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510(k) Data Aggregation
(31 days)
The ACON SPECTRUM hCG Midstream Pregnancy Test is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.
The test utilizes a combination of mouse monoclonal antibody conjugated with a proprietary dye-binding system and goat polyclonal antibody to qualitatively detect elevated levels of hCG in urine samples. Test may be done by applying sample and observing visually for the formation of colored lines. After sample application, specimen migrates via capillary action along the components of the test. During migration, hCG molecule in the sample reacts with the monoclonal hCG antibodies-dye conjugate, and also reacts with the polyclonal hCG antibody striped down at the test region of the membrane to form an antibody-antigen-antibody-dye complex as a colored test line. Therefore, 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, if the test has been performed properly, a GREEN colored zone in the control (C) region will always be cleared to expose a RED line, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. The presence of the green dye or absence of the red control line in the C region indicates that the test result is "invalid".
The ACON SPECTRUM hCG Midstream Pregnancy Test qualitatively detects hCG in urine sample with a designated cutoff hCG concentration of 25 mIU/mL. The cutoff concentration of this test has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). The addition of LH (300 mIUmL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIUmL hCG) and positive (25 mIU/mL hCG) urine samples showed no interference in correctly reading the expected test results.
The ACON SPECTRUM hCG Midstream Pregnancy Test is a qualitative over-the-counter pregnancy test.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACON SPECTRUM hCG Midstream Pregnancy Test are based on its ability to qualitatively detect human Chorionic Gonadotropin (hCG) in urine at a designated cutoff concentration of 25 mIU/mL. The study performed aims to demonstrate performance equivalency to a legally marketed predicate device. While specific numerical acceptance criteria (e.g., sensitivity, specificity percentages) are not explicitly stated in the provided text for the new device, the reported performance is described in comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative detection of hCG in urine at 25 mIU/mL cutoff. | Standardized to WHO Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). |
| No interference from LH, FSH, and TSH. | Addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine samples showed no interference in correctly reading expected test results. |
| Performance equivalency to the current ACON Midstream Pregnancy Test (Predicate Device K983090). | Consumer Field Study: Demonstrated performance equivalency between the new ACON SPECTRUM hCG Midstream Pregnancy Test and the current ACON Midstream Pregnancy Test. |
| Retrospective Focus Group Study: Demonstrated high degree of correlation between the new ACON SPECTRUM hCG Midstream Pregnancy Test and the current ACON Midstream Pregnancy Test in terms of reproducibility and precision. | |
| Ease of use and clear interpretability for consumers. | The vast majority of participants found the new test very easy to use, and had no trouble understanding the labeling, reading instructions, or interpreting results. |
| Robustness and accuracy under various conditions. | Additional laboratory studies (specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, sample and dip time flexibility, and urination studies) indicate the device is robust and will give accurate results under many adverse conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Consumer Field Study: "A consumer field study conducted in the U.S. by consumers with varying social-economic backgrounds." The exact sample size is not specified.
- Retrospective Focus Group Study: The exact sample size is not specified.
- Data Provenance: The consumer field study was conducted in the U.S., indicating the data is from the United States. Both the consumer field study and the retrospective focus group study are described, suggesting a mix of prospective (consumer field study) and retrospective (focus group study) data collection methods, although specifics are limited.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the consumer field or focus group studies. The primary comparison appears to be between the new device and a predicate device, as well as against the expected results based on known hCG concentrations. The "ground truth" for the non-interference studies was established by preparing urine samples with known hCG concentrations (0 mIU/mL and 25 mIU/mL) and adding known concentrations of LH, FSH, and TSH.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1, 3+1, none) for the test set results. For the consumer field study and focus group, the consumers themselves were interpreting the results, and their interpretation was correlated with the predicate device. For the laboratory studies, the expected outcome (positive/negative) was based on the prepared sample concentrations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was mentioned. This device is a visually read, over-the-counter pregnancy test, not an AI-assisted diagnostic tool for expert readers.
6. Standalone Performance Study
Yes, a standalone performance study was done implicitly and explicitly:
- The device's ability to "qualitatively detect elevated levels of hCG in urine" at a designated cutoff of 25 mIU/mL was assessed. This is a standalone performance metric.
- The non-interference studies with LH, FSH, and TSH, and the various other additional laboratory studies (specificity, urinary pH, specific gravity, dose hook effect, etc.) assess the standalone performance of the ACON SPECTRUM hCG Midstream Pregnancy Test in various controlled conditions.
7. Type of Ground Truth Used
The ground truth for the performance claims appears to be a combination of:
- Known concentrations of hCG: For establishing sensitivity at the 25 mIU/mL cutoff and for interference studies (0 mIU/mL hCG for negative, 25 mIU/mL hCG for positive). These concentrations are standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589).
- Results from a predicate device: The current ACON Midstream Pregnancy Test (K983090) served as a comparator for equivalency in the consumer field study and retrospective focus group.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical-based assay with visual interpretation, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/algorithm-based device.
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