(53 days)
The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.
VALIDATE Cardiac Markers Calibration Verification Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.
The provided text describes a 510(k) summary for the "VALIDATE® Cardiac Markers Calibration Verification Test Set". This device is a quality control material intended to verify calibration, validate reportable ranges, and determine linearity in chemistry systems for CK-MB and Myoglobin. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested elements (acceptance criteria, study design, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of document, which is primarily a regulatory filing for an in vitro diagnostic quality control material.
However, I can provide the available information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in terms of accuracy, precision, sensitivity, or specificity. Instead, the primary "acceptance criterion" for this regulatory submission is "substantial equivalence" to predicate devices. This means that the device must perform similarly enough to a legally marketed device that it does not raise new questions of safety or effectiveness.
Reported Device Performance:
| Characteristic | VALIDATE® CM1 (Preproduction Lots) | Predicate Devices (DOCUMENT® CK-MB CAL•VER and Bio-Rad Liquichek™ Cardiac Markers Control LT) |
|---|---|---|
| Performance Claim/Demonstration | The performance of VALIDATE® CM1 Calibration Verification Test Set solutions on the Abbott AxSym instrument system as compared to DOCUMENT® CK-MB CAL•VER and Bio-Rad Liquichek Cardiac Markers Control LT has been shown to be substantially equivalent. This implies that the ranges and linearity observed with the VALIDATE® CM1 material were comparable to those observed with the predicate devices when used in the same context (calibration verification). | DOCUMENT® CK-MB CAL•VER: Intended for quantitative determination of linearity, calibration verification, verification of analytical measurement range (AMR), and clinical reportable range (CRR) of manual and automated chemistry analyzers for CK-MB. |
Bio-Rad Liquichek™ Cardiac Markers Control LT: Intended as an assayed quality control serum to monitor the precision of laboratory testing procedures for CK-MB, MYO, Digitoxin, Homocysteine, NT-ProBNP, Troponin-I, Troponin-T.
The specific performance metrics (e.g., expected linearity, accuracy ranges) of the predicate devices themselves are not explicitly detailed as acceptance criteria within this document, but their established performance serves as the benchmark for "substantial equivalence." |
Note: For in vitro diagnostic quality control materials, "performance" is often demonstrated by showing that the material behaves predictably and consistently across a range of values, allowing for the verification of an instrument's calibration and linearity. The specific numerical accuracy or precision of the new material is typically compared to that of existing, similar products rather than to a fixed clinical endpoint.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "preproduction lots of VALIDATE® CM1 Calibration Verification Test Sets". However, it does not specify the number of individual vials, batches, or replicates used in the comparative testing.
- Data Provenance: The study appears to be an internal, prospective validation performed by Maine Standards Company. There is no mention of country of origin of the data beyond the company's location in Maine, USA. The study design is not a traditional "test set" in the clinical sense, but rather a laboratory comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of this device refers to the known, assigned values of the analytes in the control material for calibration verification. These values are established through rigorous analytical testing and metrology, not by expert consensus in the way a diagnostic image might be. The document does not specify the number or qualifications of the analytical chemists or metrology experts involved in assigning these values.
4. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic device involving interpretation, there is no need for adjudication of results by human experts. The "results" are analytical measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not applicable for this type of in vitro diagnostic quality control material. MRMC studies are typically used to assess the effectiveness of diagnostic devices (e.g., imaging AI) where multiple human readers interpret cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical diagnostic control material, not an algorithm or software. It is designed to be used with human-operated laboratory equipment.
7. The Type of Ground Truth Used
The ground truth for this device is the assigned analyte concentrations within the calibration verification materials. These values are established through a robust process of analytical measurement, often traceable to reference materials and methods, rather than expert consensus, pathology, or outcomes data. The document implies these values are "lot specific analyte values" provided with the product.
8. The Sample Size for the Training Set
Not applicable. This device is a physical in vitro diagnostic control material, not an AI/ML algorithm or system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.