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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.

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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.

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Activated 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 liver and heart disease.

Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.

Here's an analysis of the provided text regarding the Abbott Laboratories Activated AST assay, structured to address your specific points:

Since this document describes a diagnostic assay and not an AI/ML device, many of the requested points related to AI/ML specific studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable. The study design described is a comparative performance study against a predicate device, which is standard for in vitro diagnostic (IVD) assays for 510(k) clearance.

Acceptance Criteria and Study Summary for Abbott Laboratories Activated AST Assay

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly defined by the demonstration of comparable performance to the predicate device, specifically in terms of correlation (regression analysis) and precision.

• ARCHITECT c8000: 0.999 (slope 1.01, Y-intercept -4.15 U/L)
• ARCHITECT c16000: 0.999 (slope 1.03, Y-intercept -3.75 U/L) |
  | Precision (Total %CV) | Acceptable within-laboratory precision for different AST levels (typically varies by concentration). | ARCHITECT c8000:
• Level 1 (43 U/L): 4.5% (20 Day)
• Level 2 (192 U/L): 1.0% (20 Day)
• Level 3 (23 U/L): 2.4% (5 Day)
• Level 4 (3,437 U/L): 0.7% (5 Day)
  AEROSET System:
• Level 1 (46 U/L): 2.3% (5 Day)
• Level 2 (205 U/L): 0.7% (5 Day)
  ARCHITECT c16000 System:
• Level 1 (45 U/L): 1.8% (5 Day)
• Level 2 (197 U/L): 0.5% (5 Day) |
  | Linearity | Demonstrate accuracy across a clinically relevant range. | Linear up to 1,985 U/L. |
  | Limit of Quantitation (LoQ) | Define the lowest concentration that can be accurately measured. | 5 U/L (with Flex Rate linearity up to 5,364 U/L). |

The study demonstrates that the Abbott Laboratories Activated AST assay on various Abbott platforms (AEROSET, ARCHITECT c8000, ARCHITECT c16000) achieves a very high correlation (0.999) with the predicate device (Abbott AST Activated, K981221) on the AEROSET System. The reported precision (total %CV) values are varied but generally low, indicating good reproducibility. The linearity and limit of quantitation also support the device's performance across its intended measuring range.

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

• Sample Size for Test Set: The document does not explicitly state the number of samples used for the method comparison (correlation) or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted," providing the results without specific sample counts for each.
• Data Provenance: The document does not specify the country of origin of the data. Given the "Abbott Laboratories" submitter in Irving, TX, USA, it is highly probable the studies were conducted in the USA. The studies are prospective in nature, as they involve running samples on the new device and comparing them to a predicate device, which implies collecting or generating data for the specific purpose of the 510(k) submission.

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

This is not applicable as this is an in vitro diagnostic assay, not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this assay is the measurement obtained from the legally marketed predicate device, which itself would have undergone rigorous validation.

4. Adjudication Method for the Test Set

Not applicable for an in vitro diagnostic assay. Performance is assessed by direct comparison of numerical results to the predicate device and established analytical performance metrics (e.g., correlation, precision).

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

Not applicable. This is an in vitro diagnostic assay, not an AI/ML device for aiding human readers.

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

For an IVD, the "standalone" performance is essentially what is evaluated. The device itself (reagents + instrument system) performs the measurement. The results of the comparative performance studies and precision studies represent the standalone performance of the assay. There isn't an "algorithm only" in the sense of AI/ML, but rather the chemical reaction and photometric measurement by the instrument.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Abbott AST Activated assay, K981221 on the Abbott AEROSET System). The goal is to show the new device yields "similar results" and "similar Performance Characteristics" to this predicate.

8. The Sample Size for the Training Set

Not applicable. This is an IVD assay, not an AI/ML device that requires a training set in that context. The "training" for such a system would involve method development and optimization, but not in the sense of machine learning.

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

Not applicable, as there is no "training set" in the context of an AI/ML device. For an IVD, the initial method development and optimization would rely on established analytical chemistry principles and potentially reference methods, but this is distinct from establishing ground truth for machine learning.

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The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

Auxiliary product: Pyridoxal Phosphate
Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

For eCal Calibrator, Nortrol and Abtrol see intended use.

Not Found

The provided submission describes an in vitro diagnostic device (IVD) for the quantitative determination of aspartate aminotransferase (AST/GOT) activity. It is not an AI/ML powered device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set) are not applicable.

Here's the breakdown of the acceptance criteria and study information provided for the AST/GOT (IFCC) device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to those of the predicate device (Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)). The goal is to demonstrate "substantial equivalence."

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cobas c 111 analyzer:

The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices.

Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Reagents:

Aspartate aminotransferase (ASTL/ASTPL) In vitro test for the quantitative determination of AST in human serum and plasma on the cobas c1 11 system. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

C-Reactive Protein Latex (CRPLX)

In vitro test for the quantitative immunological determination of human C-reactive protein in human serum and plasma on the cobas c111 system. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Glucose HK (GLUC2)

In vitro test for the quantitative determination of glucose concentration in human serum and plasma on the cobas c111 system. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.

ISE Chloride Electrode

The chloride electrode for the cobas c111 system is intended for the quantitative determination of chloride in diluted serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ISE Potassium Electrode

The potassium electrode for the cobas c111 system is intended for the quantitative determination of potassium in diluted serum, plasma, and urine. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

ISE Sodium Electrode

The sodium electrode for the cobas c111 system is intended for the quantitative determination of sodium in diluted serum, plasma, and urine. Measurements of sodium are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (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 antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The Roche cobas c 111 analyzer is an 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 optional ISE module for measuring sodium, potassium and chloride.

The provided 510(k) summary (K071211) describes the cobas c 111 Analyzer and its applied reagents. This submission is for a modification to the device, extending its intended use to include point-of-care settings, in addition to professional use. The study presented compares the performance characteristics of certain reagents (AST, Glucose, CRP, ISE-Cl, ISE-K, ISE-Na) on the cobas c 111 analyzer for both professional use (as cleared in K063744) and the proposed point-of-care use, to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analyte are implicitly defined by demonstrating that the "Reagent performance characteristics for point-of-care use" are comparable to or within acceptable limits of the "Reagent performance characteristics on cobas c 111 analyzer for professional use." The main performance metrics evaluated are:

Acceptance Criteria (Implicit Summary): The acceptance criteria are based on demonstrating substantial equivalence between the performance of the cobas c 111 analyzer and its reagents for the new point-of-care intended use and its established professional use, primarily by showing comparable precision, analytical sensitivity, measuring range, interference profiles, and method comparison results against a predicate device (Integra 400). The word "Same" is frequently used, indicating that the performance metrics achieved for the professional use are expected to be maintained for the point-of-care use. Significant deviations would require further justification or modification.

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

The "test set" in this context refers to the samples used to evaluate the device's performance for the new point-of-care intended use. These samples are detailed in the "Method Comparison" section:

• Test Set Sample Sizes:
  • AST: n = 333 (for point-of-care use)
  • Glucose: n = 333 (for point-of-care use)
  • CRP: n = 326 (for point-of-care use)
  • ISE-Cl: n = 280 (for point-of-care use)
  • ISE-K: n = 280 (for point-of-care use)
  • ISE-Na: n = 280 (for point-of-care use)
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the data was retrospective or prospective. However, the study focuses on in-vitro diagnostic performance using human serum, plasma, and urine samples. The nature of performance studies for in-vitro diagnostics typically involves prospective collection of samples or use of archived, de-identified human biological samples that cover the relevant measuring ranges.

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

For in-vitro diagnostic devices like the cobas c 111 analyzer, "ground truth" and "experts" are typically interpreted differently than in imaging or AI-driven diagnostic studies.

• Ground Truth: The ground truth for this device is established by a reference method or a predicate device with a known and established measurement accuracy. In this case, the Integra 400 system is used as the comparative method. The values obtained from the Integra 400 are considered the reference or "ground truth" for comparison.
• Experts: The study design does not involve human experts establishing a diagnostic "ground truth" through interpretation. Instead, the "expertise" lies in the established analytical performance characteristics, calibration, and standardization of the Integra 400 and the rigorous laboratory practices followed during the study.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where human readers or experts are interpreting results and consensus is needed to establish ground truth or resolve discrepancies, particularly in imaging or pathology.

• No Adjudication Method: For this type of in-vitro diagnostic device performance study, there is no mention or indication of an adjudication method. The comparison is quantitative between the device under test (cobas c 111) and the predicate device (Integra 400), based on measured numerical values. Statistical methods (e.g., Passing-Bablok regression, correlation coefficients) are used to analyze the agreement between the two methods, not an adjudication process.

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

No, an MRMC comparative effectiveness study was not done.

MRMC studies are primarily used in diagnostic imaging or other fields where multiple human readers interpret cases, and the study aims to assess how an AI system might affect their performance (e.g., improving accuracy, reducing reading time). This submission is for an in-vitro diagnostic device, which outputs quantitative measurements, and its performance is evaluated through analytical correlation and precision, not human interpretation.

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

Yes, a standalone performance evaluation was done.

The data presented directly evaluates the performance of the cobas c 111 analyzer (an automated system performing the "algorithm" of chemical analysis) and its reagents without direct human intervention in the measurement process itself. The "human-in-the-loop" here refers to the operator initiating the test and interpreting the result, but the analytical performance data (precision, method comparison) reflects the device's inherent capability. The expansion to "point-of-care" suggests a different type of operator, but the core analytical engine operates independently for measurement.

7. The Type of Ground Truth Used

The type of ground truth used is based on comparison to a legally marketed predicate device (Integra 400) and established reference methods/standards.

• For method comparison, the results from the Integra 400 are considered the reference.
• For traceability and standardization, internationally recognized standards and methods are used (e.g., IFCC formulation for AST, ID/MS for Glucose, IRMM - BCR470/CRM470 for CRP, gravimetrically prepared primary calibrators for ISE). These constitute the ultimate "ground truth" for the accuracy of measurements.

8. The Sample Size for the Training Set

The document does not specify a training set sample size.

This is because the cobas c 111 is a clinical chemistry analyzer, not a machine learning or AI algorithm in the contemporary sense that learns from a training dataset. The "training" of such a device involves:

• Engineering design and optimization
• Method development for specific reagents
• Calibration using master calibrators.

The performance characteristics (measuring range, sensitivity, precision, interference) are established through analytical validation studies, not by training a computational model on a large dataset. The reagents themselves have defined formulations and reaction kinetics.

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

As mentioned above, the concept of a "training set" and associated "ground truth" in the machine learning sense does not apply directly to this in-vitro diagnostic analyzer.

Instead, the analytical "ground truth" is established through:

• International standards and reference materials: Such as IFCC, ID/MS, and IRMM standards mentioned in the "Traceability/Standardization" section. These provide the accurate values for calibration and control materials.
• Validated reference methods: The Integra 400 itself is a validated instrument used as a comparison method, implying its results are considered accurate and reliable.

The device is calibrated using these standards and validated against reference instruments to ensure its measurements are accurate and consistent.

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Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA AST CP reagent, ABX PENTRA Multical, ABX PENTRA N Control, and ABX PENTRA P Control, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Kinetic Method. The principle is based on the following reaction system: GOT (AST) L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H + → L-Malate + NAD + The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST). AST or GOT: Aspartate Aminotransferase. MDH: Malate Dehydrogenase. NADH: Nicotinamide-Adenine Dinucleotide (Reduced) NAD + : Nicotinamide-Adenine Dinucleotide. H + : Proton.

The provided document describes the "Wiener lab. GOT (AST) UV AA Líquida" test system, a quantitative in vitro diagnostic device for determining aspartate aminotransferase (AST or GOT) in human serum and plasma. The device's performance is compared to a predicate device, "Wiener lab. GOT (AST) UV," to establish substantial equivalence.

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

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing key performance characteristics. The "acceptance criteria" are implicitly set by matching or improving upon the performance of the predicate device.

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

The document does not explicitly state the sample sizes used for the precision and linearity studies. It only provides the results (e.g., CV values and linearity range). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

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

This information is not applicable in this context. This device is a quantitative diagnostic assay, not an imaging or interpretive diagnostic tool that requires expert human interpretation to establish ground truth for testing. The "ground truth" for linearity and precision studies would be derived from the known concentrations or activities of reference materials, or statistical analysis of repeated measurements, not expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This is not applicable for the type of device and studies presented. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or other data where consensus among experts is needed.

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 is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers.

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

This is not applicable in the sense of an "algorithm only" performance. The device is a chemical reagent system. Its performance (precision, linearity) is inherently "standalone" in the context of the assay itself, as it measures a biochemical parameter directly. There is no human interpretative "loop" in the direct performance of the assay.

7. The Type of Ground Truth Used:

For linearity, the ground truth would be based on known concentrations or activities of control materials or serially diluted samples.
For precision, the ground truth is established statistically by repeated measurements on stable control materials or patient samples to assess the reproducibility of the assay.

8. The Sample Size for the Training Set:

The document does not specify a training set in the context of machine learning or AI. For a traditional in vitro diagnostic assay like this, there isn't a "training set" in that sense. The assay's parameters (reagent concentrations, reaction conditions) are developed through chemical and biochemical optimization, often involving many experiments, but not a formally defined "training set" of patient data as would be found in AI/ML development.

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

As there is no "training set" in the context of AI/ML for this device, this question is not applicable. The "ground truth" for the development of reagent formulations and assay conditions would be based on established biochemical principles, analytical chemistry standards, and experimental results aimed at optimizing the reaction kinetics and stability.

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Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers.

Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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This document is a 510(k) clearance letter for an in vitro diagnostic device, the AST (SGOT) REAGENT. It is a regulatory approval, not a scientific study report. Therefore, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.

The document only states the "Indications for Use":

Device Name: AST (SGOT) REAGENT

Indications for Use: Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

To answer your request, a separate study report or a more detailed filing from JAS Diagnostics, Inc. to the FDA would be needed. This letter primarily confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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The WIENER LAB GOT (AST) UV test system is an I.V.D. device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The principle is based on the following reaction system: GOT L-aspartate + 2-oxoglutarate -> oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H+ -> I-Malate + NAD+ AST or GOT: Aspartate Amino transferase MDH: Malate Dehydrogenase

This document describes the 510(k) summary for the "WIENER LAB. GOT(AST) UV" test system, an in vitro diagnostic device for quantitative determination of aspartate amino transferase (AST/GOT) in human serum and plasma. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the sense of a standalone performance study with predefined acceptance thresholds.

However, based on the provided text, we can extract information regarding what would constitute "acceptance" for this type of device in the context of a 510(k) submission, which is demonstrating substantial equivalence to a predicate device. The performance characteristics of the WIENER LAB. device are presented in comparison to the predicate device (RANDOX AST ASAT GOT OPT. test system) to show this equivalence.

Here's an attempt to structure the information based on your request, understanding that the "acceptance criteria" here are implicitly linked to the predicate device's performance and the demonstration of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are often relative to the predicate device's performance. The WIENER LAB. GOT (AST) UV device is designed to be substantially equivalent to the RANDOX AST ASAT GOT OPT. test system. The table below compares key performance characteristics. The implicit acceptance criterion is that the WIENER LAB. device's performance characteristics are comparable or better than the predicate device, or within acceptable clinical limits.

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

The document does not explicitly specify a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical validation study in the traditional sense. The data provided in the table are performance characteristics typically derived from analytical verification studies (e.g., linearity, precision, detection limit). These studies are generally conducted by the manufacturer as part of product development and validation.

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

Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for performance characteristics like precision and linearity comes from established laboratory methods and statistical analysis.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves quantitative chemical measurement, not expert adjudication of results.

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

Not applicable. This is an in vitro diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers/clinicians.

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

This device is a standalone diagnostic test system. Its performance characteristics (linearity, precision, detection limit) are measured directly from the assay without human interpretation in the results generation process. The "standalone" performance is the data presented in the table.

7. The Type of Ground Truth Used

The ground truth for the performance characteristics (linearity, precision, detection limit, expected values) is established through accepted analytical chemistry and laboratory standards. For instance:

• Linearity: Determined by testing known concentrations of analytes and assessing the correlation between measured and expected values.
• Precision: Determined by repeatedly measuring samples (e.g., control sera) and calculating statistical measures like Coefficient of Variation (CV).
• Expected Values: Established through studies of healthy populations using established reference methods.

8. The Sample Size for the Training Set

Not applicable. This document describes an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this type of device.

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