(49 days)
The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use
The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.
The Inverness Medical Innovations, Inc. Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is a quality control material intended for verifying the accuracy of the ACB Test on specific Roche clinical analyzers (INTEGRA 700/800, Roche/Hitachi 917, and Roche MODULAR P). The provided documentation describes its intended use and a general statement about its performance, but lacks specific details on the acceptance criteria and the comprehensive study design, results, and ground truth establishment typically associated with a detailed device validation study.
Here's an attempt to extract and infer information based on the provided text, while also highlighting what is not explicitly stated in the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| AVS performs within manufacturer's specifications for verifying the accuracy of the ACB Test on specified clinical analyzers. (Specific numerical criteria are not provided.) | "Results showed that AVS performs within specifications." This suggests the AVS successfully demonstrated its ability to verify the accuracy of the ACB Test when run on the Roche Integra 700/800, Roche/Hitachi 917, and Roche Modular P. |
Missing Information: The specific numerical acceptance criteria (e.g., target ranges, allowable percentage deviation from assigned values, precision requirements) are not detailed in the provided text. The statement "using revised acceptance criteria" further implies that such criteria exist but are not disclosed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The Assay Verification Set consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples." This represents the test set (the verification set itself).
- Data Provenance: The testing was conducted "internally and at multiple clinical sites." The country of origin for the data is not specified. The study appears to be prospective in nature, as it's described as an evaluation for range setting values and performance verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not explicitly stated. The document mentions the samples have "assigned IMA values over the physiological range." The method and number of experts/assigners for these values are not detailed.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Not explicitly stated. The document refers to "assigned IMA values," implying that a definitive value exists for each sample. How these values were agreed upon if multiple assessments were involved (e.g., 2+1, 3+1 consensus) is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was NOT done. This device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation. The study focuses on the device's ability to verify the accuracy of an assay on an analyzer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively a "standalone" evaluation of the AVS was done. The study evaluated how the AVS performed on various clinical analyzers to verify the accuracy of the ACB Test. This is an assessment of the AVS's performance as a material without direct human interaction interpreted for diagnostic purposes. It's about the material's consistency and its ability to challenge the analytical system.
7. The Type of Ground Truth Used
- The ground truth for the AVS samples is the "assigned IMA values." These are likely reference values established through a highly accurate and precise analytical method, often using calibrated reference materials or methods with known traceability. This would be a form of expert consensus/reference method data for the chemical properties of the control material.
8. The Sample Size for the Training Set
- Not applicable. This device is a quality control material, not a machine learning model or algorithm that requires a "training set" in the conventional sense. The "test set" described (the 20 vials) serves as the entirety of the AVS product itself that is being validated.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device. The "assigned IMA values" for the AVS samples (which serve as the ground truth for performance verification) would have been established through a rigorous process of analytical measurement, often involving multiple runs on a reference instrument and statistical analysis, possibly with certified reference materials. The exact method is not detailed.
§ 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.