(31 days)
The pH and Amines External Control Set is intended for use as external controls in accordance with the package insert instructions for the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. When following these instructions, the Controls are to be used in the same manner as a patient swab specimen. For use by healthcare professionals.
The Positive Control contains a buffered solution (pH > 4.7 and volatile amines > 0.5mM); the Negative Control contains a buffered solution (pH
The provided text describes a medical device, the "pH and Amines External Control Set", and its regulatory approval process, specifically focusing on its substantial equivalence to other marketed devices. However, the document does not present a typical study design with acceptance criteria and device performance metrics in the way one would expect for a diagnostic or therapeutic device.
Instead, the "studies" mentioned are related to the manufacturing and design of the control set to ensure it performs as intended to verify other test systems.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) for the pH and Amines External Control Set in the context of a clinical study. The criteria and performance mentioned are related to the manufacturing quality and functional equivalence of the control set itself.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similarity to other commercially available controls: In terms of features and intended use. | The pH and Amines External Control Set was shown to be similar to other commercially available controls in terms of features and intended use. |
| Inter-assay precision: The ability of the controls to produce consistent results across different assays. | Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. |
| Intra-assay precision: The ability of the controls to produce consistent results within the same assay. | Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. |
| Lot-to-lot consistency: The ability of different manufacturing lots of the controls to produce consistent results. | Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. |
2. Sample sized used for the test set and the data provenance
- Test set sample size: Not explicitly stated. The studies described appear to be more about manufacturing quality control and comparison to predicate devices, rather than a clinical test set in the traditional diagnostic sense.
- Data provenance: Not specified. The studies were undertaken by the manufacturer, Quidel Corporation. Given the nature of a 510(k) submission, these would likely be internal studies. There is no mention of country of origin for data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an external control set for other diagnostic tests, not a diagnostic device itself that produces a clinical result requiring expert interpretation for ground truth. The "ground truth" for the controls themselves is their chemical composition (pH and amine levels) and their ability to elicit expected color responses from the diagnostic tests they are designed to control.
4. Adjudication method for the test set
Not applicable. There is no mention of expert adjudication for a test set, as the studies are focused on the manufacturing and functional performance of the control set itself.
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
Not applicable. The device is a "pH and Amines External Control Set," which is a quality control material, not a diagnostic or AI-powered device. Therefore, MRMC studies and assessment of human reader improvement with or without AI assistance are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the pH and Amines External Control Set is based on its chemical composition:
- Positive Control: Buffered solution with pH > 4.7 and volatile amines > 0.5mM.
- Negative Control: Buffered solution with pH
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.