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For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions: Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226), Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226), Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236). These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Qualicheck 5+ Level 1, S7730 (K980135), Qualicheck 5+ Level 2, S7740 (K980135), Qualicheck 5+ Level 3, S7750 (K980135), Qualicheck 5+ Level 4, S7760 (K980135). These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), Qualicheck 5+, Level 3, S7750, (K980135). These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), High Metabolite QUALICHECK Level 1, S7570 (K130415). These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative.

VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: AutoCheck6+ Level 1, S7835 (K051928), AutoCheck6+ Level 2, S7845 (K051928), AutoCheck6+ Level 3, S7855 (K051928), Cleaning Met II Solution, S8377 (K051968). These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution. The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.

The provided document describes the clearance of several "Verification Kits" as calibration verification materials for in vitro diagnostic use. It establishes substantial equivalence by comparing the new kits to a predicate device (Validate GC1, GC2, GC3, and GC4 Calibration Verification/Linearity Test Sets).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance of the new Verification Kits. Instead, it leverages the previous 510(k) clearances of the individual components within these kits and argues that because the new kits are essentially repackaged and relabeled versions of already cleared products, their performance characteristics are maintained. The acceptance criteria essentially revolve around demonstrating that the new kits are substantially equivalent to the predicate device and that their performance (stability, storage, traceability, and value assignment) is consistent with the cleared individual components.

• Intended Use
• Fundamental Scientific Technology
• Features
• Characteristics | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Intended Use: "For in vitro diagnostic use. ... assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges." (Similar to predicate)
• Fundamental Scientific Technology: All kits are liquid, aqueous solutions, similar to predicate.
• Features: All kits are multi-analyte controls.
• Characteristics: Product Code (JJY), Matrix (Aqueous primarily, predicate has human serum and aqueous), Traceability (IUPAC pH scale, NIST SRM, IFCC, SIGMA, primary analytical standards). Measurands vary but are within the scope of multi-analyte controls. |
  | Stability (Shelf Life):
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Shelf life: 24 months (or 12 months for VK-Crea) as maximum, depending on oldest component. (Predicate: 12 months for all). Document states stability is "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968" (previous clearances of individual components). |
  | Stability (Open Vial):
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Open vial stability: N/A, "shall be used immediately." (Predicate: 12 months). The document states that the open vial stability for the new kits is "not affected by the repackaging" implying that the lack of open vial stability is part of the established performance. |
  | Storage Conditions:
• Maintained from individual components | VK-3, VK-R5, VK-R7, VK-Crea: 2 °C – 8 °C.
  VK-4: 2 °C – 25 °C. (Predicate: 2 °C – 8 °C). Document states storage conditions are "for the most temperature sensitive component" and "documented by reference to K150226, K980135, K130415, K051928 and K051968". |
  | Traceability:
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• Traceable to "established international references as defined for the individual components and are unchanged." (Predicate: NIST SRM, primary analytical standards). Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |
  | Value Assignment:
• Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
• "Assigned values for each of the parameters are transferred unchanged from the labeling of the individual components to the Verification Kits." Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional "test set" in the context of device performance in the same way one would for a new clinical diagnostic algorithm. This submission is for an in vitro diagnostic control material that is a repackaging of existing, cleared components.

• Sample Size for Test Set: Not applicable in the conventional sense. The "test" for the new kits primarily involves demonstrating that repackaging does not alter the established performance of the individual components. The performance data for the individual components would have been provided in their respective 510(k) submissions (K150226, K130236, K980135, K130415, K051928, K051968). The current submission relies on references to these previous clearances.
• Data Provenance: The data provenance for the underlying performance of the individual components would be detailed in their original 510(k) submissions. This document implies retrospective reliance on previously cleared data. It does not mention any new prospective studies specific to the repackaged kits, beyond demonstrating that the new packaging/labeling process itself doesn't degrade the product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The "ground truth" for calibration verification kits refers to the accurately assigned values for the analytes. This is established through rigorous analytical measurement and traceability to international standards (e.g., NIST SRM, IUPAC pH scale, IFCC, SIGMA), not by expert consensus in clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable for a calibration verification kit. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human experts are interpreting results and discrepancies need to be resolved. The "truth" for these kits is analytical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used for evaluating the performance of imaging or other diagnostic devices where human interpretation is involved, often in comparison to an AI algorithm. The devices in question are calibration verification kits, which are chemical analytical controls. There is no human "reader" or AI involved in their direct function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The devices are physical chemical control solutions, not software algorithms.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these calibration verification kits is analytical traceability, established through:

• Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM).
• International Standards: Traceability to IUPAC pH scale, IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) standards, and SIGMA standards.
• Primary Analytical Standards: The document mentions "primary analytical standards" for the predicate device, implying similar methodologies for the SE device's components.

These methods involve precise chemical and physical measurements to assign accurate values to the analytes in the control solutions.

8. The Sample Size for the Training Set

This is not applicable. These are physical chemical control materials, not AI algorithms or models that require training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set." The ground truth for the performance parameters of the individual components of these kits was established through analytical methods and traceability as described in point 7, during their original 510(k) clearances.

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