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The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total protein measurements 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.

The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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 Cartridges TP and ALB.

Chemistry reactions: (TP) Proteins in samples react with the biuret reagent to form a purplered complex. The concentration of total protein can be determined by measuring the absorbance of the purple-red substance.

(ALB) Albumin in the sample combines with bromcresol green to form a blue-green dye conjugate. The albumin concentration is directly proportional to the color intensity and can be determined photometrically by measuring the absorbance of this resulting blue-green color.

The provided document is a 510(k) summary for the Hitachi S TEST Reagent Cartridge Total Protein (TP) and Albumin (ALB). It details the nonclinical and clinical studies performed to demonstrate the safety and effectiveness of these in-vitro diagnostic devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a singular, formal table. Instead, performance characteristics are presented as results from various studies, often implicitly comparing them to the predicate device or general industry standards (e.g., CLSI guidelines). The performance characteristics are reported as the outcome of the tests performed.

Below is a table summarizing the reported device performance for both TP and ALB, drawing from the "Technological Similarities and Differences to the Predicate" section and the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections. Implicit acceptance is typically shown by these results being deemed "safe and effective for their intended uses."

Hitachi S TEST Reagent Cartridge: Reported Device Performance

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

The document describes test sets for various studies:

• Method Comparison (Internal):
  • TP: 115 clinical specimens
  • ALB: 118 clinical specimens
  • Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Described as "clinical specimens."
• Matrices Comparison:
  • TP: 45 matched serum/plasma samples
  • ALB: 41 matched serum/plasma samples
  • Provenance: Not explicitly stated.
• External Site Precision Study:
  • TP: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
  • ALB: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
  • Provenance: "three external POL-type sites," implying clinical settings, likely within the US given the submission to the FDA. Retrospective/prospective not specified for the samples, but the testing itself was prospective within the study timeframe.
• External Method Comparison Studies (POL Accuracy Data Summary):
  • TP: Approximately 50-80 serum specimens per site (n=52, 52, 53). Total around 157.
  • ALB: Approximately 50-80 serum specimens per site (n=87, 81, 81). Total around 249.
  • Provenance: "three external POL-type sites," implying clinical settings, likely within the US. Retrospective/prospective not specified for samples but the comparative testing was prospective.

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

This document describes a diagnostic device for quantitative determination of Total Protein and Albumin. For such devices, "ground truth" is typically established by recognized reference methods, not by expert consensus (e.g., radiologists).

• Method Comparison (Internal and External): The comparison was made against a "standard laboratory system" or "comparative method as the reference method (x)." The specific details of this reference method are not given beyond its use for comparison. No information is provided about human expert involvement in establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic devices like this establish their accuracy against a reference method, not through human adjudication of results.

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

No. This is an in-vitro diagnostic device that provides quantitative measurements. MRMC studies are relevant for imaging devices or those requiring human interpretation.

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

Yes, all studies described (analytical sensitivity, linearity, precision, interference, method comparisons, matrices comparisons) represent the standalone performance of the device (Hitachi Clinical Analyzer E40 with S TEST Reagent Cartridges) in measuring TP and ALB concentrations in samples. These are automated processes without direct human interpretation of results for the purpose of the measurement itself. Human operators are involved in running the analyzer, but the "performance" here refers to the device's analytical capability.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using:

• Reference Methods/Standard Laboratory Systems: For method comparison studies, the device's results (Y) were compared to a "standard laboratory system" or "comparative method" (X). This is a common approach for establishing accuracy of new in-vitro diagnostic devices.
• CLSI Guidelines: Studies like Analytical Sensitivity, Linearity, and Precision followed CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A, EP-6A, EP5-A2). These guidelines define how to determine these performance characteristics, often involving reference materials or established statistical methods for calculation rather than external ground truth.
• Defined Concentrations: For precision and interference studies, samples were used that represented specific (low, middle, high) or known concentrations of the analytes.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device based on chemical reactions and photometric measurements. Its "development" would involve optimizing reagents and calibration, not "training" an algorithm in the AI sense. Therefore, the concept of a training set as understood in AI/ML is not applicable here.

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

As noted in #8, there is no "training set" in the context of AI/ML for this device. The ground truth for developing and calibrating such devices typically relies on:

• Primary Reference Materials: Highly characterized materials with known concentrations of analytes.
• Secondary Reference Materials: Materials traceable to primary reference materials.
• Validated Reference Methods: Established and highly accurate methods, often more complex or expensive, used to assign values to control or calibration materials.

The document implicitly refers to these as part of "assay performance claims were established on the HITACHI Clinical Analyzer."

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In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

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 metabolic or nutritional disorders.

Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.

CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.

The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.

The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.

Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.

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

• Precision:
  • Urine:
    • Within-run: n=21 (Modified device) compared to n=120 (Predicate device).
    • Between-run: n=10 (Modified device).
  • CSF:
    • Within-run: n=20 (Modified device) compared to n=120/119 (Predicate device).
    • Between-run: n=10 (Modified device).
• Method Comparison:
  • Urine samples: n=60 (Modified device vs. Endpoint application). Concentrations between 1.7 and 3286.5 mg/dL.
  • CSF samples: n=50 (Modified device vs. Endpoint application). Concentrations between 5.8 and 110.2 mg/dL.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the study involves comparisons against an existing, cleared device, implying lab-based performance verification. It is implied to be retrospective analysis of performance characteristics, likely from laboratory testing.

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

This type of submission (modification to an in vitro diagnostic test kit) does not typically involve expert review for "ground truth" in the way, for example, an imaging AI device would. The "ground truth" for the performance studies (precision, method comparison) is based on the quantitative results generated by the laboratory instruments themselves, often using reference methods or the predicate device as a comparator. Therefore, this section is not applicable to this type of device.

4. Adjudication Method for the Test Set

As this is a quantitative in vitro diagnostic device, there is no "adjudication method" in the human-centric sense typically applied to image-based AI or complex diagnostic interpretations. The results are numerical values, and their accuracy is assessed against accepted laboratory standards or comparative methods. Therefore, this section is not applicable.

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

This is an in vitro diagnostic device for laboratory use, not an AI device for interpretation by human readers. Therefore, an MRMC study is not applicable.

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

The device itself is a reagent and an application on an automated clinical chemistry analyzer. The performance characteristics reported (precision, method comparison) represent the standalone performance of this "rate application" on the analyzer. The results are quantitative outputs from the instrument. So, in essence, the performance studies reflect the standalone performance of the modified application.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance studies relied on:

• Reference Methods/Predicate Device: For method comparison, the modified rate application was compared against the original endpoint application (which was previously cleared based on comparison with the DuPont ACA method, standardized against NBS Reference Material SRM 927a using the biuret method).
• Known Concentrations: For precision studies, control materials and human samples with referenceable concentrations (though not explicitly stated whether these were clinically confirmed pathology or outcome data) were used. The controls themselves serve as a form of "ground truth" for expected values.

8. The Sample Size for the Training Set

This is a chemical reagent and an application for an automated analyzer, not a machine learning or AI model that requires a "training set" in the typical sense. The original development of the rate application would have involved optimization and testing, but it's not described as a formal "training set" like in AI. Therefore, this section is not applicable for an AI training set, but the development likely involved numerous samples for internal optimization.

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

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the predicate device's original clearance (K913615, which this modification refers back to) was established by standardizing against the National Bureau of Standards Reference Material SRM 927a using the biuret method for protein quantitation. The current submission demonstrates the equivalence of the modified rate application to this established methodology.

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In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders.

Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.

CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems.

C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.

The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid.

Here's a breakdown of the acceptance criteria and study information for the Total Protein Urine/CSF Gen. 3 device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it compares the performance of the modified device (Total Protein Urine/CSF Gen. 3 on COBAS INTEGRA and Roche/Hitachi platforms) against its predicate device (Roche/Hitachi Total Protein Urine/CSF K913615) for various features. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device, meaning the new device performs as well as or better than the predicate for key parameters.

Here's a table summarizing the reported device performance, with the understanding that for most parameters, the 'acceptance' is that the modified device's performance aligns with or improves upon the predicate.

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

The document describes method comparison studies for the COBAS INTEGRA platform against the Roche/Hitachi 917 analyzer.

• Urine Test Set: Sample size (n) = 54
• CSF Test Set: Sample size (n) = 68
• Data Provenance: The text does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "human urine and CSF samples," suggesting clinical samples were used.

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

This information is not provided in the document. The method comparison relies on comparing the device's measurements against a predicate device's measurements, which are assumed to be "ground truth" for the purpose of demonstrating substantial equivalence. There is no mention of independent experts assessing the "accuracy" of the total protein levels.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established by comparison to a predicate device's quantitative measurements, not through subjective expert review and adjudication.

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

No. An MRMC comparative effectiveness study is not relevant for this type of quantitative biochemical assay. This study is about the performance of an automated diagnostic test, not about human readers interpreting images or data.

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

Yes. The entire study describes the standalone performance of the Total Protein Urine/CSF Gen. 3 reagent on automated COBAS INTEGRA systems. This is a fully automated test system, and its performance characteristics (precision, linearity, detection limit, interference) are assessed in a standalone manner without human intervention in the interpretive process. The "human-in-the-loop" aspect would be a laboratory technician operating the instrument and reporting results, but the analytical performance itself is standalone.

7. The Type of Ground Truth Used

The ground truth for the method comparison studies (the primary study described for the modified device) was established by the measurements from the predicate device (Roche/Hitachi 917 analyzer) using the same reagent. The predicate device itself was "Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method for the quantitation of protein." This suggests a chain of traceability to a recognized standard.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an IVD reagent modification submission like this, the focus is typically on validation testing of the final product. Any internal development or training of algorithms (if applicable for such a device, though unlikely for a turbidimetric assay) would be part of the manufacturer's internal design control process and not usually detailed in a 510(k) summary unless explicitly part of the new functionality being validated.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

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The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system.

Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 mm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.

Here's an analysis of the provided text regarding the Abbott Urine/CSF Protein assay, framed by the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a typical quantitative sense (e.g., "correlation coefficient must be > 0.95"). Instead, it states that the new device is "substantially equivalent" to the predicate, and this is demonstrated by the reported performance characteristics. The acceptance is implicitly met if the reported performance is considered "acceptable correlation" and "substantially equivalent" to the predicate.

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

• Sample Size: The document does not explicitly state the exact number of samples used for the method comparison study (the "test set"). It mentions "comparative performance studies" and "precision studies."
• Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected at Abbott Laboratories or a contract research organization working with them. It is a prospective study as it involves conducting new tests to compare the device against a predicate, rather than analyzing existing datasets.

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

This is an in vitro diagnostic (IVD) assay for quantitative protein measurement. The "ground truth" is established by the reference method (the predicate device) or by established analytical techniques. It doesn't involve human expert adjudication in the same way an imaging or pathology device would. Therefore, this question is not directly applicable in a conventional sense for this type of device. The "experts" would be the laboratory personnel performing the assays and analyzing the results according to validated laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD assay where quantitative measurements from one device are compared against another, not a diagnostic interpretation requiring adjudication of reader opinions.

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-assisted diagnostic imaging or pathology system for human readers.

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

Yes, in the context of an IVD, the "standalone" performance refers to the device's analytical performance on its own, which is what the linearity, precision, and sensitivity studies assessed. The method comparison also evaluates the device's performance against a predicate as a standalone system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance studies was:

• Reference Method/Predicate Device: For method comparison, the Boehringer Mannheim® Urinary/CSF Protein assay on the Hitachi® 717 Analyzer served as the reference standard.
• Known Concentrations: For linearity and sensitivity, materials with known concentrations (e.g., calibrators/standards) were used.
• Control Materials: For precision studies, control materials with expected ranges were used.

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning. This is a traditional in vitro diagnostic assay based on a turbidimetric chemical reaction. There isn't a "training set" of data for an algorithm as there would be for an AI/ML device. The "training" of the assay involves optimization of the reagent formulation and reaction conditions, which is a chemical and engineering process, not a data-driven algorithm training.

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

Not applicable. As mentioned, there isn't a "training set" in the AI/ML context. The optimization of the assay's chemical parameters (reagent formulation, reaction conditions) would be based on fundamental chemical principles and empirical experimentation to achieve desired analytical performance characteristics. The "ground truth" for this optimization would be accurate measurements from established analytical methods during development to ensure the new reagent performs as expected.

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The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF). The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 nm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.

Here's a summary of the acceptance criteria and study details for the Urine/CSF Protein assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies.
• The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is implied to be clinical samples since it refers to "human urine or cerebrospinal fluid."

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

• This is not applicable as the study involves a comparative performance analysis against a legally marketed predicate device (Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer), not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is effectively the results obtained from the predicate device.

4. Adjudication Method for the Test Set:

• Not applicable, as this is a performance comparison of an in vitro diagnostic assay against a predicate device, not a study involving expert interpretation or adjudication.

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

• No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an imaging or interpretive device that would typically involve human readers.

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

• Yes, the performance characteristics (method comparison, precision, linearity, sensitivity) are presented as standalone performance of the UPro assay on the AEROSET system. There is no human interaction described in the performance evaluation of the device itself.

7. The Type of Ground Truth Used:

• The "ground truth" for evaluating the UPro assay was established by comparison to a legally marketed predicate device, the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer. The performance of the predicate device serves as the reference standard.

8. The Sample Size for the Training Set:

• The document does not provide information about a training set. As an in vitro diagnostic assay, the "training" would typically refer to the development and optimization of the reagent and assay protocol, rather than a machine learning training set with a specific sample size.

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

• Not applicable in the context of this traditional in vitro diagnostic assay. The ground truth for development and optimization would have been based on established analytical chemistry principles and potentially reference methods, but this type of detail is not typically included in a 510(k) summary.

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