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ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.

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

ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide

The provided document describes the analytical performance of the ELITech Clinical Systems GLUCOSE HK SL reagent, ELICAL 2 calibrator, and ELITROL I/II controls. It does not describe an AI/ML powered device, therefore no information is available regarding expert consensus, MRMC studies, or multi-reader performance. The study described focuses on demonstrating substantial equivalence to predicate devices for in vitro diagnostic use.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria implicitly through the study design (e.g., acceptance bias for interference studies) and generally through comparison to a predicate device. Performance is reported through various analytical studies.

ELITech Clinical Systems GLUCOSE HK SL Reagent Performance Summary:

• Level 1 (45.5 mg/dL): Within-run CV% 1.1, Total CV% 2.0
• Level 2 (119.5 mg/dL): Within-run CV% 0.9, Total CV% 1.7
• Level 3 (251.5 mg/dL): Within-run CV% 0.9, Total CV% 2.0
• Level 4 (522.5 mg/dL): Within-run CV% 0.4, Total CV% 1.8
  Urine:
• Level 1 (18.0 mg/dL): Within-run CV% 0.9, Total CV% 2.0
• Level 2 (204.4 mg/dL): Within-run CV% 0.7, Total CV% 1.7
• Level 3 (497.4 mg/dL): Within-run CV% 0.6, Total CV% 1.7 |
  | Linearity/Assay Range | Serum: Demonstrated linearity for reported range (20 - 720 mg/dL).
  Urine: Demonstrated linearity for reported range (10 - 720 mg/dL). | Serum: Linear range: 20 - 720 mg/dL (y = 1.025x - 2.0 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.0 mg/dL). Auto-dilution to 3600 mg/dL.
  Urine: Linear range: 10 - 720 mg/dL (y = 1.0155x - 1.6 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 3.5 mg/dL). Auto-dilution to 3600 mg/dL. |
  | On-board Stability | 28 days for the reagent. | Reagent: 28 days on-board.
  Shelf-life: 27 months (real-time studies for 36 months). |
  | Limit of Detection (LoD) | Not explicitly stated, but clinical relevance and comparison to predicate device would be implicit. | Serum: 0.3 mg/dL
  Urine: 0.2 mg/dL |
  | Limit of Quantification (LoQ) | Serum: Acceptable Total Error ≤ 0.32 mg/dL; value must be ≥ LoD.
  Urine: Acceptable Total Error ≤ 0.8 mg/dL; value must be ≥ LoD. | Serum: 5.00 mg/dL
  Urine: 5.00 mg/dL |
  | Interference/Analytical Specificity | Accepted bias of ±10% in sample pools with low (50.0 mg/dL for serum, 18.0 mg/dL for urine) or high (120.0 mg/dL for serum, 200.0 mg/dL for urine) nominal activity. Specific interferent concentrations are also listed in the table. | Serum: No significant interference up to listed concentrations for unconjugated bilirubin (30.0 mg/dL), conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), triglycerides (600 mg/dL - note: negative bias observed at higher levels), ascorbic acid (20.0 mg/dL), uric acid (20.0 mg/dL), methyl dopa (2.0 mg/dL), L-dopa (30.0 mg/dL), Tolazamide (50.0 mg/dL), and acetaminophen (30 mg/dL).
  Urine: No significant interference up to listed concentrations for conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), uric acid (100 mg/dL), and urea (6000 mg/dL). No significant interference for pH (2.5 to 12.0) and specific gravity (1.000 to 1.030). |
  | Method Comparison (Correlation) | Demonstrate substantial equivalence to the predicate device (Roche Diagnostics Cobas C111 Glucose HK). | Serum: Against Cobas C111: y = 1.008 x + 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.7 mg/dL.
  Urine: Against Cobas C111: y = 0.996 x - 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 3.5 mg/dL.
  Plasma (Lithium Heparin): y = 1.001x - 0.7 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 1.9 mg/dL.
  Plasma (Sodium Fluoride/Oxalate): y = 1.016x - 0.9 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 7.0 mg/dL. |

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

• Precision Studies:

  • Serum: 80 measurements for each of 4 levels (total of 320 measurements). Samples were human sera and control sera.
  • Urine: 80 measurements for each of 3 levels (total of 240 measurements). Samples were urine pools.
  • Provenance: Not specified, but likely from laboratory samples as part of a method validation. Neither retrospective nor prospective status is explicitly stated, but analytical performance studies are generally conducted prospectively on prepared samples or collected patient samples.

• Linearity Studies:

  • Serum: 11 levels of mixed samples.
  • Urine: 11 levels of mixed samples.
  • Provenance: Not specified, but likely prepared in a laboratory.

• Interference Studies:

  • Serum: Two serum sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations (e.g., 9 for triglycerides, 7 for bilirubin). Each point measured in triplicate per run. Two levels of control materials also tested.
  • Urine: Two urine sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations. Each point measured in triplicate per run. Two levels of control materials also tested.
  • Provenance: Not specified, but laboratory prepared spiked samples.

• Method Comparison Studies (Test Set):

  • Serum: 100 serum patient samples (ranging from 20.5 to 707.5 mg/dL).
  • Urine: 40 urine patient samples (with glacial acetic acid as preservative, ranging from 10.1 to 703.9 mg/dL).
  • Plasma (Lithium Heparin): 40 plasma patient samples (ranging from 24.3 to 710.1 mg/dL).
  • Plasma (Sodium Fluoride/Oxalate): 40 plasma patient samples (ranging from 21.2 to 701.4 mg/dL).
  • Provenance: "patient samples" implies retrospective or prospectively collected clinical samples. The country of origin is not specified but given the submitter's address (France and USA), it could be either.

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

Not applicable, as this is an in-vitro diagnostic test measuring a quantitative analyte (glucose). The "ground truth" for the test set is established by the reference method (Roche Diagnostics Cobas C111 Glucose HK) or known values/concentrations for engineered samples in analytical studies.

4. Adjudication Method for the Test Set:

Not applicable, as this is an in-vitro diagnostic test. Results are quantitative measurements compared against a reference method or known values, not subjective interpretations requiring adjudication.

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

Not applicable, as this is an in-vitro diagnostic test. There is no human reader involvement in interpreting the device's quantitative output.

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

Yes, the studies described are all "standalone" in the sense that they evaluate the analytical performance of the device (reagent, calibrator, controls) on an automated analyzer (ELITech Clinical Systems Selectra ProM Analyzer) without human intervention in the result determination process.

7. The Type of Ground Truth Used:

• Known concentrations: For linearity, LoD/LoQ, and interference studies, samples were prepared to have known or target concentrations of glucose and interferents.
• Reference method/device: For method comparison studies, the predicate device (Roche Diagnostics Cobas C111 Glucose HK) was used as the comparative "ground truth" for patient samples.
• NIST Traceability: For calibration, the glucose value assigned to the calibrator (ELICAL 2) is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML powered device, so there is no "training set." The device performance is based on the chemical reagent's properties and the analyzer's measurement capabilities.

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

Not applicable (no training set).

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ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

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

The provided text describes information about the ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I & II (control sera), specifically for the addition of new constituents (IRON FERENE and MAGNESIUM XYLIDYL). It focuses on demonstrating substantial equivalence to predicate devices rather than independent clinical performance studies for complex AI/ML devices. Therefore, much of the requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or not present in this document.

However, I can extract the acceptance criteria and performance related to the stability and value assignment for these in vitro diagnostic devices. The studies conducted are primarily focused on demonstrating the equivalency of the new lots/constituents to the existing product and predicate devices, and ensuring appropriate stability and accurate value assignment.

Here's an attempt to structure the available information according to your request, with explicit notes about what information is not present:

Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria and testing for ELITech Clinical Systems ELICAL 2 (calibrator) and ELITech Clinical Systems ELITROL I & II (control sera). The primary performance parameters evaluated are stability and value assignment. The study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

• 15-25°C: 8 hours
• 2-8°C: 2 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 3 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 6 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) | Lyophilized: Stable at 2-8°C until expiration date.
  After Reconstitution:
• 15-25°C: 12 hours
• 2-8°C: 5 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 4 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 8 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) |
  | Reported Performance (Stability) | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. |
  | Acceptance Criteria (Value Assignment) | For ELICAL 2: The mean analyte value is calculated based on measurements against appropriate standard reference material. Verification is performed by calibrating with new lot's assigned values and measuring quality control material at two levels, verifying that obtained values are within the labeled range of the quality control. | For ELITROL I & II: Target value for Level I and II is the median of the observed values range. A confidence range (high and low values) is calculated after validation of the target value. The expectation is that the controls perform as expected within these ranges. |
  | Reported Performance (Value Assignment) | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent QC measurements were within acceptance. | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent confidence ranges were within acceptance. |
  | Substantial Equivalence | Demonstrated by comparison to predicate device K033501 (Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s)) showing similarities in intended use, format, level, handling, traceability, and stability. | Demonstrated by comparison to predicate device K041127 (Roche Diagnostics Precinorm U & Precipath U) showing similarities in intended use, format, levels, handling, and stability. |

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

• ELICAL 2 (Calibrator):
  • For Value Assignment: "a target value is assigned on a minimum of 48 measurements taken." This is the number of measurements used to establish the value for each analyte.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics (a global company). The data is presented as prospective testing of new lots/constituents to establish their values and stability.
• ELITROL I & II (Control Sera):
  • For Value Assignment: "Each sample is tested in triplicate over several days using two separate ELITech Clinical Systems Selectra analyzers." A specific total number of measurements is not provided, but it implies multiple triplicate measurements.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics. The data is presented as prospective testing of new lots/constituents to establish their values and stability.

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

• Not Applicable. This is an in vitro diagnostic device for calibrators and control sera. The "ground truth" for these types of devices is established through analytical methods and reference materials, not expert consensus (e.g., radiologists interpreting images). The values are determined by analytical measurement against appropriate standards.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is established by analytical methods and reference materials, there is no expert adjudication process involved. The results are quantitative measurements compared against established standards or internal criteria.
  • For ELICAL 2, value assignment verification involved checking if measurements of quality control material fell within a labeled range.
  • For ELITROL I & II, the target value was the median of observed values, and a confidence range was calculated, indicating an analytical determination rather than adjudication.

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

• Not Applicable. This document describes in vitro diagnostic calibrators and control sera, not AI-powered image analysis or diagnostic systems that involve human readers.

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

• Not Applicable. This document describes in vitro diagnostic calibrators and control sera. These devices are reagents used in automated analytical instruments (Selectra Pro Series Analyzers), and their performance is inherent to the chemical properties and manufacturing process, not an algorithm. The "performance" is how accurately and reproducibly they can be used to calibrate and control other assays, which is assessed analytically.

7. The type of ground truth used:

• Analytical Standards/Reference Materials & Internal Consistency:
  • For ELICAL 2 (Calibrator): The ground truth for value assignment is established by testing against "appropriate standard reference material" on two separate analyzers. This means the values are traced to known, highly accurate reference standards.
  • For ELITROL I & II (Control Sera): The "target value" is determined as "the median of the observed values range" from multiple measurements on two analyzers. This indicates an internal analytical consensus approach based on repetitive testing and statistical methods to establish the expected control range.

8. The sample size for the training set:

• Not Applicable / Not provided. These are in vitro diagnostic reagents, not AI/ML algorithms that require training sets in the computational sense. The document describes processes for establishing performance characteristics of a manufactured product (calibrators and control sera).

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

• Not Applicable. (See point 8).

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

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

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.

The provided text describes the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.

The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.

Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:

1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):

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

• Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
• Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents" and then measuring the amount of lipase in the "new lots of ELITROL I and ELITROL II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
• Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.

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

• Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.

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 not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.

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

• Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.

7. The type of ground truth used:

• For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.

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

• Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.

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ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

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

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid, Hydrochloric acid and cetrimide. Reagent R2 contains sodium nitrite.

ELITech Clinical Systems BILIRUBIN DIRECT 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid and Hydrochloric acid. Reagent R2 contains sodium nitrite.

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, outlining the acceptance criteria and study details for the ELITech Clinical Systems Bilirubin devices.

Important Note: The provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, independent study seeking to establish the device's absolute performance against a
predefined, absolute acceptance criteria. The "acceptance criteria" in this context refer to the performance benchmarks the new device needs to meet to be considered "substantially equivalent" to an already cleared device, typically by showing similar or better performance in key metrics. The study described is a comparison study against the predicate, not a study to prove meeting absolute acceptance criteria in the same way a de novo or PMA device would.

Acceptance Criteria and Device Performance for ELITech Clinical Systems BILIRUBIN TOTAL 4+1

1. Table of Acceptance Criteria and Reported Device Performance

Study Details for ELITech Clinical Systems BILIRUBIN TOTAL 4+1

The information provided is a 510(k) Summary, which typically presents a comparison between a new device and a legally marketed predicate device to establish "substantial equivalence." It doesn't detail a standalone study with pre-defined, absolute acceptance criteria in the same way a full clinical trial would. Instead, the "study" is a series of in-vitro analytical performance tests comparing the new device against the predicate.

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

• Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison or interference studies. For precision, specific levels are tested, but the number of replicates/runs is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in-vitro diagnostic, the samples would likely be human serum and plasma, possibly from a clinical lab setting.

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

• This is an in-vitro diagnostic device for quantitative measurement. The "ground truth" for the test set is established by the measurements obtained from the predicate device (ABX PENTRA BILIRUBIN, TOTAL CP) and potentially reference methods or characterized materials for analytical performance studies (e.g., linearity, LoD, LoQ).
• No human experts (e.g., radiologists, pathologists) are explicitly mentioned as establishing ground truth in this context, as the output is a quantitative biochemical measurement, not an interpretive one.

4. Adjudication Method for the Test Set

• Not applicable as this is an analytical performance study comparing quantitative measurements, not an interpretive study requiring adjudication of expert opinions.

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

• No, a MRMC study was not done. This type of study is relevant for interpretive tasks where human readers (e.g., radiologists) provide diagnoses, and AI assistance is evaluated. This device is an automated in-vitro diagnostic assay.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Yes, the performance metrics reported (Measuring range, LoD, LoQ, Precision, Method Comparison, Limitations) are for the standalone algorithm/device as an automated assay. There is no human intervention in the measurement process other than preparing samples and operating the analyzer.

7. Type of Ground Truth Used

• The "ground truth" for comparative purposes against the predicate device is implied to be the measurements obtained from the predicate device itself for method comparison studies. For other analytical performance elements (LoD, LoQ, precision), validated reference materials or spiked samples are typically used.

8. Sample Size for the Training Set

• The document does not specify a "training set" size. This is an analytical device where performance is characterized rather than a machine learning algorithm that is "trained" on a dataset in the conventional sense. The device's components (reagents, analyzer settings) are developed and optimized, but the concept of a "training set" as used in AI/ML is not directly applicable here.

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

• Not applicable, as there's no conventional "training set" for a machine learning algorithm. The development and optimization of the reagent formulation and instrument parameters would be based on established chemical and analytical principles and potentially internal validation studies with characterized samples.

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

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

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.

The provided text describes two in vitro diagnostic devices, ELICAL 2 (a calibrator) and ELITROL I / ELITROL II (controls), and their comparison to predicate devices for 510(k) clearance.

However, the documentation provided does not contain information related to an AI/ML-based device. It describes traditional in vitro diagnostic devices, specifically a multi-analyte calibrator and multi-analyte controls based on human serum.

Therefore, I cannot provide an answer that includes details typical of an AI/ML device study, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or a table of acceptance criteria and reported device performance for an AI/ML model.

The document focuses on demonstrating substantial equivalence of the new calibrator and control devices to existing predicate devices based on attributes like intended use, format, levels, handling, traceability, and stability. The "performance data" mentioned in the Conclusion likely refers to the analytical performance characteristics (e.g., stability) that were tested to show the new devices perform comparably to the predicates, rather than the performance of an AI algorithm.

To answer your request thoroughly, I need information about an AI/ML device study. The current document does not provide the necessary details.

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ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. 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).

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.

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.

The provided text describes several in-vitro diagnostic devices (reagents, calibrators, and controls) and their performance characteristics. However, it does not contain information about studies involving AI, human readers, or image analysis. The data provided is for traditional laboratory assays, comparing a new device to a predicate device.

Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, such as:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not specified for clinical samples in the context of an AI study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable for chemical assays.
• Adjudication method - Not applicable for chemical assays.
• 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 AI component described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - No AI component described.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not explicitly stated in terms of expert consensus or pathology for clinical samples, but implied to be analytical results from established methods.
• The sample size for the training set - No AI component described, so no training set discussed.
• How the ground truth for the training set was established - No AI component described.

Below is an attempt to address the request based only on the information available in the provided text, primarily focusing on the "ELITech Clinical Systems CALCIUM ARSENAZO" reagent as it is the first device detailed.

Acceptance Criteria and Device Performance Study for ELITech Clinical Systems CALCIUM ARSENAZO

The provided document describes the performance characteristics of the ELITech Clinical Systems CALCIUM ARSENAZO reagent, a quantitative in vitro diagnostic device for total calcium in human serum and plasma. The study presented is a comparison to a legally marketed predicate device, Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, where the new device's performance metrics are expected to be comparable or better. The table below summarizes the reported performance of the ELITech Clinical Systems CALCIUM ARSENAZO. Specific numerical acceptance criteria (e.g., "must be ≥X") are not explicitly stated as separate targets, but rather demonstrated through direct comparison to the predicate's known performance or through established analytical performance ranges.

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

The document does not explicitly state the specific sample size for the clinical test set used in method comparison or interference studies. It is described as testing human serum and plasma.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary.

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

Not applicable. This is a chemical assay, not an assessment requiring expert interpretation of images or clinical findings. The "ground truth" for the test set would be established by the predicate device's accepted analytical results, or other reference methods for analytical performance studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human adjudication of clinical findings.

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 document describes an in vitro diagnostic reagent; there is no AI component or human reader study involved.

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

Not applicable. This document describes an in vitro diagnostic reagent; there is no algorithm or AI component. The "standalone" performance here refers to the analytical performance of the reagent on the specified analyzer.

7. The Type of Ground Truth Used

For method comparison, the ground truth is established by comparing the results of the ELITech Clinical Systems CALCIUM ARSENAZO with analyses performed using the predicate device (Stanbio Calcium LiquiColor®) on the same samples. For precision, linearity, and interference studies, ground truth would be based on known concentrations or preparations in control materials and spiked samples. This is a form of analytical ground truth.

8. The Sample Size for the Training Set

Not applicable. There is no AI component, and thus no "training set" in the context of machine learning.

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

Not applicable as there is no training set for an AI model. For the analytical studies, ground truth is established through standard laboratory practices for calibrators, controls, and comparative methods.

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ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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

ELITech Clinical Systems ELITROL I is a multi-parametric 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 multi-parametric 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.

ELITech Clinical Systems GLUCOSE PAP SL is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.

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.

The provided text describes three medical devices seeking 510(k) clearance: ELITech Clinical Systems GLUCOSE PAP SL reagent, ELITech Clinical Systems ELICAL 2 calibrator, and ELITech Clinical Systems ELITROL I and ELITROL II controls. The submissions focus on demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study data presented for each device, structured according to your requested information:

1. ELITech Clinical Systems GLUCOSE PAP SL reagent

This device is a glucose reagent used for quantitative determination of glucose in human serum and plasma. The submission compares its performance to the ABX PENTRA GLUCOSE PAP CP predicate device.

• 1. A table of acceptance criteria and the reported device performance

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