(75 days)
BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.
BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc.
The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the BeSure OneStep Ovulation Prediction test.
Here's a breakdown of the acceptance criteria and study detailed in the provided text for the BeSure Plus OneStep Ovulation Prediction test:
1. Acceptance Criteria and Reported Device Performance
The provided document defines the acceptance criterion implicitly through the performance of the predicate device and the comparison to a quantitative lab assay. The device is considered acceptable if its performance correlates highly with a commercially available one-step ovulation test and accurately identifies an LH surge at or above 30 mIU/ml, aligning with a quantitative LH EIA test.
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance and Evidence |
|---|---|---|
| Correlation with Predicate Device | To demonstrate substantial equivalence to an existing commercially available one-step ovulation test kit (BeSure OneStep Ovulation Predictor Test - K951538). This implies the BeSure Plus OneStep should have comparable accuracy and reliability in detecting LH surges. | "Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test showed a 99% correlation with results independently obtained by laboratory technicians using other commercially available onestep ovulation test." The "other commercially available onestep ovulation test" is implicitly the predicate device, K951538, given the context. |
| Accuracy of LH Surge Detection (Cutoff) | The device should accurately detect an LH surge when the LH concentration in urine is equal to or greater than 30 mIU/ml, and should not show a surge when the concentration is less than 30 mIU/ml. This is based on the established surge cutoff of ≥ 30 mIU/ml for the predicate device and the standard for ovulation prediction. | "The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). The data obtained from the LH EIA test (Syntron) indicated that LH concentration equal or greater than 30 mIU/ml exhibits LH concentration less than 30 mIU/ml exhibits no surge in BeSure Plus OneStep ovulation test..." This directly confirms the device's adherence to the 30 mIU/ml cutoff. |
| User Performance | Non-technical users (consumers) should be able to accurately use the device to detect the onset of the LH surge with precision comparable to that achieved by trained laboratory technicians using a reference immunoassay. | "These results show that nontechnical users of BeSure Plus OneStep home Ovulation Predictor Kits are able to detect the onset of the LH surge with precision comparable to that obtained by a reference immunoassay performed by trained laboratory technicians." This statement directly addresses the user performance aspect based on the 99% correlation obtained by consumers and confirmed by lab assays. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 consumers (patient urine samples).
- Data Provenance: The text does not explicitly state the country of origin. However, the manufacturer, Syntron Bioresearch, Inc., is based in Carlsbad, CA, USA, suggesting the data is likely from the United States. The study appears to be prospective in nature, as it involved "100 consumers using BeSure Plus OneStep Ovulation home test" and their urine being subsequently assayed by laboratory technicians.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The term "experts" isn't explicitly used for establishing ground truth from the perspective of interpreting results as an expert would for, say, an image. Instead, the ground truth was established by laboratory technicians using a quantitative reference method.
- Number of Experts/Technicians: Not specified as a quantity, but referred to in plural as "laboratory technicians."
- Qualifications: "trained laboratory technicians." While the specific years of experience or certifications are not provided, the "trained" designation implies they possess the necessary skills and knowledge to accurately perform and interpret the Syntron's Quantitative LH EIA test (K871602/A).
4. Adjudication Method for the Test Set
The adjudication method was essentially a comparison and confirmation process:
- Initial user interpretation: 100 consumers used the BeSure Plus one-step test.
- Independent commercial test interpretation: Laboratory technicians independently obtained results using "other commercially available onestep ovulation test" (implied to be the predicate device, K951538).
- Quantitative confirmation (Ground Truth): Laboratory technicians then assayed the same patient's urine using Syntron's Quantitative LH EIA test (K871602/A) to determine the exact LH concentration. This quantitative assay served as the definitive ground truth for LH levels.
There's no explicit mention of an "X+Y" adjudication method, as the ground truth was derived from a quantitative chemical assay rather than subjective expert interpretation (e.g., of an image). The quantitative EIA test served as the objective measure against which both the consumer results and the independent commercial test results were compared.
Crucially, it notes: "In this study, the laboratory technicians did not know the outcome of the consumer's test results," indicating blinding was employed during the quantitative confirmation to prevent bias.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This study involves a direct comparison of a new OTC device against a predicate device and a quantitative lab assay, focusing on the device's ability to detect an LH surge. The "AI" aspect is not applicable here as it's a simple, qualitative in-vitro diagnostic test.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm/device only without human-in-the-loop performance initially dictating the result interpretation.
The 99% correlation observed between the consumers' use of the BeSure Plus OneStep and the results obtained by lab technicians using another commercial test, followed by confirmation with a quantitative LH EIA test, demonstrates the standalone performance of the BeSure Plus OneStep device in detecting LH surges. The device's ability to produce a rose-pink band at ≥30 mIU/ml LH and no band at
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.