(26 days)
ESA Biosciences LeadCare II Control is intended to be used to monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of lead provided by the controls allow performance monitoring within the clinically important range. For In Vitro Diagnostic Use
The ESA LeadCare II Control is customized for use on the ESA Biosciences LeadCare II Lead Analyzer and are used to verify the performance of the LeadCare II analyzers and sensors for the measurement of lead. The control solution is an aqueous solution containing bovine albumin, lead, buffers, preservative and dye in concentrations determined optimal for the LeadCare II system. The product is provided in two distinct levels, in screw capped, glass vials, each containing 2 mL of solution. One set of controls will be packaged with each LeadCare II test kit for use in quality control testing of the sensors, and verification of system performance. LeadCare II Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle. LeadCare II Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
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Acceptance Criteria and Study Details for LeadCare II Lead Controls
The provided document describes the LeadCare II Lead Controls, a quality control material intended to monitor the precision and verify the performance of the ESA Biosciences LeadCare II System for measuring lead in blood. The nature of this device (a quality control material) means that its "performance" is primarily defined by its stability, accuracy in its stated lead concentration, and its ability to provide consistent results when used with the LeadCare II analyzer. The acceptance criteria are implicitly tied to maintaining the stated levels and stability.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a quality control material, the "performance" is related to its characteristics and stability rather than diagnostic accuracy metrics like sensitivity or specificity. The document doesn't explicitly state numerical acceptance criteria values for each test, but describes the tests performed to verify specific performance requirements.
| Acceptance Criteria Category | Reported Device Performance (as described by tests conducted) |
|---|---|
| Preservation Efficacy | Tests were conducted to verify preservative efficacy. (No specific results or numerical acceptance criteria provided in this summary.) |
| Closed Bottle Stability | Tests were conducted to verify closed bottle stability. (No specific results or numerical acceptance criteria provided in this summary.) |
| Stability After Opening | Tests were conducted to verify stability after opening. (No specific results or numerical acceptance criteria provided in this summary.) |
| Comparison to Predicate Device | Substantially equivalent in function, safety, and efficacy to the Kaulson Laboratories Heavy Metal Control. |
| Test Precision and Range | Tests were conducted to verify test precision and range. (No specific results or numerical acceptance criteria provided in this summary.) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for the non-clinical tests (preservative efficacy, stability studies, precision, and range).
- Data Provenance: The studies were conducted by Bionostics, Inc., located in Devens, MA, USA. The data would therefore be of U.S. origin. The studies are non-clinical tests, likely conducted prospectively as part of product development and validation for the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
Not applicable. The ground truth for a quality control material relates to its manufactured concentration and stability, which are determined through analytical chemistry and stability studies, not by expert consensus on diagnostic images or patient data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for a quality control material is established through lab-based analytical methods rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a quality control material, not an AI or diagnostic imaging device that would involve human readers interpreting cases. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a consumable quality control material (an aqueous solution), not a software algorithm or AI-powered device. Its "performance" is inherent in its chemical composition and stability characteristics rather than an algorithmic output.
7. Type of Ground Truth Used
The ground truth for this device (LeadCare II Lead Controls) is established through analytical testing and laboratory characterization of the manufactured control solutions. This includes:
- Certified lead reference materials: Used to accurately determine the lead concentration in the control solutions.
- Stability studies: Monitoring the lead concentration and integrity of the control solutions over time under various conditions to establish shelf-life and in-use stability.
- Precision studies: Performed using established laboratory methods on the LeadCare II System itself to demonstrate repeatable results.
8. Sample Size for the Training Set
Not applicable. This device is not a machine learning or AI algorithm, so there is no "training set" in the context of an algorithm learning from data. The product is manufactured and validated based on its chemical properties and performance with the associated analytical system.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The ground truth for a quality control material is established through the manufacturing process specifications and subsequent analytical validation, as detailed in point 7.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.