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solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum.
Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Excel OneStep Urine/Serum hCG Module Pregnancy Test:
Given the nature of the document (a "Summary of Safety and Effectiveness" from 1996 for a pregnancy test), it's important to note that the level of detail regarding study design and ground truth establishment will be significantly less comprehensive than what is typically expected for modern AI/ML device submissions. This document predates the widespread use of the detailed study design elements you've requested for AI/ML devices.
I will extract the information that is present and indicate when specific details are not provided in the document.
Acceptance Criteria and Reported Device Performance
The provided text describes the functional differences and cut-off for the Excel OneStep Urine/Serum hCG Module Pregnancy Test compared to a predicate device (Syntron Quikpac I EIA). It implies that the Excel OneStep device should perform at least as well as the predicate for qualitative determination of hCG at the 25 mIU/mL threshold. While explicit numerical acceptance criteria (e.g., sensitivity, specificity thresholds) are not stated in a formal table, the core performance criterion is the reliable detection of hCG at or above 25 mIU/mL.
| Acceptance Criteria (Implied) | Reported Device Performance (Excel OneStep) |
|---|---|
| Qualitative determination of hCG in urine or serum. | Functions as a sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay for qualitative determination of hCG. |
| Cut-off for positive result at 25 mIU/mL. | Produces a pink-rose color band when hCG concentration is equal to or greater than 25 mIU/mL. |
| Absence of color for negative results. | In the absence of hCG, no colored line will appear in the positive reaction zone. |
| Functioning control mechanism. | Produces a pink-rose color band in the control zone, demonstrating that the reagent and device are functioning correctly. |
| Performance comparable to the Syntron Quikpac I EIA predicate device. | (Specific comparative performance metrics are not given in this summary, but the document is for regulatory approval implying acceptable performance.) |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document is a regulatory submission, so it implies a study was conducted, likely prospective, but details are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For a qualitative immunoassay, ground truth would typically be established by a reference method (e.g., quantitative laboratory assay) rather than expert interpretation of the test itself.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a rapid qualitative immunoassay, adjudication by multiple experts is not a standard practice for establishing ground truth.
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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:
- No. This is a pregnancy test, not an AI/ML device where human readers interact with AI assistance. Therefore, an MRMC study with AI assistance is not applicable and was not performed. The "reader" is the individual visually interpreting the color bands on the test strip.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The Excel OneStep Urine/Serum hCG Module Pregnancy Test is a standalone device. Its "performance" is the direct visual output (color band) based on the presence or absence of hCG. There is no separate "algorithm" in the modern AI/ML sense; the chemistry and physics of the immunoassay are the "algorithm." The human simply reads the direct result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This is not explicitly stated in the provided summary. However, for an hCG pregnancy test, the ground truth would typically be established using:
- A quantitative reference laboratory assay: A highly accurate quantitative method (e.g., ELISA, chemiluminescent immunoassay) performed on the same urine/serum samples to determine the actual hCG concentration.
- Clinical correlation: (Less likely to be the primary ground truth for in vitro diagnostic performance, but might be used to confirm clinical utility).
- This is not explicitly stated in the provided summary. However, for an hCG pregnancy test, the ground truth would typically be established using:
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The sample size for the training set:
- This information is not provided. For a traditional immunoassay, there isn't a "training set" in the machine learning sense. The device is developed and optimized through chemical and engineering principles.
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How the ground truth for the training set was established:
- This information is not provided, as the concept of a "training set" and its associated ground truth establishment process is not applicable to a traditional immunoassay in the same way it is for an AI/ML device. Device development would involve optimization against known concentrations of hCG, but this isn't structured as a machine learning training phase.
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Summary of Safety and Effectiveness
MAY - 2 1996
Excel OneStep Urine/Serum hCG Module Pregnancy Test
Excel OneStep Urine/Serum hCG Module Pregnancy Test is Excel Scientific, Inc.'s name for the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum. The exact differences between the Excel OneStep Urine/Serum hCG Module Pregnancy Test and the Syntron immunoassay, an assay for human chorionic gonadotropin currently being marketed are as follows :
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- The Syntron Quikpac I EIA protocol is a classical sandwich enzyme immunoassay where endogenous hormone hCG, is first bound by antibody covalently linked to a solid membrane. A second enzyme linked antibody is then reacted to the membrane to form antibody-enzyme complexes. The complex is reacted with a suitable substance to produce a visible "+" positive when the hCG concentration is greater than 25 miU/mL; and "-" negative on the center of the membrane indicates the absence of detectable levels of hCG.
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- The Excel OneStep Urine/Serum hCG Module Pregnancy Test is a sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay. As the specimen flows through the absorbent device via capillary action, the labeled antibody dye conjugate binds to the hCG in the specimen forming an antibodyantigen complex. This complex binds to the anti-hCG antibody immobilized on the membrane in the positive reaction zone and produces a pink-rose color band when the hCG concentration in the specimen is equal to or greater than 25 mIUmL. In the absence of hCG, no colored line will appear in the positive reaction zone. The reaction mixture continues to flow through the absorbent device past the positive reaction zone and produce a pink-rose color band in the control zone, demonstrating that the reagent and device are functioning correctly.
| Syntron Quikpac EIA | Excel OneStep Urine/Serum hCG Module | |
|---|---|---|
| Specimen Volume | 5 drops urine3 drops serum | 4 drops urine4 drops serum |
| Reagent | 2 bottles for either urine or serum | No reagent for urine or serum |
| Incubation | 3 minutes with antibody and 3 minuteswith substrate | No pre-incubation with urine or serum |
| Steps | three | one |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
The exact reagent addition differences between the above two test protocols are as follows:
§ 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.