(37 days)
The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy.
The CARDS® Q.S.® hCG-Urine (also sold under the brand name Concise® Performance Plus™ hCG-Urine) is a one-step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine and for the early detection of pregnancy. The test is intended for use by health care professionals.
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pinkto-purple Test Line intersecting the pre-printed horizontal blue line will also appear. The result is read at three minutes after sample application. If no blue procedural Control Line develops, the result is considered invalid.
The provided text describes the CARDS® Q.S.® hCG-Urine (and Concise® Performance Plus™ hCG-Urine) device, its intended use, and various studies performed to demonstrate its safety and effectiveness. However, it does not explicitly state formal acceptance criteria with specific numerical thresholds (e.g., sensitivity, specificity values) in a table format, nor does it present a detailed study rigorously "proving" these criteria were met with reported actual performance values in such a table.
Instead, the documentation broadly discusses studies that support the device's substantial equivalence to other FDA-cleared devices and its suitability for use.
Based on the provided text, here's an attempt to structure the information according to your requested format, while highlighting what is not explicitly stated in the document:
Acceptance Criteria and Device Performance
The provided summary does not explicitly list predefined quantitative acceptance criteria in a table format with corresponding reported performance values. It discusses various studies that demonstrated the device's performance characteristics and substantial equivalence.
Reported Performance Claims (from the "Safety and Effectiveness" section):
| Performance Aspect | Reported Outcome |
|---|---|
| Accuracy (compared to other FDA-cleared qualitative hCG devices) | Exceeding 99% |
| Intra-assay precision | Excellent |
| Inter-assay precision | Excellent |
| Lot-to-lot consistency | Reproducibly manufacturable |
| Interference with common substances | Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance. |
| Physician's Office Laboratory (POL) Accuracy | Results from three distinct sites in the United States agreed greater than 99% with expected results. |
Detailed Study Information:
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document mentions "urine samples obtained from women presenting for pregnancy testing" and "Physician's Office Laboratory studies... at three geographically distinct sites in the United States." No specific number of samples or participants is provided.
- Data Provenance: United States (for POL studies, and implied for the comparison study as it's for FDA clearance). The data appears to be prospective in nature, as samples were "obtained from women presenting for pregnancy testing."
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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):
- Not explicitly stated. The document refers to "expected results" for ground truth, but does not detail how this ground truth was established (e.g., by experts, reference laboratory tests, or clinical outcomes). For POL studies, it states "doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly," implying that their results were compared against an 'expected result' reference.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated. Given the nature of a rapid immunoassay, it's unlikely that a complex adjudication method like 2+1 or 3+1 would be applicable for determining the ground truth of hCG presence in urine samples. The "expected results" likely refer to results from a recognized reference method or device.
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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, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of radiology or pathology images. The "Physician's Office Laboratory studies" served a similar purpose of demonstrating usability by diverse personnel, but it's not an MRMC study in the typical sense of AI comparison. The studies showed that "doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone immunoassay; its "performance" is its ability to detect hCG in a sample. The "Accuracy exceeding 99%" study refers to the device's intrinsic performance against other established qualitative hCG detection devices. The Physician's Office Laboratory studies evaluate usability and reproducibility rather than standalone algorithmic performance in the modern AI sense.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. For the "Accuracy exceeding 99%" study, the ground truth likely came from a comparison to "other FDA-cleared devices for qualitative hCG detection," meaning the results of these established devices served as the reference standard. For the POL studies, it was against "expected results," which would similarly be derived from a reference method. It's improbable that pathology or long-term outcomes data would be used as ground truth for a qualitative hCG urine test.
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The sample size for the training set:
- This concept is not applicable as the device is a chemical immunoassay, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is inherent in its biochemical design and manufacturing consistency.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.
§ 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.