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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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