(59 days)
EZ Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.
EZ Sure OneStep Pregnancy Test is a sandwich solid phase dyeconjugated non-enzyme immunoassay. When the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band in the control zone, demonstrating that the reagents and the device are functioning correctly.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | High agreement with predicate device (BeSure OneStep) and ability to correctly identify hCG = 25 mIU/mL as positive. | 100% agreement with predicate device (90 positive, 70 negative). |
| Identifies 0 & 20 mIU/mL as negative. | ||
| Identifies 25, 100, 450,000 mIU/mL as positive. | ||
| Sensitivity | Detect hCG at 25 mIU/mL or greater. | Can detect hCG at 25 mIU/mL or greater. |
| Specificity | No false positives from menopausal urine or common interfering substances. | 20 postmenopausal urine samples tested negative. |
| No interference from 12 common substances (e.g., Acetaminophen, Glucose, Hemoglobin, Hormones like hTSH, hLH, hFSH) at specified concentrations. | ||
| Precision (Intra-Assay/Within Run) | Consistent and correct identification of negative and positive samples within a single run. | 100% correct identification of negative (0 mIU/mL) and positive (25, 100, 450,000 mIU/mL) values in 11 replicates. |
| Precision (Inter-Assay/Between Run) | Consistent and correct identification of negative and positive samples across multiple runs and different lots. | 100% correct identification of negative (0 mIU/mL) and positive (25, 100, 450,000 mIU/mL) values in 11 independent assays using 3 different lots over a two-month period. |
2. Sample Size Used for the Test Set and Data Provenance
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Accuracy Study:
- Sample Size: A total of 100 positive urine specimens. The table shows 90 positive and 70 negative results, implying a total of 160 specimens were included in the comparison with the predicate device.
- Data Provenance: Not explicitly stated, but the context of the K962580 premarket notification suggests it's likely a retrospective study conducted by the manufacturer, Excel Scientific, Inc., or a contract lab. There is no information on the country of origin of the data.
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Sensitivity (Known amounts of hCG added to urine pool): Test was done on one urine pool spiked with various concentrations of hCG.
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Specificity (Menopausal Urines):
- Sample Size: 20 urine specimens from postmenopausal women.
- Data Provenance: Not explicitly stated, but likely a retrospective study.
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Specificity (Interfering Substances): Test was done on urine samples (0 and 25 mIU/mL hCG) spiked with specified substances.
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Precision Studies:
- Sample Size: 11 replicates for intra-assay precision, and 11 independent assays with 3 different lots for inter-assay precision. Four specimens (0, 25, 100, 450,000 mIU/mL hCG) were used for each.
- Data Provenance: Not explicitly stated, likely an internal study by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish the ground truth for this device. The ground truth appears to be established by:
- Comparison to a predicate device (Syntron's BeSure OneStep hCG Test) for the accuracy study.
- Spiking urine with known concentrations of hCG for sensitivity and some specificity testing.
- The known status of urine samples (e.g., "postmenopausal women" for specificity).
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The comparisons appear to be direct, without a separate review or consensus process for the test results.
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
No MRMC study was done, nor is this an AI-driven device. This is an in-vitro diagnostic test kit.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is a standalone in-vitro diagnostic test kit that produces a visual result (color band). The "standalone" performance is the core of the studies described. It's not an algorithm, but a chemical immunoassay.
7. The Type of Ground Truth Used
The ground truth used in these studies includes:
- Reference Device Comparison: Syntron's BeSure OneStep hCG Test for accuracy.
- Known Concentrations: hCG spiked into urine pools at specific mIU/mL values for sensitivity.
- Biological State: Urine from "postmenopausal women" to assess specificity against other hormones.
- Spiked Interfering Substances: Urine samples with known concentrations of potential interfering substances to assess specificity.
8. The Sample Size for the Training Set
There is no mention of a training set as this is not a machine learning or AI-based device. The device's "training" in a general sense would be the research and development phase where the assay components are optimized, but specifics of data used for that are not provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly defined "training set" in the context of an immunoassay like there would be for a machine learning model. The development of the assay would involve laboratory optimization to achieve the desired performance characteristics (sensitivity, specificity) against known standards and samples.
§ 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.