(35 days)
LiniCAL™ Protein 3 Calibration Verifiers Levels A – E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™
Not Found
The provided document is a 510(k) clearance letter from the FDA for a quality control material, not a device that relies on an algorithm or AI. Therefore, it does not contain the specific information requested about acceptance criteria, study details, expert involvement, or AI performance metrics.
However, based on the context of the document, I can infer some aspects related to "acceptance criteria" in a general sense for this type of product and the "study" that supports its clearance.
Inferred Acceptance Criteria and "Study" for LiniCAL™ Protein 3 Calibration Verifiers:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a quality control material used to verify calibration and assess linearity, the "acceptance criteria" and "reported device performance" would likely revolve around the material's ability to consistently provide expected values when tested on the target instrument (Beckman-Coulter Immage™).
| Acceptance Criteria Category | Reported Device Performance (Inferred) |
|---|---|
| Value Consistency (Intra-Lot) | Each level (A-E) demonstrates consistent analyte concentrations within established analytical limits across different vials from the same manufacturing lot. |
| Value Consistency (Inter-Lot) | Each level (A-E) demonstrates consistent analyte concentrations across different manufacturing lots, within established analytical limits. |
| Stability | The material maintains its analyte concentrations within specified limits over its claimed shelf-life and under recommended storage conditions. |
| Matrix Effects | The material's matrix does not interfere with the reliable measurement of Protein 3 on the Beckman-Coulter Immage™ system. |
| Assigned Values Accuracy | The assigned values for each level (A-E) are accurately determined and traceable to a reference method or material. |
| Linearity Verification Efficacy | When used as intended, the material helps verify the linearity of the Beckman-Coulter Immage™ system for Protein 3, allowing for detection of non-linear responses. |
| Predicate Device Equivalence | Performance characteristics (e.g., value ranges, stability) are substantially equivalent to a legally marketed predicate quality control material for Protein 3. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. For a quality control material, this would typically involve testing multiple replicates of each level across several manufacturing lots and potentially different instruments.
- Data Provenance: Not specified, but likely from internal testing conducted by CLINIQUA Corporation. Given the nature of a 510(k), it would be retrospective data collected during product development and validation. The country of origin would likely be the USA, where CLINIQUA Corporation is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For a quality control material, "ground truth" establishment would involve laboratory scientists or chemists with expertise in assay development, validation, and quality control. They would be responsible for assigning reference values to the material.
- The exact number and qualifications are not stated, but it would involve personnel trained in clinical chemistry and analytical method validation, likely with several years of experience in an IVD manufacturing environment. There wouldn't be "experts" in the same way as, say, radiologists reviewing images, but rather the internal scientific team.
4. Adjudication Method for the Test Set:
- Not applicable in the sense of expert review for diagnostic decisions. The "adjudication" would be a data review process by an internal quality assurance or R&D team against predefined acceptance criteria for analytical performance. This would be based on statistical analysis of the test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not applicable to a calibration verifier/quality control material. MRMC studies are used for diagnostic devices that involve human interpretation (e.g., imaging devices).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical reagent, not an algorithm. Its "performance" is its chemical and physical stability and its ability to provide accurate and consistent assay values.
7. The Type of Ground Truth Used:
- The ground truth would be assigned values derived from reference methods or certified reference materials (if available) for Protein 3, established through rigorous analytical testing and metrological traceability. This is akin to "verified analytical values."
8. The Sample Size for the Training Set:
- Not applicable. This device is not an algorithm that requires a "training set." It is a manufactured material.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no training set for a quality control material.
§ 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.