(57 days)
The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy.
UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home.
It is indicated for use in the early detection of pregnancy.
The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test.
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.
Here's an analysis of the provided text regarding the UniMark® Home Pregnancy Test Device, structured to address your specific questions:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Detect hCG concentrations of 25 mIU/ml or greater. | UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater. |
| Accuracy (Consumer Use) | 100% correlation with professional test in spiked samples. | 100% correlation between the UniMark® home user and the UniMark® professional test results in a consumer study. |
| Specificity | No false positives with related hormones (hLH, hFSH, hTSH). | Negative results obtained with 200 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 uIU/ml hTSH. |
| Interference | No interference from common substances at specified concentrations. | No interference from Acetaminophen (20 mg/dl), Acetylsalicylic Acid (20 mg/dl), Ascorbic Acid (20 mg/dl), Atropine (20 mg/dl), Caffeine (20 mg/dl), Gentisic Acid (20 mg/dl), Glucose (2000 mg/dl), Hemoglobin (1 mg/dl), Protein (2000 mg/dl), and pH (5 to 9). |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical (Accuracy): 364 urine specimens (189 positive, 175 negative).
- Provenance: Not explicitly stated, but likely laboratory-based. Retrospective.
- Consumer Study: 100 home users, and for each user, 4 spiked urine fractions (0, 20, 30, 1000 mIU/ml hCG) were tested. This means 400 total individual tests performed by home users.
- Provenance: Central New Jersey and New York City, prospective (performed by home users in a test setting).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical (Accuracy): The ground truth was established by a "commercially available quantitative visual hCG test." The number and qualifications of experts using this test are not specified, but it's implied to be a standard laboratory method.
- Consumer Study: The "organizer or lab assistant" observed and verified user test results. The "lab technician of Biotech Atlantic" subsequently tested the coded controls with the professional (predicate) test. The number and specific qualifications of these individuals are not provided beyond their roles.
4. Adjudication Method for the Test Set
- Non-Clinical (Accuracy): No explicit adjudication method is mentioned beyond the comparison to a "commercially available quantitative visual hCG test."
- Consumer Study: For the home user tests, the "user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative." For the internal verification, "the lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test." This implies a form of expert verification against a reference method, but not a multi-reader consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described for this device. The consumer study involved multiple users, but it was to assess user interpretation against a control, not to compare human readers with and without AI assistance or to quantify an effect size of AI improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, the non-clinical tests (Sensitivity, Accuracy, Specificity, Interference) represent standalone performance of the device without human interpretation (other than the initial reading in a lab setting). The "Accuracy" study compared the UniMark® hCG test (likely read by lab personnel) with another quantitative visual hCG test.
7. The Type of Ground Truth Used
- Non-Clinical (Sensitivity, Accuracy, Specificity, Interference): The ground truth was established against known concentrations of hCG (for sensitivity and spiked samples for accuracy) and other hormones/substances (for specificity and interference). For accuracy, a "commercially available quantitative visual hCG test" served as the reference standard.
- Consumer Study: The ground truth was established by a lab technician using the professional (predicate) UniMark® hCG Pregnancy Test Device on spiked urine samples (0, 20, 30, and 1000 mIU/ml hCG).
8. The Sample Size for the Training Set
The document does not explicitly describe a training set or a machine learning algorithm for this device. This is a chemical immunoassay, not an AI/ML-based device. Therefore, the concept of a "training set" in the context of AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no mention of a training set as this is not an AI/ML 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.