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The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.

The S-Test LD Reagent cartridge is intended for the quantitative in vitro diagnostic determination of LD activity in serum, used with the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma of the liver), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation coefficient: 0.9857
• Standard error estimate: 19.8
• Confidence interval slope: 0.934 to 1.008
• Confidence interval intercept: -13.3 to 2.7
  POL sites (4 sites):
• Correlation coefficients: 0.9971 to 0.9989
• Standard error estimates: 6.4 to 10.5
• Confidence interval slopes: 0.941 to 1.001
• Confidence interval intercepts: -11.1 to 11.0 |
  | Detection Limit | Low (e.g., clinically relevant lower bound) | 9 U/L |

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

• Sample Size for Accuracy Study (In-house): 81 samples
• Sample Size for Accuracy Studies (POL sites): Not explicitly stated, but implies multiple samples were tested at each of the four separate POL sites.
• Sample Size for Precision Study (In-house): Not explicitly stated how many individual measurements contributed to the CVs, but involved testing at three LD levels over 22 days.
• Sample Size for Precision Study (POL sites): Not explicitly stated, but involved testing at three separate POL sites over 5 days.
• Data Provenance: The studies were conducted "in-house" (presumably by Alfa Wassermann Diagnostic Technologies, LLC, in the US) and at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," indicating that data was collected from various clinical settings. Given the submitter's location in New Jersey, USA, and the FDA submission, it's highly probable the data is from the United States. The studies appear to be prospective as performance specific to this device and its use with the S40 Clinical Analyzer was generated.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for the test set is established by a comparative, legally marketed method (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent), not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring a biochemical marker against a comparative method, there is no human adjudication involved in establishing the "ground truth." The comparison is a direct numerical correlation between the S-Test LD and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an in vitro diagnostic test for quantitative determination of an analyte (LD activity). MRMC studies are typically performed for diagnostic imaging or pathology devices where human readers interpret medical images or samples.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this describes the primary performance evaluation. The S-Test LD Reagent cartridge, when used with the S40 Clinical Analyzer, performs the quantitative measurement of LD activity without human interpretation in the results generation. The performance data presented (precision, accuracy, detection limit) are direct technical performance characteristics of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies was established by comparison to a legally marketed predicate device (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent) using the "comparative method." This is a common and accepted method for establishing the performance equivalence of new IVD assays.

8. Sample Size for the Training Set

Not applicable. This is a biochemical reagent and analyzer system, not a machine learning or AI-based device that requires a "training set" in the conventional sense of artificial intelligence. The device's operational parameters and calibration procedures are established through manufacturing and quality control, not through a data training pipeline.

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

Not applicable. As mentioned above, there is no "training set" for this type of IVD device in the context of machine learning. The operational characteristics and performance specifications are inherent to the chemical reactions and instrumental design, validated through standard analytical performance studies.

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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.

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.

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