(22 days)
Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System. The Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).
This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The CO2. CREA, and LDH reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
The provided 510(k) summary for K061238 describes the clearance of three reagent cartridges (CO2, CREA, and LDH) for the Dade Behring Dimension Vista™ system. This is a "Special 510(k)" submission, which is used for modifications to existing devices where the fundamental scientific technology and intended use remain unchanged. In this case, the modification is a packaging change to allow the use of pre-existing, cleared reagents on a new instrument system (Dimension Vista™).
Because this is a packaging modification for reagents already cleared on other Dimension® systems, the "acceptance criteria" and "device performance" in the traditional sense of a diagnostic algorithm's accuracy are not explicitly detailed in terms of sensitivity, specificity, or AUC. Instead, the focus is on demonstrating substantive equivalence in performance between the new packaging/instrument combination and the previously cleared predicate devices when using the same reagents.
The study described is a comparative testing study to demonstrate equivalent performance.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format of thresholds for sensitivity, specificity, or similar metrics for a diagnostic device that performs classification or detection. Instead, the acceptance criterion for this packaging modification submission is "equivalent performance" to the predicate device.
The "device performance" reported is that the comparative testing "demonstrates equivalent performance" and "substantially equivalent performance". This implies that the results obtained using the Dimension Vista™ with the new Flex® reagent cartridges for CO2, CREA, and LDH are comparable to those obtained with the predicate Dimension® systems using the same reagents.
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Equivalent performance to predicate devices | Comparative testing demonstrates equivalent performance. |
| Substantive Equivalence | Substantially equivalent in design, principle, and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." However, it does not provide any details regarding:
- The specific sample size used for the comparative testing.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the samples).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or not provided in this 510(k) summary. For a submission focused on equivalent analytical performance of clinical chemistry reagents, ground truth is typically assessed against established reference methods or by comparing results from the test device to the predicate device using patient samples or quality control materials. It does not involve expert readers establishing ground truth for diagnostic images or complex interpretations.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) to resolve discrepancies in expert opinions. This submission is for analytical chemistry reagents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance improves with or without AI assistance, which is irrelevant for a submission concerning in-vitro diagnostic reagents.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This submission is for IVD reagents used on an automated analyzer. The "standalone" performance here refers to the analytical performance of the combined reagent/instrument system. The document confirms that "Comparative testing...demonstrates equivalent performance," which implies the system's standalone analytical performance was evaluated against the predicate system. However, it's not an "algorithm-only" performance in the sense of AI.
7. The Type of Ground Truth Used
The "ground truth" for this type of submission is typically established by:
- Comparison to a legally marketed predicate device: The results from the new device are compared to those obtained from the predicate device using the same patient samples. Equivalence would be demonstrated through statistical methods (e.g., method comparison studies, regression analysis, bias analysis).
- Spiked samples or reference materials: To assess accuracy and linearity across the measuring range.
The summary states, "Comparative testing also demonstrates substantially equivalent performance," which strongly implies comparison to the predicate device using relevant samples.
8. The Sample Size for the Training Set
This information is not applicable or not provided. This submission is for IVD reagents, not a machine learning algorithm that requires a training set. The reagents themselves don't "learn" from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is not an AI/machine learning device that requires a training set and associated ground truth.
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.