(259 days)
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.
The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product insert. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f.specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working properly and the operator performed the test procedure correctly.
The provided text describes a 510(k) submission for the BinaxNOW® Malaria Positive Control, a quality control material, not a diagnostic device with performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design parameters for evaluating device performance against ground truth, and human-in-the-loop studies is not applicable to this type of submission.
The "performance summary" section details the stability and shelf life of the control material, which are the relevant performance characteristics for a quality control product.
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the Quality Control Material) | Reported Device Performance |
|---|---|
| Stability (Lyophilized, closed vial): | 5 months when stored at 2-8°C. |
| Stability (Reconstituted, open vial): | 5 months when stored at -20°C. |
Note: The primary "performance" of this device is its stability and its ability to consistently produce a positive result when run with the BinaxNOW® Malaria Test, which verifies the test's proper function.
2. Sample size used for the test set and the data provenance
Not applicable. This is a quality control material, not a diagnostic device evaluated against a patient test set. The "testing" referred to in the document is internal stability testing of the control material itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for diagnostic devices (e.g., disease presence) is not relevant for a quality control material. The "ground truth" for this control is its consistent positive reactivity.
4. Adjudication method for the test set
Not applicable.
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. This is not an AI-assisted diagnostic device, nor is it a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
For the BinaxNOW® Malaria Positive Control, the "ground truth" is its designed positive reactivity. When run on the BinaxNOW® Malaria Test, the control is intended to "always generate positive results on both the P.f. specific (HRP II) test line and on the pan-malarial test line." This demonstrates that the control material is functioning as intended, and by extension, that the test reagents and operator procedure are correct.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an algorithm or diagnostic device for this quality control product.
9. How the ground truth for the training set was established
Not applicable.
§ 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.