Search Results

The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

• Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.

• Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.

The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.

The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Lite-On Technology Corp.'s Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, and Minicare C300 Clinical Chemistry Analyzer (K171971) were evaluated for substantial equivalence. The acceptance criteria and performance data are primarily based on precision, matrix comparison, detection limits, linearity, and interference testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance and the established clinical laboratory standards (e.g., CLSI guidelines, recovery within 90-110% for interference). The reported device performance aligns with these expectations.

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

• Internal Precision/Reproducibility: 80 runs per level (quadruplicate testing a day for 20 working days) for each of the three serum levels for all 5 analytes. Data provenance is not specified (e.g., country of origin) but refers to "patient serum samples." Implied prospective collection for the study.
• Matrix Comparison: 40 human samples. Data provenance not specified. Implied prospective collection for the study.
• Detection Limit: LoB: 60 measurements of a near-zero sample over 10 days. LoD/LoQ: serum samples containing very low concentrations, tested in triplicate using 2 lots of reagent discs for 10 days. Data provenance not specified. Implied prospective collection.
• Linearity: 9 intermediate dilutions created from high and low human serum pool samples, plus spiked samples. Data provenance not specified. Implied prospective collection.
• Endogenous Interferences: Not explicitly stated, but implies multiple samples to test two different concentrations (normal and abnormal) of analytes against specified interference levels. Data provenance not specified. Implied prospective collection.
• Exogenous Substances: Two concentrations (low and high level) of samples for each of the 10 potential interferents. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Method Comparison: Over 120 heparinized venous whole blood and serum samples for each analyte. Data provenance not specified; likely collected from the three POC sites, implying prospective collection.
• Point-of-Care (POC) Precision Studies: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Whole Blood Precision: Not explicitly stated, but tabular data suggests multiple analyses (mean, SD, CV) for low, medium, and high samples across 3 POC sites and multiple operators (OP1, OP2, OP3).

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

This type of submission (510k for a clinical chemistry analyzer) does not typically involve human experts establishing a "ground truth" for the test set in the same way an image analysis or diagnostic AI device would. Instead, the ground truth is established by:

• Reference Methods/Materials: Traceability to established reference methods (e.g., IFCC reference method for ALT/ALP/AST, CDC reference method for BUN, IDMS Reference Method for CREA) and reference materials (NIST SRM967).
• Comparative Clinical Analyzers: For method comparison studies, the Beckman Coulter AU2700 clinical analyzer served as the comparative (reference) method.

Therefore, the "experts" in this context are the established, validated, and traceable laboratory methods and instruments, rather than individual human practitioners.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic test performance for clinical chemistry analyzers is typically evaluated by statistical comparison to a reference method or established clinical ranges, not by an adjudication process as seen in clinical trial settings for diagnostic imaging.

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 is relevant for diagnostic imaging devices where multiple human readers interpret cases with and without AI assistance. This submission is for a clinical chemistry analyzer.

However, the "POC Precision studies" did evaluate performance across multiple operators (9 operators) at three POC sites. This demonstrates inter-operator variability, which is a related concept to multi-reader studies in a laboratory context, but it does not measure an "improvement with AI vs. without AI assistance" since the device itself is the primary measurement tool, not an AI assistant to a human reader.

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

Yes, the studies presented are generally "standalone" performance evaluations of the device (skyla/Minicare Clinical Chemistry Analyzer with Comprehensive Metabolic Panel) itself. The device automatically measures analytes and displays results; there isn't an "algorithm only" component separate from the integrated device performance. All performance data (precision, linearity, detection limits, interference) are solely based on the device's output.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Traceability to Reference Methods/Materials: For calibration and analytical accuracy (e.g., IFCC, CDC, IDMS reference methods, NIST reference materials).
• Comparative Clinical Analyzers: The Beckman Coulter AU2700 served as the comparative method for method comparison studies, essentially acting as the "ground truth" or reference for evaluating the test device's performance on patient samples.
• Known Concentrations: For studies like linearity, detection limits, and interference, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. This device is a traditional in-vitro diagnostic (IVD) clinical chemistry analyzer. Its development would involve internal validation and optimization processes by the manufacturer, which might loosely be considered "training," but it's not described as an AI model training set with a specific size or provenance.

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

As this is a traditional IVD device, the concept of a "training set" for an AI model's ground truth is not applicable in the way it would be for AI-powered diagnostic software. The "ground truth" for the development and internal validation of such a device is established through:

• Chemical Principles and Reactions: The underlying scientific principles of colorimetry and specific reagent reactions form the fundamental 'ground truth' for measurement.
• Calibration Standards: The device is calibrated using standards whose concentrations are traceable to recognized reference methods and materials, ensuring accurate quantitative measurements.
• Quality Control Materials: Known quality control materials are used to ensure the device performs within expected ranges over time.

These elements collectively serve as the basis for ensuring the device's accuracy and reliability during its design, development, and manufacturing phases.

Ask a specific question about this device

The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing.

Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories.

The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.

• Cuvette wash system .
• STAT facility .
• Direct interface with host computer .
• . Automatic re-run and pre-dilution functions

The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system.

Reagents:
AST reagent is supplied in a kit containing:

• . 4 x 20.0 mL Buffer/ enzyme
• . 4 x 7.0 mL α-οχοςlutarate/Coenzyme.

The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives.

ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.

Here's a summary of the acceptance criteria and study information for the RX Daytona Plus Instrument, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision, linearity, detection limit, analytical specificity, and method comparison studies. The device aims to demonstrate substantial equivalence to its predicate devices for each analyte (AST, Sodium, Potassium, Chloride) in the relevant sample types (serum, urine). The performance metrics reported directly represent if these implied criteria were met.

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

• Precision/Reproducibility:

  • AST, Sodium, Potassium, Chloride (Serum): Two levels of control material, calibration material, unaltered human serum samples, and altered human serum samples. Tested twice per day for 20 non-consecutive days, with two replicates per sample. This totals approximately 80 test points per sample type for control/calibrator, and 40 test points per patient pool (20 days * 2 replicates).
  • Sodium, Potassium, Chloride (Urine): Two levels of urine controls and two urine patient pools. Tested twice per day for 20 non-consecutive days, with two replicates per sample. Totals approximately 80 test points per control, and 40 test points per patient pool.
  • Data Provenance: Not explicitly stated, but the submission is from Randox Laboratories Limited in the United Kingdom, suggesting the studies were likely conducted there. The samples were human serum and urine. Retrospective or prospective nature is not specified, but the "non-consecutive days" suggests prospective testing over a period.

• Linearity/Assay Reportable Range:

  • AST, Sodium, Potassium, Chloride (Serum & Urine): Studies performed at 11 levels.
  • Data Provenance: Implied to be derived from the UK.

• Detection Limit (AST):

  • 360 determinations, with 1 blank and 2 low-level samples.
  • Data Provenance: Implied to be derived from the UK.

• Analytical Specificity (Interference):

  • Interferents (Hemoglobin, Bilirubin, Triglycerides, Intralipid, various drugs) were "spiked" into relevant control/sample solutions. The number of samples/replicates isn't specified beyond this.
  • Data Provenance: Implied to be derived from the UK.

• Method Comparison with Predicate Device:

  • AST (Serum): 92 serum patient samples.
  • Sodium (Serum): 50 serum patient samples.
  • Sodium (Urine): 42 urine patient samples.
  • Potassium (Serum): 56 serum patient samples.
  • Potassium (Urine): 43 urine patient samples.
  • Chloride (Serum): 61 serum patient samples.
  • Chloride (Urine): 44 urine patient samples.
  • All samples were tested in singlicate across 5 working days.
  • Data Provenance: Not explicitly stated, but given the submitter's location (UK), the data is most likely from the UK. The studies used "patient samples," which suggests real-world specimens, likely collected prospectively for the purpose of the study or retrospectively from a patient cohort.

• Expected Values/Reference-range Verification:

  • Sodium, Potassium, Chloride (Serum): Human serum from 30 normal donors, tested in singlicate.
  • Data Provenance: Implied to be derived from the UK.

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

Not applicable. This device is a clinical chemistry analyzer. The "ground truth" for the test set values (e.g., concentrations of AST, sodium) is established by reference methods or validated laboratory procedures, not by human expert interpretation like in imaging studies. The predicate device's performance also serves as a benchmark.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks, such as radiology image interpretation. In this context, the "ground truth" values for chemical analytes are obtained through highly standardized and quantitative laboratory methods (e.g., reference methods, predicate device results).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of AI on human readers' performance in diagnostic tasks (e.g., radiology). This device is a fully automated chemistry analyzer, not an AI-assisted diagnostic tool for human readers.

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

Yes, essentially all the performance data (precision, linearity, detection limits, analytical specificity, method comparison) reflects the standalone performance of the RX Daytona Plus Chemistry Analyzer as an automated instrument. There is no human-in-the-loop aspect for the analysis itself; human intervention is only involved in loading samples and interpreting the final results generated by the machine.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference materials/control materials: For precision and linearity studies.
• Validated methods/Predicate device results: For method comparison studies, where the results from the RX Daytona Plus were compared against a legally marketed predicate device (Randox RX Imola Chemistry Analyzer with ISE, Randox AST assay).
• Gravimetric preparation from purified salts: For ISE (Sodium, Potassium, Chloride) calibrators traceability.
• Standardized reference procedures (JSCC TS01): For AST traceability.
• Clinical literature: For establishing expected values/reference ranges.

8. The Sample Size for the Training Set

Not applicable. This is a traditional automated chemistry analyzer, not a machine learning or AI-driven device that requires a training set in the typical sense. The "parameters" and "algorithms" (e.g., Nernst equation for ISE, kinetic reaction for AST) are based on established chemical and physical principles, not learned from a large dataset.

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

Not applicable, as there is no "training set" for this type of device. The operating principles are based on fundamental scientific laws and established chemical diagnostic assays.

Ask a specific question about this device

The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the α-amylase activity in the sample.

In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in blood.

Here's an analysis of the provided information regarding the acceptance criteria and study for the ACE reagents:

Summary of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these in vitro diagnostic reagents (ALP, Amylase, ALT, AST) appear to be primarily demonstrated through comparisons with predicate devices and comprehensive performance characteristics like precision, linearity, and interference. The documentation focuses on demonstrating that the new devices perform equivalently to the existing predicate devices and meet established performance expectations for clinical chemistry assays.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document describes multiple reagents and doesn't explicitly state pass/fail acceptance values for each performance metric, I will summarize the demonstrated performance and what can be inferred as the "acceptance criteria" (i.e., that the results are comparable to established predicate device performance and within acceptable clinical ranges).

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

• Precision (Serum vs. Plasma):
  • In-House: Each dataset (low, mid, high for serum and plasma) involved "n=20" (number of replicates, likely over multiple days, contributing to within-run and total precision calculations).
  • POL Precision (ACE & Alera): For each analyte (ALP, AMY, ALT, AST) and each POL site (POL 1, POL 2, POL 3), there were 2 to 3 sample levels (Low, Mid, High), with a reported "n" for each (e.g., n=24 for ALT/AST in initial in-house, but the POL tables don't explicitly state the 'n' for each specific mean/SD/CV, implying a standard number of replicates as per precision studies).
• Matrix Comparison (Serum vs. Plasma):
  • ALP: ACE (108 pairs), ACE Alera (108 pairs), ACE Axcel (62 pairs).
  • Amylase: ACE (104 pairs), ACE Alera (101 pairs), ACE Axcel (52 pairs).
  • ALT: ACE (54 pairs), ACE Alera (52 pairs), ACE Axcel (56 pairs).
  • AST: The number of pairs for AST in the serum vs. plasma matrix comparison is not explicitly stated in the provided snippet. However, based on the pattern of other analytes, it would likely be similar (e.g., 50+ pairs).
• Method Comparison (In-House vs. POL Sites):
  • ALP: 49-50 samples per site.
  • Amylase: 51 samples per site.
  • ALT: 44-49 samples per site.
  • AST: 50 samples per site.
• Linearity: Not explicitly stated as an "n" for samples, but rather as "low level tested," "upper level tested," and "linear to" values, which typically involve preparing a dilution series from a high concentration sample.
• Data Provenance: The studies are labeled "In-House" and "POL" (Point of Care). This suggests:
  • Country of Origin: Likely the USA, given the FDA 510(k) submission.
  • Retrospective or Prospective: These types of performance studies for IVDs are typically prospective, with samples analyzed specifically for the study. The method comparison data often uses a mix of native patient samples and spiked samples to cover the measuring range.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This document describes the performance of IVD reagents on clinical chemistry systems. The "ground truth" here is not subjective, human interpretation (like in imaging AI), but rather the quantitative measurement of analytes.

• Number of Experts: Not applicable in the context of IVD reagent performance. The "ground truth" is established by the analytical method itself, or by comparison to a recognized reference method or a legally marketed predicate device.
• Qualifications of Experts: Not applicable. The "experts" would be qualified laboratory professionals operating the instruments and performing the biochemical assays according to established protocols.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "truth" for these quantitative measurements is derived directly from the biochemical reactions and instrument readings, not subjective human judgment requiring adjudication. The predicate device's established performance serves as a comparative benchmark.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a submission for in vitro diagnostic reagents, not an AI-assisted diagnostic device that involves human readers interpreting images or complex data. Therefore, an MRMC study is not relevant.

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

Yes, in essence, the performance data presented is "standalone" in the context of the device's function. The ACE reagents, when used on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, operate as an automated system to quantify the target analytes. The performance metrics (precision, linearity, method comparison, interferences) reflect the intrinsic analytical performance of the regent-analyzer combination without human intervention influencing the measurement itself. Human operators are involved in sample loading, quality control, and result review, but not in directly influencing the quantitative output in a way that would require a human-in-the-loop comparison for algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Comparison to Predicate Devices: The primary method is demonstrating substantial equivalence to previously cleared devices (K113253, K931786, K930104, K113436, K113382). This means the new reagents provide results that are analytically comparable to those already accepted by the FDA.
• Expected Analytical Performance: Meeting industry-standard requirements for precision (low CV%), accuracy (linearity, inter-instrument/site agreement via regression analysis), and specificity (minimal interference).
• Expected Values/Ranges: The devices are expected to produce results that align with established "expected values" for healthy individuals.

8. The Sample Size for the Training Set

Not applicable. These are chemical reagents for quantitative diagnostic tests, not machine learning algorithms that require a "training set" in the conventional sense. The "training" for such systems involves analytical validation experiments to define reagent stability, reaction kinetics, and instrument parameters.

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

Not applicable for the same reason as point 8. The "ground truth" for developing and validating these reagents is based on fundamental principles of analytical chemistry, biochemical reactions, and extensive internal testing to ensure the reagents perform as intended within the specified analytical parameters.

Ask a specific question about this device

The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.

The Hitachi Chemical Diagnostics S TEST Reagent Cartridges for Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) underwent nonclinical and clinical testing to demonstrate their safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Nonclinical Studies (Internal):
  • Analytical Sensitivity (LoD): Sample sizes not explicitly stated for individual calculations beyond "followed CLSI EP17."
  • Linearity: Sample sizes not explicitly stated beyond "followed CLSI EP-6A."
  • 20-day In-house Precision: 80 replicates per level for AST (ALT not clearly defined due to formatting issues in the document but likely similar).
  • Interference Testing: Sample sizes not explicitly stated.
  • Method Comparisons: 103 serum samples for ALT, 169 serum samples for AST.
  • Matrices Comparisons: Approximately 35 matched serum/plasma samples (28-31 for ALT, 38-39 for AST) per plasma type.
• Clinical Studies (External POL-type sites):
  • External Precision Study: 30 replicates per sample per site (6 times a day for 5 days) for 3 sample levels (A, B, C or D, E, F) at each of 3 sites.
  • External Method Comparisons: 49-50 blinded serum samples for ALT per site; 62-64 blinded serum samples for AST per site tested at 3 POL sites.
• Data Provenance: The document does not explicitly state the country of origin for the data. The studies were conducted internally ("in-house") and at "three external POL-type sites," suggesting the data is retrospective as it was collected before submission.

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

• For the nonclinical and clinical method comparison studies, the "ground truth" was established by "routine laboratory methods" or "traditional methods at the central laboratory."
• The document does not specify the number or qualifications of experts involved in performing these reference methods. It relies on the established accuracy and widely accepted nature of these "traditional" or "routine" methods.

4. Adjudication Method for the Test Set:

• No explicit adjudication method is described. The "ground truth" was derived from measurements by established laboratory methods, and the Hitachi device's results were compared to these.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This submission focuses on the analytical performance of an in vitro diagnostic (IVD) device (reagent cartridges for an analyzer), not a diagnostic imaging or AI-driven decision-support system that typically involves human reader performance. Therefore, there is no mention of human readers, AI assistance, or effect sizes related to human improvement.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

• Yes, this entire submission is effectively a standalone performance study. The device itself is an automated chemical analyzer with reagent cartridges. The studies evaluate the analytical performance of this automated system directly (e.g., sensitivity, linearity, precision, method comparison to reference methods). There is no "human-in-the-loop" component in the operational use or performance evaluation of the ALT/AST test results themselves, beyond the initial sample loading and result interpretation by laboratory personnel.

7. The Type of Ground Truth Used:

• The ground truth used for method comparison and accuracy studies was established by measurements from "routine laboratory methods" or "traditional methods at the central laboratory." This implies a highly accurate and well-established chemical assay, which serves as the reference standard for the analyte concentration or activity.

8. The Sample Size for the Training Set:

• This submission describes a premarket notification (510(k)) for an IVD device (reagent cartridges). It does not involve a machine learning or AI algorithm that typically requires a distinct "training set." Therefore, no training set sample size is reported or relevant in this context. The "training" of the device is inherent in its chemical design and calibration, not in data-driven machine learning.

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

• As stated above, this is an IVD device, not an AI/ML-driven device. Thus, the concept of a "training set" and associated ground truth establishment for such a set does not apply. The device's performance is validated against established laboratory standards and reference methods as described in point 7.

Ask a specific question about this device

The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma using the Hitachi Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total Billirubin measurements are used in the diagnosis and treatment of disorders of the liver.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Total Bilirubin.

Chemistry reaction: Nitrous acid method: Total bilirubin in samples is oxidized to biliverdin by the action of nitrous acid at pH 3.7. The concentration of total bilirubin can be determined by measuring the decrease of absorbance at a wavelength of 450nm .

Here's a breakdown of the acceptance criteria and the study details for the Hitachi S TEST Reagent Cartridge Total Bilirubin (T-BIL), based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for all performance characteristics in a single table. Instead, it presents various test results and implicitly suggests that these results are considered acceptable for demonstrating substantial equivalence to the predicate device.

However, based on the intended use and common analytical performance benchmarks for in vitro diagnostics, we can infer some criteria and list the reported performance:

2. Sample Sizes and Data Provenance

• Analytical Sensitivity (LoQ): Not specified for LoB and LoD. For LoQ, "three low level specimens in six runs over three [days] with three instruments."
• Linearity: 15 serial dilutions, plus the zero standard.
• 20-day In-house Precision: Four levels of samples, "each tested in two runs, twice a day, for 20 days." (Total of 80 measurements per level).
• Interference Testing:
  • Ascorbic acid and Hemoglobin: Two pools (approx. 1 and 4 mg/dL total bilirubin), spiked samples tested in triplicate.
  • Lipids: Three sets of serum samples with differing natural triglyceride levels and similar T-BIL, plus three sets of serum with low TG and similar T-BIL. Tested in triplicate.
• Method Comparison (Internal): 92 clinical specimens.
• Matrices Comparisons: 39 matched serum/plasma samples (sodium citrate, EDTA, lithium heparin).
• External Site Precision Study: Three blinded serum samples (A, B, C). Each sample assayed six times per day for five days, resulting in 30 replicates per level per site. (Total 90 replicates per sample level across 3 sites).
• External Method Comparison Studies: Approximately 50 serum specimens with total bilirubin values ranging from 0.4 to 38.1 mg/dL per site. (Total ~150 specimens across 3 sites).

Data Provenance: The document does not explicitly state the country of origin for the data. Given the address of the applicant (Mountain View, CA, USA) and the context of a 510(k) submission to the FDA, it is highly probable that the studies were conducted in the USA. All studies appear to be prospective as they were specifically designed and executed for this submission to evaluate the device's performance characteristics.

3. Number of Experts and Qualifications for Ground Truth

The document describes performance studies for an in vitro diagnostic device (reagent cartridge for total bilirubin). The "ground truth" in this context is typically established by a reference method or a standard laboratory system, not by human experts interpreting results.

Therefore, the concept of "number of experts used to establish the ground truth" and their "qualifications" as it applies to image analysis or diagnostic interpretation by humans is not applicable to this type of device and study. The comparison is against established chemical measurement techniques.

4. Adjudication Method

As the "ground truth" is established by chemical reference methods rather than human interpretation, an adjudication method (like 2+1 or 3+1 often used in imaging studies) is not applicable. The results are quantitative measurements compared against other quantitative measurements.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it be appropriate for this type of in vitro diagnostic device. MRMC studies are typically used to evaluate diagnostic accuracy and reader performance (e.g., radiologists, pathologists) for devices that involve human interpretation of images or other diagnostic data, often comparing AI-assisted vs. unassisted human performance.

This device, the "S TEST Reagent Cartridge Total Bilirubin (T-BIL)," is an automated chemistry assay that provides a quantitative measurement. There is no human "reader" in the loop whose performance would be improved by AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. All the studies described (analytical sensitivity, linearity, precision, interference, and method comparisons) evaluate the performance of the S TEST Reagent Cartridge Total Bilirubin when used with the Hitachi Clinical Analyzer E40, without human intervention in the result generation beyond operating the analyzer and collecting the samples.

The method comparison studies specifically compare the algorithm-generated result (from the S TEST T-BIL system) against results from a "standard laboratory system" or "comparative method," demonstrating its standalone performance.

7. Type of Ground Truth Used

The ground truth used for the performance studies was comparison against a standard laboratory system (or comparative method). For example:

• Linearity, Precision, Interference: These studies used prepared samples with known concentrations or manipulated matrices where the expected result provides the ground truth benchmark.
• Method Comparison (Internal & External): The results from the S TEST T-BIL system were compared against a "standard laboratory system" or a "comparative method" (implicitly, another cleared and accepted total bilirubin assay).
• Matrices Comparisons: Comparison was made between the T-BIL results in plasma types against serum using the same or an established method.

There is no mention of pathology, outcome data, or expert consensus in the setting of diagnostic interpretation, as this is a quantitative chemical measurement.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This is common for traditional in vitro diagnostic devices like reagent cartridges. These devices are developed based on established chemical principles (Nitrous acid method in this case) and tested for performance, rather than being "trained" using a dataset in the way an AI algorithm for image recognition would be.

Thus, the concept of a "training set" in the context of machine learning or AI is not applicable here. The development and validation process focuses on analytical performance characteristics.

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

Since there is no "training set" as understood in AI/ML, the question of how its ground truth was established is not applicable. The device's performance is validated against established laboratory standards and reference methods as detailed in section 7.

Ask a specific question about this device

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in serum.

In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.

This document describes the performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These reagents are intended for the quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (γ-GT) activity in serum, used in the diagnosis and treatment of certain liver and heart diseases.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as distinct from the reported performance. Instead, it presents the results of precision and accuracy studies. The implication is that these results demonstrate acceptable performance for the device. For the purpose of this table, the reported performance values are presented with the understanding that they met the internal requirements of the manufacturer for regulatory submission.

2. Sample Sizes Used for the Test Set and Data Provenance:

• ACE ALT Reagent:

  • Precision: Not explicitly stated as a "test set" sample size for patient samples. Precision was assessed at four ALT levels over 22 days in a lab setting and at three Physician Office Laboratory (POL) sites over 5 days. These studies would typically involve repeated measurements of control materials or pooled patient samples.
  • Accuracy: 102 samples for the main correlation study (ALT values from 4 to 472 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but the mention of Physician Office Laboratory (POL) sites suggests data from clinical settings. It is implied to be prospective data collected for the study, rather than retrospective.

• ACE AST Reagent:

  • Precision: Similar to ALT, assessed at four AST levels over 22 days in a lab and at three POL sites over 5 days.
  • Accuracy: 117 samples for the main correlation study (AST values from 8 to 440 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.

• ACE γ-GT Reagent:

  • Precision: Similar to ALT and AST, assessed at four γ-GT levels over 22 days in a lab and at three POL sites over 5 days.
  • Accuracy: 128 samples for the main correlation study (γ-GT values from 7 to 902 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.

The country of origin for the data is not specified, but the manufacturer is based in the US.

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

This information is not applicable as the device is an in vitro diagnostic (IVD) chemistry system that provides quantitative measurements of enzyme activity. The "ground truth" for IVD devices like this is typically established by comparing performance against a reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical assessments.

For accuracy, the device's performance was compared to the Alfa Wassermann ACE Clinical Chemistry System (predicate device K931786).

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human experts interpret results or clinical cases, and a consensus needs to be reached. For quantitative IVD tests, the "ground truth" is the result obtained from a reference method or predicate device.

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 information is not applicable. MRMC studies are relevant for medical imaging AI devices where human readers interpret images. This device is an in vitro diagnostic system for chemical analysis and does not involve human readers interpreting cases in the same way.

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

Yes, the performance studies described (precision, accuracy, and detection limit) represent the standalone performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These are objective, quantitative measurements generated directly by the analytical system, without human interpretation in the "loop" of the measurement process itself.

7. The Type of Ground Truth Used:

The ground truth used for the accuracy studies was the measurements obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System (K931786). The new reagents on the ACE Axcel system (y) were compared against the existing reagents on the ACE system (x) using patient samples. This is a common method for demonstrating substantial equivalence for new IVD devices by showing good correlation with an already legally marketed device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an in vitro diagnostic reagent and system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The reagents and system are developed and optimized through traditional chemical and engineering processes, followed by validation studies as described.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8. There is no training set in the machine learning context for this type of device.

Ask a specific question about this device

The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes. For in vitro diagnostic use only.

ELITech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELITech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Clinical Systems Selectra ProM analyzers.

ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.

ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.

ISE Sodium Electrode: The sodium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate anticluretic hormone secretion or other diseases involving electrolyte imbalance.

ISE Potassium Electrode: The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

ISE Chloride Electrode: The Chloride electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Selectra ProM is an automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically: the analyzer also has an ISE module for measuring sodium, potassium and chloride electrometrically. The Selectra ProM instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an ion selective electrodes (ISE).

AST/GOT 4+1 SL is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer. L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide. Reagent 2 contains α-Ketoglutarate, NADH and sodium azide.

The Sodium, Potassium and Chloride ISE Electrodes are comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HV according to FDA-approved methods in compliance with the European Directive 98/79/EC, Annex II, List A.

This document describes a 510(k) premarket notification for the ELITech Clinical Systems Selectra ProM, an automated in-vitro diagnostic analyzer, along with associated reagents and calibrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel performance. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of comparative performance to established predicate devices.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The document presents performance characteristics for the ELITech Clinical Systems Selectra ProM analyzer, the AST/GOT 4+1 SL reagent, and the ISE module (Sodium, Potassium, Chloride electrodes) by comparing them to predicate devices. The "acceptance criteria" are implied to be that the new device's performance is comparable to or better than the predicate's, thus demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit "acceptance criteria" (e.g., target CV% or r-squared values that must be met) are not directly stated as pass/fail thresholds but rather implied by comparison to predicates, I will present the comparative data provided. The reported performance of the ELITech device is compared directly against its predicate.

Interpretation: The reported performance indicators (e.g., CV for precision, r and r² for method comparison) are comparable to the predicate devices, supporting the claim of substantial equivalence. For instance, the AST reagent shows competitive precision and a strong correlation with the predicate method. Similarly, the ISE module demonstrates high correlation coefficients (r-values) when compared to its predicate.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., for method comparison or precision studies). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. It only mentions testing on "human serum and plasma."

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

This information is not provided in the document. For in-vitro diagnostic devices like clinical chemistry analyzers, "ground truth" is typically established by reference methods or established laboratory practices, not by expert consensus from medical professionals in a qualitative assessment sense. The document refers to "IFCC formulation" and "manual measurement" for AST traceability, and "primary calibrators prepared gravimetrically from purified salts" for ISE traceability, indicating reliance on established scientific and metrological standards rather than expert panel consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective expert review is involved (e.g., imaging diagnostics). For an in-vitro diagnostic device performing quantitative measurements, performance is typically evaluated against gold standard methods or established predicate devices using quantitative statistical comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of in-vitro diagnostic device. MRMC studies are primarily used for evaluating diagnostic imaging systems where human readers interpret images. This device performs automated chemical analysis, not human-interpreted diagnostic output. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies presented are effectively standalone performance evaluations for the ELITech Clinical Systems Selectra ProM analyzer and its reagents. The device is an automated system designed to perform measurements without direct human intervention in the analytical process. The method comparison and precision studies demonstrate the algorithm's (device's) performance in generating quantitative results. The human element is in operating the device and interpreting the results within a clinical context, but the performance data provided directly reflects the automated system's capabilities.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluations (e.g., method comparison studies) relies on:

• Reference Measurement Procedures/Established Methods: For AST, it mentions "IFCC formulation (Schumann, 2002), manual measurement" and comparison to a predicate that uses "IFCC modified method."
• Primary Calibrators/Metrological Traceability: For the ISE module, it states that the method has been standardized "against primary calibrators prepared gravimetrically from purified salts" and traces to "NIST SRM 919b" and "NIST SRM 918b" for Sodium and Potassium, respectively, and "NIST SRM 918b/919b" for Chloride.
• Predicate Device Measurements: In comparison studies, the results from the predicate devices (HORIBA ABX PENTRA 400 and ROCHE cobas c111 ISE) serve as the comparative standard.

8. The Sample Size for the Training Set:

This information is not applicable or not provided. Clinical chemistry analyzers and their reagents are typically developed and validated using a combination of laboratory-prepared samples, spiked samples, and patient samples. The term "training set" is more commonly associated with machine learning or artificial intelligence algorithms. While the instrument and reagent parameters are "trained" or optimized during development, specific sample sizes for such an internal "training set" are not disclosed in regulatory submissions of this type. The provided document details validation (test set) performance, not internal development/training data.

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

This information is not applicable or not provided for the reasons stated above in point 8. The "ground truth" for optimizing instrument parameters and reagent formulations during development would implicitly come from rigorous internal testing against known standards, reference materials, and established laboratory methods to ensure accuracy and precision across the measuring range.

Ask a specific question about this device

The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.

ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

The reagent device for this submission is available as kit only. It consists of 2 reagents:
Reagent 1 contains Tris buffer, L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide.
Reagent 2 contains alpha-Ketoglutarate, NADH and sodium azide
The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the ELITech Clinical Systems AST/GOT 4+1 SL device:

Device: ELITech Clinical Systems AST/GOT 4+1 SL reagent on Vital Scientific Selectra Junior Analyzer.

1. Table of Acceptance Criteria and Reported Device Performance

This submission focuses on demonstrating substantial equivalence to a predicate device (ABX PENTRA AST CP and Vitalab Flexor). The acceptance criteria are implicitly defined by demonstrating comparable performance to the predicate device within acceptable ranges for clinical diagnostic assays. The table below summarizes the performance metrics reported for the subject device.

• Level 21.2 U/L: CV=2.3%
• Level 46.4 U/L: CV=0.8%
• Level 203.4 U/L: CV=0.5% | These CVs (Coefficient of Variation) demonstrate good within-run reproducibility. |
  | | | Total:
• Level 21.2 U/L: CV=3.8%
• Level 46.4 U/L: CV=1.2%
• Level 203.4 U/L: CV=2.7% | These CVs demonstrate good total precision. |
  | Method Comparison | Strong correlation with predicate (e.g., R² > 0.98, slope ~1, intercept ~0) | $y = 1.016x - 1.86$ U/L
  $R^2 = 0.9998$
  Range: 9.5 to 234.4 U/L | Excellent correlation ($R^2=0.9998$) to the predicate method, indicating substantial agreement over the tested range. The slope is very close to 1 and the intercept close to 0. |
  | Measuring Range | Comparable to predicate for clinical utility (Predicate: 3.70 U/L to 600 U/L) | 10 to 250 U/L (with automatic post-dilution up to 1800 U/L) | While the initial measuring range is narrower than the predicate, the automatic post-dilution extends it significantly, indicating broader clinical utility or comparable range with dilution. |
  | Calibration Frequency | Clinically acceptable stability (Predicate: 8 days) | 28 days | Improved calibration frequency compared to the predicate, indicating better stability. |
  | On-board Stability | Clinically acceptable stability (Predicate: 55 days) | 28 days (refrigerated area) | Slightly shorter, but still well within typical clinical laboratory operational periods for on-board reagents. |

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

The provided document does not explicitly state the specific sample sizes used for the precision and method comparison studies. However, for diagnostic device submissions, "levels" (e.g., Level 21.2 U/L, Level 46.4 U/L, Level 203.4 U/L for precision studies) typically refer to replicates of control materials or pooled patient samples at different concentrations. A method comparison study using a range of 9.5 to 234.4 U/L implies a set of patient samples covering a broad clinical range.

• Sample Size for Test Set: Not explicitly stated for each study, but implied to be sufficient for statistical analysis of precision (CVs) and method comparison ($R^2$ and linear regression parameters).
• Data Provenance: The submitter is SEPPIM S.A.S. located in France. The studies were likely conducted in a setting compliant with regulatory standards (e.g., GLP/GCP-like principles) for diagnostic device validation. The document does not explicitly state if the samples were retrospective or prospective, nor does it specify the country of origin for the patient samples, but given the manufacturer's location, the data most likely originates from France or other European countries.

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

The device is a quantitative clinical chemistry assay for AST. For such assays, "ground truth" is typically established by comparing the results of the new device to a legally marketed predicate device or a reference method, rather than through expert consensus on individual results.

• The ground truth for the method comparison study was established by the predicate device (ABX PENTRA AST CP) or a method traceable to IFCC formulation.
• Number of Experts: Not applicable in the context of establishing ground truth for a quantitative biochemical assay. Experts are involved in setting the performance specifications and interpreting the results, but not in generating the "ground truth" values for the samples themselves in this type of study.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or other diagnostic scenarios where human interpretation is subjective and consensus among experts is needed to establish a definitive "ground truth" diagnosis.

• Adjudication Method: Not applicable. For quantitative biochemical assays, the comparison is made directly between the numerical results of the candidate device and the predicate/reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI

• MRMC Study: No, this is not an MRMC comparative effectiveness study. This device is a fully automated in vitro diagnostic (IVD) reagent and analyzer system, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation involving multiple readers.
• Effect Size of Human Improvement with/without AI: Not applicable, as there is no human-in-the-loop interaction or AI component discussed for this specific diagnostic device in the provided text.

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

• Standalone Performance: Yes, the performance data presented (precision, method comparison, measuring range, calibration frequency, on-board stability) represents the standalone performance of the ELITech Clinical Systems AST/GOT 4+1 SL reagent when used on the Vital Scientific Selectra Junior Analyzer. It describes the direct analytical capabilities of the system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The primary type of ground truth used for performance evaluation (specifically, method comparison) is comparison to a legally marketed predicate device/method (ABX PENTRA AST CP, optimized UV test according to IFCC modified method without pyridoxal phosphate). For precision, it's based on repeated measurements of control materials or pooled samples.

8. The Sample Size for the Training Set

This submission describes a diagnostic reagent and analyzer system, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The development of such chemical reagents and assay protocols does not involve machine learning training data.

• Sample Size for Training Set: Not applicable.

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

As there is no "training set" for this type of IVD device, this question is not applicable. The development of the reagent assay formulation (Modified IFCC method without pyridoxal-phosphate) is based on established biochemical principles and extensive R&D, rather than machine learning on a dataset with pre-established ground truth.

Ask a specific question about this device

The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation:

L-Aspartate + 2-Oxoglutarate L-Glutamate + Oxalacetate

Oxalacetate + NADH + H' L-Malate + NAD*

Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients .

TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

The furnished document is a 510(k) premarket notification for an in vitro diagnostic device, the DiaSys ASAT (GOT) FS assay, TruCal U calibrator, and TruLab N and TruLab P controls. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive independent clinical study data with predefined acceptance criteria as might be seen for novel devices.

Therefore, the information regarding acceptance criteria and a detailed study proving the device meets these criteria is limited and primarily presented in the context of comparison to the predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the studies in the same way a clinical trial would. Instead, it presents performance characteristics and compares them to the predicate device, implying that equivalence to the predicate's performance is the de facto acceptance criterion.

Ask a specific question about this device

The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate.

The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-alpha-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate.

The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and alpha-ketoglutarate as substrates.

Here's a summary of the acceptance criteria and study details for the S-Test ALP, AMY, and AST reagent cartridges, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance, which demonstrates substantial equivalence to predicate devices. The study compares the performance of the S-Test reagents on the S40 Clinical Analyzer against comparison methods.

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

• S-Test ALP:
  • Accuracy (Correlation Study): 180 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites, implying a collection of patient samples.
• S-Test AMY:
  • Accuracy (Correlation Study): 196 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.
• S-Test AST:
  • Accuracy (Correlation Study): 177 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.

Data Provenance: The studies were conducted "in-house" and at "three/four separate Physician Office Laboratories (POL) sites." This suggests a mix of laboratory and real-world clinical settings, likely within the US given the submission to the FDA. The data is presented as if it's from prospective collection for the study, as it involved assaying samples on the new device and a comparison method.

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

This information is not provided in the summary. The study relies on "comparison methods" to establish the reference values for the samples, rather than human expert interpretation of raw data. The performance is assessed by comparing the S-Test results to these established comparison methods.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by "comparison methods" (presumably other validated IVD assays), not by human interpretation requiring adjudication.

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

An MRMC comparative effectiveness study was not performed. This submission is for an in vitro diagnostic (IVD) reagent cartridge for quantitative determination of analytes, not a device requiring human interpretation of images or other qualitative data that would benefit from an MRMC study with human readers (or AI assistance).

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

This study is inherently a standalone performance evaluation of the reagent cartridges used with the S40 Clinical Analyzer. The "algorithm" here is the enzymatic photometric test and the analyzer's processing of the photometric data to produce a quantitative result. The performance data presented (precision, accuracy, sensitivity) directly reflects the standalone capabilities of the device without human intervention in the result generation process itself.

7. The type of ground truth used

The ground truth was established by "comparison methods." This refers to existing, legally marketed, and presumably validated IVD assays for ALP, AMY, and AST. The performance of the S-Test reagents was compared directly to the results obtained from these comparison methods on the same samples.

8. The Sample Size for the Training Set

This information is not provided. As these are chemical reagents and an analyzer system, there isn't a "training set" in the sense of machine learning algorithms that learn from data. The reagents and analyzer system are developed and validated through chemical and engineering principles.

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

This information is not applicable as there is no mention of a "training set" in the context of this IVD device. The development and validation of such a system would involve extensive analytical characterization (e.g., linearity, interference, stability) and verification against known standards and reference materials, rather than a data-driven "ground truth" for training.

Ask a specific question about this device