Search Results
Found 1 results
510(k) Data Aggregation
(39 days)
The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by applying urine sample through urination, or dipping test device into collected urine sample, and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane. A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". The ACON Quik-Check II Midstream Home Pregnancy Test qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no crossreactivity.
Acceptance Criteria and Device Performance Study for ACON Quik-Check II Midstream Home Pregnancy Test
The provided documentation describes the ACON Quik-Check II Midstream Home Pregnancy Test, a qualitative test designed for over-the-counter use to detect elevated levels of human Chorionic Gonadotropin (hCG) in urine. The primary study presented aims to establish substantial equivalence to a predicate device, the ACON Midstream Home Pregnancy Test (K983090).
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages or thresholds for sensitivity, specificity, or accuracy. Instead, the reported performance focuses on comparative accuracy to a predicate device. The general implicit acceptance criterion for a device intended for over-the-counter use is high accuracy and ease of use for the target consumer.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| High correlation/accuracy with predicate device | Over 99% correlation between ACON Quik-Check II Midstream Home Pregnancy Test and the current ACON Midstream Pregnancy Test (K983090) in two studies (consumer field study and retrospective focus group study). |
| Qualitative detection of hCG at 25 mIU/ml cutoff | The device "qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml." This is a design specification rather than an acceptance criterion from a study, but it is a key functional requirement. |
| Absence of cross-reactivity with related hormones | "The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity." This demonstrates specificity. |
| User comprehension and ease of use | "The results also showed that the vast majority of the participants found ACON Quik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results." This is an important criterion for an OTC device. |
| Robustness under various conditions (specificity, interference, etc.) | Additional laboratory study results on performance include specificity, interference substances, urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions. (Specific data not provided in this summary). |
2. Sample Sizes and Data Provenance
- Test Sets:
- Consumer Field Study: 113 female participants.
- Retrospective Focus Group Study: 35 female participants.
- Data Provenance: The document does not explicitly state the country of origin for the data. The studies are described as "clinical studies" and "laboratory studies," implying they were conducted in a controlled environment, likely in the US where the device is intended for market. The "consumer field study" and "retrospective focus group study" suggest real-world or simulated real-world usage by consumers. Both studies are described as retrospective in terms of comparing results to an existing device.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. Given the nature of a home pregnancy test comparing to a predicate, the "ground truth" for the test sets would likely be the results from the predicate device itself, which is implicitly considered accurate for the purpose of demonstrating equivalence.
4. Adjudication Method
The document does not specify an adjudication method (such as 2+1 or 3+1). Since the studies focus on correlation between two devices, it's implied that the results from the predicate device serve as the primary comparison point. There is no mention of independent interpretation or resolution of discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is a standalone diagnostic test, not an AI-assisted diagnostic tool for interpretation by humans.
6. Standalone Performance Study
A standalone performance study was implicitly done in the context of comparing the new device against the predicate device. The device's performance is reported in terms of its correlation with the predicate. The "additional laboratory study results" on specificity, interference, pH, specific gravity, and hook effect also represent standalone evaluations of the device's inherent characteristics.
7. Type of Ground Truth Used
The ground truth used for the reported clinical studies was primarily the results obtained from the predicate device, the ACON Midstream Home Pregnancy Test (K983090). This indicates that the assessment of the new device's accuracy relied on its agreement with an already legally marketed and presumed accurate test.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This is typical for simple diagnostic assays like pregnancy tests, which are usually developed based on known biochemical principles and then validated through clinical and analytical studies, rather than "trained" in the machine learning sense.
9. How Ground Truth for the Training Set Was Established
As there is no specific mention of a training set in the context of a machine learning algorithm, there is no information on how its ground truth was established. The development of the device likely relied on established scientific understanding of hCG detection rather than a data-driven training process. The performance characteristics like the 25 mIU/ml cutoff and cross-reactivity were likely determined through laboratory experimentation and standardization against international reference materials (e.g., World Health Organization Third International Standard).
Ask a specific question about this device
Page 1 of 1