(60 days)
The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.
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1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Sensitivity) | Reported Device Performance (Sensitivity) |
|---|---|
| Not explicitly stated in the provided text. | 25 mIU/ml hCG |
Note: The document only reported the sensitivity of the device but did not explicitly define an "acceptance criteria" against which this performance was measured within the provided text. It simply stated the device's sensitivity.
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not contain information regarding:
- The sample size used for the test set.
- The data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The provided document does not contain information regarding:
- The number of experts used to establish the ground truth for the test set.
- The qualifications of those experts.
4. Adjudication Method for the Test Set:
The provided document does not contain information regarding the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The provided document does not contain information indicating whether an MRMC comparative effectiveness study was done, nor any effect size of human reader improvement with or without AI assistance. This device is an in-vitro diagnostic test, not typically associated with AI assistance for human readers in the way an imaging AI might be.
6. Standalone (Algorithm Only) Performance Study:
The provided document describes the "Ameditech ImmuTest™ hCG Pregnancy Test" as a "visual, qualitative result" test. This strongly suggests it is a traditional in-vitro diagnostic assay read by a person, not an algorithm. Therefore, a standalone (algorithm only) performance study does not appear to be relevant or applicable to this device based on the information provided.
7. Type of Ground Truth Used:
The provided document does not explicitly state the type of ground truth used. For an hCG pregnancy test, the ground truth would typically be established by a reference method for hCG detection, or confirmed clinical pregnancy status.
8. Sample Size for the Training Set:
The provided document does not contain information regarding the sample size for the training set.
9. How Ground Truth for the Training Set Was Established:
The provided document does not contain information on how the ground truth for the training set was established.
§ 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.