Search Results

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 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

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

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 ALB, AST, CRBM, ALT, and TIBC 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.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for several reagent cartridges for the Dimension Vista™ system. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (Flex® reagent cartridges used on Dimension® clinical chemistry systems) due to a packaging modification. Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate devices.

The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." And in the conclusion: "Comparative testing also demonstrates substantially equivalent performance."

While explicit numerical acceptance criteria are not provided in the publicly available summary, the general acceptance criteria for this type of submission would be that the performance of the new device (Dimension Vista™ Flex® reagent cartridges) must be comparable or equivalent to the predicate device (Dimension® Flex® reagent cartridges). This comparison typically involves analytical performance characteristics such as:

• Accuracy: How close the measured values are to the true values.
• Precision: The reproducibility of measurements.
• Linearity/Measuring Range: The range over which the device accurately measures the analyte.
• Interferences: The effect of other substances on the measurement.
• Method Comparison: Correlation with the predicate device.

Since the submission states the reagents are the same, and only the packaging is modified for use on a different (but related) instrument, the expectation is that the analytical performance should remain unchanged or within acceptable variations for clinical use.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided summary. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't detail the sample sizes for comparison studies.
   • Data Provenance: Not explicitly stated. For in-vitro diagnostic devices, testing typically involves human serum and plasma samples, likely collected in a clinical laboratory setting. Whether it was retrospective or prospective is not mentioned, but validation studies for IVDs often involve prospective sample collection or the use of archived samples.

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

   • Not applicable as this is an in-vitro diagnostic test. Ground truth for such devices is established by the analytical performance against a reference method or validated calibrators, not by expert consensus in the way image analysis or clinical diagnosis might be.

3. Adjudication method for the test set:

   • Not applicable for an in-vitro diagnostic test. Results are quantitative measurements against established analytical standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is an in-vitro diagnostic device (reagent cartridge for laboratory analysis), not an AI-assisted diagnostic imaging or clinical decision support tool that involves "human readers."

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

   • Yes, this is an inherent aspect of an in-vitro diagnostic device. The "algorithm" here is the chemical assay and instrument processing. The performance reported (e.g., accuracy, precision) is the standalone performance of the device without human interpretation of the primary data, beyond standard laboratory quality control and result reporting.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
     • Reference Methods: Highly accurate and precise methods (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry for certain analytes) considered the gold standard.
     • Validated Calibrators/Controls: Materials with known, assigned values traceable to reference standards.
     • Clinical Diagnosis/Patient Outcome: For clinical utility, but analytical performance uses the above.
   • The document implies that the ground truth for comparison was the established performance of the legally marketed predicate devices, which would have been validated against such reference methods or standards.

7. The sample size for the training set:

   • Not explicitly stated. For reagent development, a "training set" in the context of machine learning isn't directly applicable. Instead, reagent formulations are optimized through R&D, and their performance is characterized using various samples (e.g., quality control materials, patient samples) during that development phase. The "study" described here is for validation, not training or development.

8. How the ground truth for the training set was established:

   • As noted above, a "training set" linked to a ground truth in the machine learning sense isn't directly relevant here. However, the development of the original reagents (predicate devices) would have involved extensive analytical characterization against reference methods and clinical samples to establish their performance specifications and clinical utility. The current submission leverages the established ground truth of these existing reagents.

Ask a specific question about this device

For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.

Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

The provided document describes the CARESIDE® ALT test system, an in vitro diagnostic device for quantitatively measuring Alanine Aminotransferase (ALT) activity. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria. Therefore, the document does not contain an "acceptance criteria" table in the traditional sense of a new clinical trial setting with predefined endpoints that need to be met for device approval. Instead, it presents a comparison of the CARESIDE ALT's performance characteristics against those of the predicate device (Vitros ALT DT Slides) to show "substantial equivalence."

Here's the information extracted and organized based on your request, focusing on the comparative performance data provided:

1. Table of Acceptance Criteria (Comparative Performance) and Reported Device Performance

As this is a 510(k) submission showing substantial equivalence, there are no explicitly stated "acceptance criteria" for a new device's clinical performance. Instead, the performance of the CARESIDE ALT is compared to the predicate device and the new device's performance is presented. The implicit "acceptance criterion" is that the CARESIDE ALT performs "as well as or better than" the predicate device.

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

The document does not explicitly state the sample size used for the "test set" (i.e., the number of patient samples or specimens used for the accuracy, precision, linearity, method comparison, and interference studies). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This type of information (experts, qualifications, etc.) is typically associated with studies involving human interpretation (e.g., image analysis, diagnoses). The CARESIDE ALT is an in vitro diagnostic device for quantitative chemical measurement. Its "ground truth" would be established by reference methods or laboratory-grade analyzers. Therefore, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where human readers interpret and classify data, and discrepancies need resolution. This is not applicable to a quantitative in vitro diagnostic device where measurements are compared to reference methods or statistical thresholds for performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The CARESIDE ALT is an in vitro diagnostic device for measuring a chemical analyte, not an AI-powered diagnostic system requiring human interpretation or assistance.

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

The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE ALT device, as it is an automated quantitative measurement system that does not involve human interpretation for its primary function.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics appears to be established using:

• Reference Method Comparisons: For accuracy and method comparison, the CARESIDE ALT measurements were compared against results from other established analytical methods, such as the "BM/Hitachi 902" analyzer and a "NADH/NAD coupled reduction of pyruvate by lactate dehydrogenase" reference method. The predicate device also refers to the "IFCC, 1978" method.
• Known Concentrations/Spiked Samples: For linearity, "linearity by mixing" was employed, suggesting known concentrations were used. Interference studies involved adding known concentrations of potential interfering substances.
• Statistical Analysis: Precision is determined through statistical analysis of replicate measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical assay, and its development would typically involve optimization and validation runs rather than a distinct "training set" in the computational sense. The document focuses on demonstrating the final product's performance.

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

As no "training set" in the AI/ML sense is mentioned, this question is not applicable to the information provided. The development of a chemical assay involves extensive R&D, optimization using laboratory standards, and clinical validation using patient samples, but these are not typically categorized as "training sets" with associated "ground truth establishment" in the way an AI algorithm would be described.

Ask a specific question about this device

Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers.

"Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "AST (GPT) Liquid Stable 2 Vial Reagent Incorporating DST." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter is primarily concerned with establishing substantial equivalence to a predicate device and discussing regulatory compliance.

Therefore, I cannot provide the requested information based on the given text. The text does not detail:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or study type (retrospective/prospective) for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results of a standalone algorithm-only performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for a training set.
9. How ground truth for a training set was established.

The letter explicitly states the device's indications for use: "Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers." It also references the use of Alanine aminotransferase (ALT/SGPT) measurements in the diagnosis and treatment of certain types of liver and heart diseases, as per CFR 862.1030. However, it does not provide performance metrics or study details to support these uses.

Ask a specific question about this device

Intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA® clinical chemistry system. This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030

Intended for the the In Vitro, quantitative determination of KAMYLASE (1,4-%- D glucan glucanohydrolase EC3.2.1.1) in human serum and urine on the Cobas MIRA ® clinical chemistry system. This Amylase test system is a device intended to measure the activity of the enzyme Amylase in serum and urine . Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) CFR 862.1070

Intended for the the In Vitro, quantitative determination of AST (Aspartate aminotransferase EC2.6.1.1) in human serum on the Cobas MIRA ® clinical chemistry system. This "aspartate aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liverand heart disease." CFR 862.1100

Intended for the the In Vitro, quantitative determination of Direct Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Direct Bilirubin test system is a device intended to measure the levels of bilirubin (direct) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

Intended for the the In Vitro, quantitative determination of Total Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Total Bilirubin test system is a device intended to measure the levels of bilirubin (Total) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

Intended for the the In Vitro, quantitative determination of Calcium in human serum or urine on the Cobas MIRA ® clinical chemistry system. This "Calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms" CFR 862.1145

Intended for the the In Vitro, quantitative determination of Total CO2 in human serum on the Cobas MIRA ® clinical chemistry system. This " bicarbonatel carbon dioxide test system is a device intended to measure the total bicarbonate/carbon dioxide plasma, serum and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid base balance. " CFR 862.1160

Intended for the the In Vitro, quantitative determination of Chloride in human serum on the Cobas MIRA ® clinical chemistry system. This " Chloride test system is a device intended to measure the Chloride in plasma, serum, sweat and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. " CFR 862.1170

Intended for the the In Vitro, quantitative determination of Cholesterol in human serum on the Cobas MIRA ® clinical chemistry system. This " Cholesterol test system is a device intended to measure the Cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. " CFR 862.1175

Intended for the In Vitro, quantitative determination of Creatinine in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Creatinine test system is a device intended to measure the Creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases,in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. " CFR 862.1225

Intended for the the In Vitro, quantitative determination of Glucose in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Glucose test system is a device intended to measure the Glucose levels in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus,neonatal hypoglycemia , idiopathic hypoglycemia and pancreatic islet cell carcinoma. " CFR 862.1360

Intended for the the In Vitro, quantitative determination of Iron in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron (non-heme) test system is a device intended to measure Iron (non-heme)in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia , hemochromatosis ( a disease associated with widespread deposit in the tissues of two iron containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin) and chronic renal disease. " CFR 862.1410

Intended for the In Vitro, quantitative determination of Magnesium in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnasemia (abnormally high levels of magnesium). " CFR 862.1495

Intended for the the In Vitro, quantitative determination of Inorganic Phosphorus in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases , and vitamin D imbalance. " CFR 862.1580

Intended for the the In Vitro, quantitative determination of Total Protein in human serum on the Cobas MIRA ® clinical chemistry system. This " Total Protein test system is a device intended to measure Total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as other metabolic or nutritional disorders " CFR 862. 1635

Intended for the the In Vitro, quantitative determination of Triglycerides in human serum on the Cobas MIRA ® clinical chemistry system. This " Triglyceride test system is a device intended to measure Triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. " CFR 862.1705

Intended for the the In Vitro, quantitative determination of Urea Nitrogen in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " urea nitrogen test system is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in whole blood, serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. " CFR 862.1770

Intended for the the In Vitro, quantitative determination of Unbound Iron-Binding Capacity (UIBC) in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron-binding capacity test system is a device intended to measure Iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. " CFR 862.1415

Intended for the the In Vitro, quantitative determination of Uric Acid in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Uric Acid test system is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. " CFR 862.1775

Not Found

The provided documents are Indications for Use (IFU) statements and an FDA 510(k) clearance letter for the TRACE Reagent Line for the Cobas MIRA. These documents state the intended use and regulatory classification of the device but do not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The documents merely confirm that the TRACE Reagent Line for the Cobas MIRA is cleared for marketing as substantially equivalent to existing devices for the in vitro quantitative determination of various analytes (ALT, Amylase, AST, Direct Bilirubin, Total Bilirubin, Calcium, Total CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Inorganic Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Unbound Iron-Binding Capacity, and Uric Acid) on the Cobas MIRA clinical chemistry system.

To answer your request, detailed performance study reports, often found in the 510(k) submission itself (which is typically not publicly available in its entirety without a FOIA request), or in peer-reviewed publications, would be necessary.

Ask a specific question about this device

For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.

Alanine Aminotransferase-SL Assay

This appears to be a 510(k) clearance letter from the FDA for an Alanine Aminotransferase-SL Assay. The document does not describe the acceptance criteria or the specifics of a study conducted to prove the device meets those criteria. Such information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document is essentially an approval letter stating that the device is substantially equivalent to a predicate device. It does not contain the detailed study results or acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device