(239 days)
The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
Here's a breakdown of the acceptance criteria and study information for the AUTION CHECK Plus device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | For each of the three operators and three Arkray urinalysis analyzers, the mean of four test results must fall within the "specification range for the lot." | Confirmed by laboratory analysis prior to release. "The means from all three operators and analyzers must fall within the specification range for the lot to be released." |
| Open Vial Stability | 30 days at 2 to 8°C | Established through accelerated stability studies. |
| Closed Vial Stability | 18 months at 2 to 8°C | Established through accelerated stability studies. |
| Shelf Life Stability | 18 months at 2 to 8°C | Established through accelerated stability studies. |
| Human Source Material Screening | Urine donors screened for HBs antigen, HCV, HIV1, and HIV2, and found to be negative by US FDA accepted methods. | "human source material used to manufacture this control was tested by FDA accepted methods" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For value assignment, the testing involves three operators and three analyzers, with each performing four tests on the control product. This means 3 operators * 3 analyzers * 4 tests = 36 individual tests per lot for value assignment.
- Data Provenance: The data is prospective, generated by Quantimetrix Corporation's Quality Control group in their laboratories. The document doesn't specify the country of origin, but given the FDA submission, it's presumably US-based.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three different operators were used for the value assignment process.
- Qualifications of Experts: The document does not explicitly state the qualifications of the operators beyond them being "operators" in the Quality Control group.
4. Adjudication Method for the Test Set
- Adjudication Method: The value assignment process uses a consensus approach where "The means from all three operators and analyzers must fall within the specification range for the lot to be released." This implies a form of consensus-based adjudication, where all operators/analyzers must agree within a specified range for the lot to be accepted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic device intended for human interpretation or a device designed to assist human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device is a quality control material; therefore, the concept of an "algorithm" or "human-in-the-loop" performance doesn't directly apply in the same way it would for an AI diagnostic tool. The performance evaluation is based on the chemical properties and stability of the control material, and its ability to produce expected results on Arkray analyzing equipment. The "standalone" performance here refers to the intrinsic characteristics of the control material.
7. Type of Ground Truth Used
- For the value assignment (which serves as the "ground truth" for the control material's expected performance), the ground truth is established by internal laboratory analysis, comparing the control material's results against a pre-defined "specification range for the lot." This effectively establishes a known, expected range for the control.
- For the stability studies, the "ground truth" is the performance of the device over time compared to its initial established values, under various storage conditions.
8. Sample Size for the Training Set
- This product is a quality control material, not an AI or machine learning model that requires a "training set." Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
- Since there is no training set for this device, this question is 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.