(48 days)
QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.
QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert. This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.
This document is a 510(k) Summary for a Quality Control Material (QCM), not a diagnostic or therapeutic medical device. Therefore, the typical acceptance criteria and study designs associated with clinical performance (like sensitivity, specificity, reader studies, etc.) do not directly apply.
Instead, the "acceptance criteria" for a QCM like QuickCheck Liquid Chemistry Control are primarily related to demonstrating substantial equivalence to an existing predicate device based on its intended use, technological characteristics, and safety and effectiveness for its purpose. The study involves a comparative analysis of these characteristics.
Let's break down the information based on your request, adapting it to the context of a QCM 510(k) submission:
Description of Acceptance Criteria and Study
The acceptance criteria for the QuickCheck Liquid Chemistry Control device are based on demonstrating its substantial equivalence to the predicate device, "QUICKCHECK UNASSAYED CHEMISTRY CONTROL, Levels 1 and 2." This equivalence is established by comparing key technological characteristics and intended use. The study demonstrates that the new device is as safe and effective as the predicate for its intended purpose of monitoring the performance of routine chemistry analytes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Aspects for Substantial Equivalence) | Proposed Device: QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed) | Predicate Device: QUICKCHECK UNASSAYED CHEMISTRY CONTROL |
|---|---|---|
| Intended Use | Assayed quality control serum for monitoring performance of routine chemistry test procedures. | Unassayed quality control serum for monitoring performance of routine chemistry test procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Liquid, Frozen | Liquid, Frozen |
| Analytes | 59 analytes of clinical significance that may be found in serum. | 43 analytes of clinical significance that may be found in serum. |
| Levels | Three (3) levels | Two (2) levels |
| Preservatives | Ciprofloxacin | Ciprofloxacin |
| Storage | -20°C | -20°C |
| Stability | Until expiration date noted on vial label. | Until expiration date noted on vial label. |
| Conclusion of Equivalence | Information provided demonstrates substantial equivalence to predicate device. | (N/A – predicate for comparison) |
Interpretation of "Performance" for a QCM: For a QCM, "performance" here refers to its suitability to serve its purpose (monitoring test procedures) and its inherent characteristics being comparable or improved in a way that doesn't raise new safety or effectiveness concerns. The key "performance" demonstrated is that the device is a quality control material with appropriate characteristics, and the differences (e.g., more analytes, more levels, assayed option) are not considered to diminish safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a clinical test set. The study involves a comparative analysis of the product's specifications and characteristics against a predicate device. It's about comparing the design and composition, not analyzing a sample of clinical cases.
- Data Provenance: The data comes from the specifications and characteristics of the proposed device (QuickCheck Liquid Chemistry Control) as manufactured by Consolidated Technologies, Inc. This is a prospective submission of a new product with its defined characteristics. The predicate device's characteristics are also documented specifications. The country of origin for the data is implicitly the USA, where Consolidated Technologies is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence/absence) is not established for a QCM.
- Qualifications of Experts: Not applicable. The "ground truth" for a QCM's characteristics typically comes from internal manufacturing and quality control processes to establish its composition, stability, and target values.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" in the clinical sense requiring expert adjudication. The comparison is between documented specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation devices where human reader performance is being evaluated with and without AI assistance. A Quality Control Material does not involve human interpretation or AI assistance in this manner.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical material (control serum), not an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context refers to the defined specifications and characteristics of the Quality Control Material itself, as determined by the manufacturer through their development, manufacturing, and quality control processes. This includes the matrix, analytes present, stability, and target values or ranges (as provided to customers who request assayed product). For the purpose of substantial equivalence, the "ground truth" is that the device performs as a QCM consistent with its stated specifications and is comparable to the predicate.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. QCMs are not "trained" in the way AI algorithms are. Their "training" is analogous to the rigorous product development, formulation, and quality control that ensures consistent manufacturing and performance Lot-to-Lot.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As noted above, there isn't a "training set" in the AI sense. The establishment of "ground truth" (i.e., the reliable characteristics and performance of the QCM) is achieved through:
- Manufacturing processes: Controlled formulation and production to ensure specific concentrations of analytes.
- Analytical testing: In-house testing using validated methods to determine the actual values for analytes present (especially for assayed controls), stability studies, and assessment of physical properties.
- Compliance with quality systems: Adherence to Good Manufacturing Practices (GMP) and ISO standards that govern the production and testing of in vitro diagnostic products to ensure consistency and reliability.
§ 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.