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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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The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cC22+, cClu, cLac, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters p02 and for In vitro testing of pleura samples for the pH parameter.

pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.

pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.

pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.

Potassium (cK+): the measurements of the concentration of plasma are used to monitor the electrolyte balance.

Sodium (cNa+); the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.

Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.

Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.

Glucose (cGlu): The glucose measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.

Lactate (cLac): The lactate measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.

Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.

Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.

Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.

Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the potential oxygen transport capacity; that is the fraction of oxyhemoglobins present (tHb) including dyshemoglobins.

Fraction of Carboxyhemoglobin (FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.

Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.

Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.

Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two B-chains, and has a higher oxygen affinity than adult Hb.

Creatinine (cCrea): The creatinine measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of

ABL800 FLEX with AQURE connectivity is a stationary, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions F02Hb, FCOHb, FMetHb, FHHb and FHbF).

The modification consists of integration with the Medical Device Data System (MDDS) called AQURE system. The software enables the initiation of device actions on connected ABL800 series analyzers.

The provided text is a 510(k) summary for the Radiometer ABL800 FLEX with AQURE connectivity. This document focuses on demonstrating substantial equivalence to a predicate device and addresses a software modification (integration with the AQURE system), not a study proving the original device's performance against detailed acceptance criteria for its clinical parameters.

Therefore, the information required to fully answer your request regarding performance criteria and a study proving the device meets those criteria for the measured clinical parameters (pH, pO2, pCO2, etc.) is not present in this document. This document specifically states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K041874 as modified by K043218, K050869, K051968, K100777 and K110416) still apply."

However, I can extract information related to the software modification and its acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for the software verification. The document mentions "test protocols" were used.
• Data Provenance: Not specified, but given it's a product from Radiometer Medical ApS in Denmark, it can be inferred that the testing likely occurred in a controlled lab or manufacturing environment. The study is retrospective in the sense that it relies on previously established performance data for the core ABL800 FLEX device and focuses on the impact of the new software integration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document does not mention the use of experts or ground truth establishment for the software verification. The assessment appears to be based on engineering and risk management principles (FMEA, test protocols).

4. Adjudication method for the test set

• Not applicable as this is a software modification verification, not a clinical study involving human judgment.

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

• No, an MRMC comparative effectiveness study was not done. The device is for in-vitro diagnostic testing (blood gas, electrolytes, metabolites, oximetry), not an imaging or interpretive AI device where MRMC studies are typically performed. The software modification is for data management connectivity (MDDS), not AI-assisted interpretation.

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

• The device itself (ABL800 FLEX) is a standalone automated diagnostic system. The AQURE connectivity is a software integration to manage data and device actions. The validation of the software integration focuses on its functionality and safety, not standalone diagnostic performance, as the diagnostic performance relies on the already established ABL800 FLEX analyzer.

7. The type of ground truth used

• For the software modification, the "ground truth" would be the expected functional behavior and safety requirements defined during the design and risk analysis phases. For example, a "ground truth" might be that a specific command sent via AQURE results in the correct action on the ABL800 FLEX analyzer, or that data transfer is accurate. However, this is not a biological or clinical ground truth.

8. The sample size for the training set

• Not applicable. This is a medical device connectivity software update and risk assessment, not a machine learning or AI algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable for the same reason as above.

In summary: This 510(k) summary explicitly states that the software modification (AQURE connectivity) does not affect the performance characteristics of the ABL800 FLEX analyzer. Therefore, performance data for the clinical parameters refers back to the original submissions (K041874 and subsequent modifications), which are not detailed in this document. The provided text only describes the verification and validation activities conducted for the software change itself, primarily focusing on risk management and functional testing rather than clinical performance studies.

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