here's an analysis of the provided text in the context of acceptance criteria and study design, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Pregnant women) | 100% |
| Cross-reactivity with LH (at <200 mIU/ml) | Negative |
| Substantial Equivalence to "Be sure" one step midstream pregnancy test kits (FDA-approved) | Performance "very similar" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the accuracy study or for the comparison with the "Be sure" kit. It only mentions "laboratory test" for the 100% accuracy claim.
The data provenance is not explicitly stated (e.g., country of origin). It's implied to be retrospective as it refers to a "laboratory test" and a comparison of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The text does not mention the involvement of experts in establishing the ground truth for the accuracy or cross-reactivity tests.
4. Adjudication Method for the Test Set
This information is not provided in the document. No 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
There is no indication of an MRMC comparative effectiveness study in the provided text. This device is a standalone diagnostic kit, not an AI-assisted tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this device is inherently a standalone diagnostic. The reported performance (100% accuracy, negative cross-reactivity) is for the device operating independently without human interpretation beyond reading the visual result.
7. The Type of Ground Truth Used
The type of ground truth used is implied to be:
- Actual pregnancy status (for the 100% accuracy claim) – presumably confirmed by clinical means, though not specified.
- Known LH levels (for the cross-reactivity claim).
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device. The document describes a traditional immunoassay.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is not an AI/machine learning device with a training set. The "ground truth" for the device's design and validation would stem from established medical understanding of HCG and LH levels in relation to pregnancy.
Critique and Missing Information Based on the Request:
The provided text offers very limited detail about the study methodology. For a comprehensive understanding of the device's validation and to meet the detailed requirements of your request, much more information would be needed, specifically regarding:
- Specific sample sizes for all reported tests (accuracy, cross-reactivity, and comparison).
- Demographics and characteristics of the test population(s).
- Exact methodology of the "laboratory test" that yielded 100% accuracy.
- How actual pregnancy status was confirmed (the "ground truth").
- Details of the comparison study with the "Be sure" kit (e.g., sample size, specific metrics used to determine "very similar" performance).
- Any adverse events or limitations identified during testing.
- Statistical methods used to determine significance and similarity.
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Summary
Home pregnancy test kits can now be purchased from most drug stores without a prescription. There are approximately more than 10 various kinds of one step home pregnancy test kits available. These tests are virtually the same as the urine pregnancy tests performed in most doctoral office and clinics. The home pregnancy tests are convenient, private, and, if performed properly, can be quite accurate.
During pregnancy a fertilized egg implanted in the uterus wall, A hormone, called human choroinic gonadotropin (HCG) is then produced by the developing placenta and excreted in the urine. The amount of HCG excreted in the urine rises rapidly during the first weeks of pregnancy. Home pregnancy tests are designed to detect this pregnancy hormone in woman urine.
One step Best midstream presnancy test kids detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG. .
The test kit accuracy for pregnant women are 100% in laboratory test. The cross reactivity with LH is negative when LH level is less than 200 mIU/ml.
The data of our test kits compared with "Be sure" one step midstream pregnancy test kits, which were approved by FDA, indicates that the performance of both kits are very similar. Substantial equivalence should be determined.
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§ 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.