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510(k) Data Aggregation
(131 days)
JFY
The Atellica® CH Enzymatic Creatinine 3 (ECre3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin and dipotassium EDTA), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The Atellica CH ECre3 assay measures the concentration of creatinine through a series of coupled enzymatic reactions and is based upon the method developed by Masaru and Mitsutaka. The Atellica CH ECre3 assay uses a series of coupled enzymatic reactions. In a "pretreatment" reaction, endogenous creatine and sarcosine are removed from a test sample by creatinase and sarcosine oxidase. The level of creatinine in a test sample is then determined through coupled enzymatic reactions. First, creatinine is enzymatically converted by creatininase into creatine. Creatine is then enzymatically converted to sarcosine by creatinase. This is followed by the oxidation of sarcosine by sarcosine oxidase to produce hydrogen peroxide. In the presence of peroxidase, the hydrogen peroxide allows for the oxidative condensation of 4-aminoantipyrine and N-ethyl-N-(3-methylphenyl)-N'-succinyl-ethylenediamine to produce a reddish purple quinone pigment. The absorbance of this quinone pigment is measured as an endpoint reaction at 545/694 nm.
This document describes the performance of the Atellica® CH Enzymatic Creatinine 3 (ECre3) assay, a new in vitro diagnostic device for quantitative determination of creatinine. The information provided is for a 510(k) Premarket Notification to the FDA, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" here refers to the performance thresholds that the new device must meet to show it functions as intended and is comparable to the predicate device. The "study" refers to the analytical performance validation studies conducted.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Sizes and Data Provenance
Since this is an in vitro diagnostic (IVD) device, the "acceptance criteria" are typically defined as performance specifications that demonstrate the device's analytical accuracy, precision, linearity, and freedom from interferences. These are not clinical acceptance criteria in the sense of diagnostic accuracy to a specific disease state, but rather analytical performance metrics. The document compares the new device (candidate) to a predicate device and established standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Target/Goal) | Reported Device Performance (Achieved) | Sample Size for Test Set (and Provenance) |
|---|---|---|---|
| Detection Capability | LoQ: ≤ 0.15 mg/dL (serum/plasma), ≤ 2.00 mg/dL (urine) - (Lowest concentration at which total analytical error is ≤ 0.10 mg/dL for serum/plasma and ≤ 1.50 mg/dL for urine) | LoB: Serum/plasma: 0.05 mg/dL; Urine: 0.15 mg/dL | |
| LoD: Serum/plasma: 0.10 mg/dL; Urine: 0.50 mg/dL | |||
| LoQ: Serum/plasma: 0.15 mg/dL; Urine: 2.00 mg/dL | |||
| (Meets or exceeds design specifications for LoQ) | Not explicitly stated as a "sample size" for detection capability tests in terms of unique patient samples, but the methodology (CLSI Document EP17-A2) typically involves repeated measurements of blank, low-concentration, and spiked samples. Provenance is not specified for these control samples or blanks. | ||
| Precision | Not explicitly stated as a single numerical acceptance criterion (e.g., CV X), but expected to demonstrate strong correlation between plasma types and serum. Evaluated against CLSI EP09c. | Lithium heparin plasma vs. Serum: y = 0.99x + 0.00 mg/dL; r = 1.000 | |
| Dipotassium EDTA plasma vs. Serum: y = 0.97x + 0.02 mg/dL; r = 0.998 | |||
| (Demonstrates strong equivalency) | For each comparison (Lithium heparin plasma vs. Serum, Dipotassium EDTA plasma vs. Serum): 55 samples. Provenance of these patient samples is not specified. Implied human patient samples. | ||
| Interferences (HIL) | ≤ 10% bias from hemoglobin, bilirubin, and lipemia. Bias > 10% is considered interference. | Hemoglobin: -3.2% to 6.0% (at tested concentrations) | |
| Bilirubin (conjugated & unconjugated): -1.6% to -6.2% (at tested concentrations) | |||
| Lipemia (Intralipid®): -2.6% to -3.8% (at tested concentrations) | |||
| (All tested HIL substances show ≤ 10% bias, meeting the criterion) | Not explicitly stated as "sample size" for this study. Interference testing typically involves preparing samples with known analyte concentrations and varying concentrations of interferents. Provenance of samples is not specified, likely control or pooled samples spiked with interferents. | ||
| Non-Interfering Substances | ≤ 10% bias at specific analyte concentrations (1.00 mg/dL and 8.00 mg/dL for serum; 40.00 mg/dL and 180.00 mg/dL for urine). | Various common substances (e.g., Acetaminophen, Cefoxitin, Glucose) tested showed biases generally well within the ±10% range. Phenindione is an exception, with a warning against its use due to reported falsely depressed results. | |
| (Generally meets criteria, with a clinically relevant exception noted) | Not explicitly stated as "sample size". Similar to HIL, involves preparation of spiked samples. Provenance of samples is not specified. | ||
| Linearity | Demonstrate linearity for the measuring interval from 0.15-30.00 mg/dL (serum/plasma) and 2.00–245.00 mg/dL (urine). | Achieved: Linear from 0.15-30.00 mg/dL for Serum/plasma and from 2.00–245.00 mg/dL for Urine. | |
| (Meets the specified measuring interval) | Not explicitly stated as "sample size". Linearity studies (CLSI EP06-A) typically involve preparing and testing several dilutions of high-concentration samples. Provenance is not specified. |
Data Provenance (General): The document does not explicitly state the country of origin for the patient samples used in method comparison or specimen equivalency studies. It also does not specify if the studies were retrospective or prospective, though for IVD analytical performance, they are typically prospective analytical studies using characterized samples (pooled, spiked, or real patient samples collected for the study).
Regarding items 3-9 for this IVD document:
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For an IVD device like this, "ground truth" for analytical performance studies is established by reference methods (e.g., Isotope Dilution Mass Spectrometry - IDMS, as seen in the assay comparison) or against a legally marketed predicate device (ADVIA Chemistry ECRE_2 assay). It is not established by human experts (like radiologists reading images) for diagnostic accuracy or consensus in the typical sense for medical imaging or clinical decision support AI. The "experts" would be the metrologists or lab professionals validating the reference methods according to CLSI guidelines.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of an IVD analytical performance study. Adjudication methods are relevant for subjective interpretations, like radiology image reads or pathological diagnoses, where human variability exists and a consensus "ground truth" needs to be established. Here, the "truth" is quantitative measurement by reference methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (often involving human readers and AI) where subjectivity and reader variability are factors. This submission is for an in vitro diagnostic assay, which provides quantitative values, not an imaging-based AI or a system that aids human interpretation in a subjective setting.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is inherently a "standalone" device in the sense that it is an automated laboratory assay. Its performance is measured directly (algorithm only) against reference methods or the predicate, as presented in the analytical performance section. There isn't a "human-in-the-loop" component in its operation or interpretation beyond the lab professional running the analyzer and reviewing results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance evaluation is established by:
- Reference Methods: Specifically, Isotope Dilution Mass Spectrometry (IDMS) for creatinine measurements, which is a highly accurate and precise chromatographic-mass spectrometric method. This is considered the "gold standard" for creatinine measurement.
- Comparison to a Legally Marketed Predicate Device: The ADVIA® Chemistry Enzymatic Creatinine_2 (ECRE_2) assay. The performance against the predicate is used to demonstrate "substantial equivalence."
- Internal analytical validation: Using controlled samples (e.g., spiked samples, control materials) for precision, linearity, interference studies, where the "ground truth" is the known concentration or expected behavior of the sample.
8. The sample size for the training set:
- This document describes the validation of the device's performance, not its development or "training." For an IVD assay (like a chemical reagent and analyzer system), there isn't a "training set" in the machine learning sense. The assay is based on established enzymatic reaction principles, not on learned patterns from a "training set" of data. Therefore, this concept is not applicable here.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of IVD device. The assay's chemical reactions and measurement principles are intrinsically defined, not learned from data.
Ask a specific question about this device
(497 days)
JFY
Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction.
The Horiba ABX SAS Yumizen C1200 Creatinine PAP device is an in vitro diagnostic intended for the quantitative determination of Creatinine in human serum, plasma, and urine. Its performance was evaluated through various analytical studies to demonstrate substantial equivalence to its predicate device, the ABX Pentra Enzymatic Creatinine CP.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from "within specifications") | Reported Device Performance (Yumizen C1200 Creatinine PAP) |
|---|---|---|
| Measuring Range | ||
| Serum Limit of Quantitation | Not explicitly stated, but implies the lowest concentration measurable with acceptable precision. | 0.11 mg/dL |
| Serum Linearity | Not explicitly stated, but implies correlation across range. | 0.04 - 19.93 mg/dL |
| Serum Measuring Range | Not explicitly stated, but likely the linear range with acceptable bias. | 0.11 - 16.95 mg/dL (up to 50.85 mg/dL with post-dilution) |
| Urine Limit of Quantitation | Not explicitly stated, but implies the lowest concentration measurable with acceptable precision. | 1.13 mg/dL |
| Urine Linearity | Not explicitly stated, but implies correlation across range. | 0.00 - 327.60 mg/dL |
| Urine Measuring Range | Not explicitly stated, but likely the linear range with acceptable bias. | 3.56 - 175 mg/dL (up to 525 mg/dL with post-dilution) |
| Accuracy and Precision (Instrument Variability - Serum/Plasma) | ||
| Within-run CV (low level) | ≤ 4.5 % | 0.5% (Yumizen N Multi Control), 1.4% (Sample 1) |
| Within-run CV (middle level) | ≤ 3.4 % | 0.3% (Yumizen P Multi Control), 0.5% (Sample 2) |
| Within-run CV (high level) | ≤ 1.8 % | 0.3% (Sample 3) |
| Total CV (low level) | ≤ 6.0 % | 1.5% (Yumizen N Multi Control), 2.9% (Sample 1) |
| Total CV (middle level) | ≤ 4.5 % | 1.3% (Yumizen P Multi Control), 2.0% (Sample 2) |
| Total CV (high level) | ≤ 2.4 % | 1.3% (Sample 3) |
| Accuracy and Precision (Lot to Lot Variability - Serum/Plasma) | ||
| Within-run CV (low level) | ≤ 4.5 % | Not reported separately, but "Within-Day (%CV)" for Sample 1 (1.7%) is shown |
| Within-run CV (middle level) | ≤ 3.4 % | Not reported separately, but "Within-Day (%CV)" for Sample 2 (0.9%) is shown |
| Within-run CV (high level) | ≤ 1.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 4 (0.4%) is shown |
| Total CV (low level) | ≤ 6.0 % | 4.6% (Sample 1) |
| Total CV (middle level) | ≤ 4.5 % | 2.0% (Sample 2) |
| Total CV (high level) | ≤ 2.4 % | 0.5% (Sample 4) |
| Accuracy and Precision (Instrument Variability - Urine) | ||
| Within-run CV (low level) | ≤ 4.5 % | 1.2% (Sample 1) |
| Within-run CV (middle level) | ≤ 3.8 % | 0.8% (Sample 2) |
| Within-run CV (high level) | ≤ 3.8 % | 0.8% (Sample 3) |
| Total CV (low level) | ≤ 6.0 % | 4.2% (Sample 1) |
| Total CV (middle level) | ≤ 5.0 % | 4.3% (Sample 2) |
| Total CV (high level) | ≤ 5.0 % | 3.9% (Sample 3) |
| Accuracy and Precision (Lot to Lot Variability - Urine) | ||
| Within-run CV (low level) | ≤ 4.5 % | Not reported separately, but "Within-Day (%CV)" for Sample 1 (1.1%) is shown |
| Within-run CV (middle level) | ≤ 3.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 2 (0.9%) is shown |
| Within-run CV (high level) | ≤ 3.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 3 (0.9%) is shown |
| Total CV (low level) | ≤ 6.0 % | 2.1% (Sample 1) |
| Total CV (middle level) | ≤ 5.0 % | 1.3% (Sample 2) |
| Total CV (high level) | ≤ 5.0 % | 0.9% (Sample 3) |
| Interferences (Serum/Plasma) | Acceptable bias +/-10% of the value without interfering substances. | All listed interferents (Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen, N-Acetylcystein, Glucose, Total Protein, Methyldopa, L-Dopa, Calcium Dobesilate) showed no interference higher than +/-10% at the specified concentrations. |
| Interferences (Urine) | Acceptable bias +/-10% of the value without interfering substances. | All listed interferents (Hemoglobin, Triglycerides, Direct Bilirubin, Ascorbic acid, N-Acetylcystein, pH) showed no interference higher than +/-10% at the specified concentrations. |
| Matrix Comparison (Serum/Lithium Heparin Plasma) | No significant difference between serum and plasma with heparin specimens. | Regression line: Intercept = -0.0281, Slope = 1.0008, r² = 0.995. This indicates no significant difference. |
| Method Comparison (Serum/Plasma vs. Predicate) | High correlation and acceptable agreement (implied by CLSI EP-9A3). | Regression line (Passing Bablok): Intercept = -0.0107, Slope = 0.9611, r² = 0.997. |
| Method Comparison (Urine vs. Predicate) | High correlation and acceptable agreement (implied by CLSI EP-9A3). | Regression line (Passing Bablok): Intercept = 0.2296, Slope = 0.9772, r² = 0.994. |
| Reagent Stability (Closed) | Stable up to expiry date. | 12 months (at 2-8°C). |
| Reagent Stability (Open, On-Board) | Stable for a specified period. | 6 weeks. |
| Reference Range Verification (Serum/Plasma - Men) | Consistent with established literature reference ranges. | Normal range: 0.67 - 1.17 mg/dL (consistent with Mazzachi et al. reference). |
| Reference Range Verification (Serum/Plasma - Women) | Consistent with established literature reference ranges. | Normal range: 0.51 - 0.95 mg/dL (consistent with Mazzachi et al. reference). |
2. Sample sizes used for the test set and the data provenance
- Measuring Range:
- Limit of detection and quantitation: Determined according to CLSI guideline EP17-A2. (Specific sample size not provided in the summary but typically involves multiple replicates of low-concentration samples).
- Linearity: Determined according to CLSI guideline EP06-A. (Specific sample size not provided in the summary but involves multiple concentrations with replicates).
- Accuracy and Precision:
- Instrument Variability (Serum/Plasma & Urine): 240 measurements (20x2x2 means 20 replicates for each of 3 samples, on 2 runs for 2 instruments over a certain period - or 20 days x 2 runs/day x 2 instruments). The samples were control materials and native samples.
- Lot-to-Lot Variability (Serum/Plasma & Urine): 90 measurements (3x5x2x3 implies 3 lots, 5 days, 2 runs/day, 3 samples). The samples were control materials and native samples.
- Interferences: Not explicitly stated, but typically involves testing known concentrations of interferents in base samples.
- Matrix Comparison: 84 paired samples (serum and lithium heparin plasma) from single donors.
- Method Comparison:
- Serum/Plasma: 103 native human serum samples. Data provenance: collected from CHU Nîmes (University Hospital Center). Retrospective (remnants).
- Urine: 129 native human urine samples. Data provenance: collected from routine clinical laboratory. Retrospective (remnants).
- Reagent Stability: Determined according to CLSI guideline EP25-A. (Specific sample size not provided).
- Reference Range Verification:
- Serum/Plasma - Men: 45 "normal samples" from a blood bank.
- Serum/Plasma - Women: 41 "normal samples" from a blood bank.
- Children & Urine: Verification could not be made due to lack of availability of samples from healthy pediatric patients/healthy people.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for this device, which is a quantitative in vitro diagnostic for creatinine levels. For such devices, ground truth is typically established by:
- A reference method (e.g., mass spectrometry) for accuracy studies.
- The established values of control materials.
- The results from a legally marketed predicate device (as seen in method comparison).
- Literature values for reference range verification.
4. Adjudication method for the test set
Not applicable. This is a quantitative diagnostic device, not one requiring 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 a quantitative diagnostic device, not an AI-assisted diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a standalone in vitro diagnostic device (reagent and instrument system). Its performance described above (e.g., precision, accuracy, linearity, interference) represents the algorithm-only (device-only) performance, without human interpretation of the result influencing the quantitative output.
7. The type of ground truth used
- Measuring Range, Accuracy, Precision, Interferences, Reagent Stability: Internal specifications, established reference materials (controls), and recognized scientific methods (e.g., spiked samples for linearity and interference).
- Matrix Comparison: Paired samples from the same donor, with comparison between results from serum and plasma. The expectation is that the creatinine value should be the same across matrices for the same individual.
- Method Comparison: The predicate device's results (ABX Pentra Enzymatic Creatinine CP) served as the reference for comparison using method comparison studies (Passing Bablok regression).
- Reference Range Verification: Reference ranges cited in scientific literature (e.g., Mazzachi BC et al., Schlebusch Soldin SJ et al., Roberts WL et al.) were used for verification against measured values in "normal" samples.
8. The sample size for the training set
The document describes performance evaluation studies (validation) rather than a clear "training set" for an algorithm. For a device like this, the "training" usually refers to the development and optimization of the reagent formulation and instrument parameters. The specific sample sizes used for this developmental phase are not detailed in the summary. The provided sample sizes are for the analytical performance studies which are typically considered validation.
9. How the ground truth for the training set was established
As there isn't a "training set" in the context of machine learning, this question isn't directly applicable. For the development of an IVD like this, ground truth would be established during the R&D phase through:
- Using purified creatinine standards.
- Comparison with established and highly accurate reference methods (e.g., isotope dilution mass spectrometry, IDMS).
- Clinical samples with results from well-characterized, clinically accepted methods.
Ask a specific question about this device
(329 days)
JFY
The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.
The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The device is provided as a kit that is comprised of a canister of 100 FDA-cleared urine test strips (ACON Laboratories Inc. Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) K150330), 10 Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend. The software component of the ACR | LAB consists of both an application (App) and a Backend server (Backend). The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification. Once analyzed, the results are securely transmitted to a patient Electronic Medical Record for review by a healthcare professional. The patients do not have access to the results at any point during the testing process.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria are based on the agreement between the ACR | LAB Urine Analysis Test System and the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The study aimed for high percentages of exact match and ±1 color block match.
| Metric (Agreement with Predicate Device) | Acceptance Criteria (Implicit from "high levels of accuracy") | Reported Device Performance (ACR | LAB) |
| :--------------------------------------- | :----------------------------------------------------------- | :-------------------------------------- |
| Albumin | High Exact Match % | 89% Exact Match |
| Albumin | High ±1 Color Block Match % | 100% ±1 Color Block Match |
| Creatinine | High Exact Match % | 84% Exact Match |
| Creatinine | High ±1 Color Block Match % | 100% ±1 Color Block Match |
| Albumin-Creatinine Ratio | High Exact Match % | 93% Exact Match |
| Albumin-Creatinine Ratio | High ±1 Color Block Match % | 100% ±1 Color Block Match |
Note: The document explicitly states that the primary acceptance criteria for the method comparison study were the percent of exact match and ±1 color block match. While specific numerical targets for "high levels of accuracy" are not given as explicit "acceptance criteria," the reported performance exceeding predicate device agreement in these metrics is implicit evidence of meeting those criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Native Urine Samples: 375 subjects
- Contrived Samples: 60 samples
- Total Samples for Clinical Performance: 435 samples (375 native + 60 contrived)
- Data Provenance: The study evaluated native urine samples from 375 subjects as well as 60 contrived samples at three U.S. clinical sites. This indicates the data is prospective (newly collected for the study) and from the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer) as the "ground truth" or reference for comparison.
- Number of "Experts" (for ground truth): The ground truth was established by readings from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Two separate lab technicians measured each urine sample, one using the iPhone 7 device (ACR | LAB) and the second using the predicate device (U120 Ultra).
- Qualifications of "Experts": The document states "Two separate lab technicians were responsible for measuring each urine sample." Their specific qualifications (e.g., years of experience, certifications) are not explicitly mentioned, but they are identified as "lab technicians."
4. Adjudication Method for the Test Set
The adjudication method appears to be none in the traditional sense of multiple human experts reviewing and deciding. Instead, the study directly compared the results of the ACR | LAB device against the results obtained from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Each sample was tested once by the ACR | LAB and once by the predicate device, and the agreement between these two measurements was assessed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
- Was an MRMC study done? No, a traditional MRMC comparative effectiveness study was not done. This study is focused on the performance of a clinical diagnostic device, where consistency with a reference device is key, rather than an AI-assisted interpretation by multiple human readers.
- Effect size of human readers improve with AI vs without AI assistance: This information is not applicable/not provided, as the study design was a direct comparison of the new device to a predicate device, not an assessment of human reader performance with and without AI assistance. The ACR | LAB system itself includes the smartphone app and image recognition algorithm as central components of its operation, so human interaction is inherent, but not a separate "with vs. without AI assistance" arm for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device description indicates that the "ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips." It also mentions that "The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification."
This suggests that the device does not operate purely standalone (algorithm-only without human-in-the-loop). A healthcare professional is involved in:
* Performing the physical test (dipping the strip).
* Operating the smartphone application.
* Placing the strip on the Color-Board for scanning.
The algorithm on the Backend performs the complete analysis and classification, but this is initiated and guided by the human user through the app. Therefore, it's a human-in-the-loop system, and no standalone algorithm-only performance is documented separately.
7. The Type of Ground Truth Used
The ground truth for the clinical performance study was established by comparison to a legally marketed predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The aim was to demonstrate substantial equivalence, meaning the new device's results should align closely with those of the established predicate.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set for the image recognition algorithm. It focuses on the validation studies.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It broadly mentions the software validation and hazard analysis but doesn't detail the data labeling process for the algorithm's training. It is common for such systems to be trained on a large dataset of images with corresponding known (e.g., laboratory-confirmed) values for albumin and creatinine, but this specific information is not provided here.
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(58 days)
JFY
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.
- · Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
- · Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
- · Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Creatinine, BUN and tCO₂. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).
Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.
Here's a breakdown of the acceptance criteria and study information for the GEM Premier ChemSTAT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates that "All results were within specification" and successful performance in comparison to predicate devices. For this summary, I've inferred the performance metrics as the reported study outcomes.
| Analyte | Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Creatinine (Crea) | Internal Precision (Total %CV) | Within specification (not explicitly stated, but |
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(133 days)
JFY
The URiSCAN 10 ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results.
The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.
The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.
The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.
The provided document is an FDA 510(k) clearance letter for the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer. It outlines the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed study information regarding acceptance criteria and performance data requested in your prompt.
The 510(k) summary (which is typically available in a separate document for device clearances) would contain the performance data and a summary of the studies conducted to demonstrate substantial equivalence. The provided text is solely the clearance letter itself.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not in the provided text.
- Sample sizes used for the test set and the data provenance: Not in the provided text.
- Number of experts used to establish the ground truth and their qualifications: Not in the provided text.
- Adjudication method: Not in the provided text.
- MRMC comparative effectiveness study details: Not in the provided text.
- Standalone performance details: Not in the provided text.
- Type of ground truth used: Not in the provided text.
- Training set sample size: Not in the provided text.
- How ground truth for the training set was established: Not in the provided text.
The closest relevant information in the provided text is the "Indications for Use" section (Page 2), which describes what the device is intended to measure and for what purpose, but it does not include performance data or study methodology.
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- VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
- VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
- VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
- VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.
The VITROS XT 7600 Integrated System is a fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The System operates in conjunction with reagents, calibrators and controls designed for use with the System in the MicroSlide, MicroTip or MicroWell format.
The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, and VITROS Chemistry Products TBIL Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CRBM, CREA, and TBIL assays.
The document describes the performance of the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, and the VITROS XT 7600 Integrated System. The main purpose of the study is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a dedicated table format for each performance metric, but rather describes how results were evaluated in the "Specificity" section and implies acceptance based on the comparison to predicate devices and established guidelines. For the method comparison, precision, linearity, and detection limits, the "reported device performance" is the direct result of the testing.
Given the nature of the submission (510(k) for substantial equivalence in an in-vitro diagnostic device), the acceptance criteria would typically revolve around demonstrating comparable performance to the predicate devices and adherence to established clinical laboratory standards (CLSI guidelines).
Below is a table summarizing the reported performance, with implied acceptance criteria based on standard practices for demonstrating substantial equivalence for in-vitro diagnostic devices.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Implied Acceptance Criteria (Based on Substantial Equivalence and CLSI Guidelines) | Reported Device Performance (VITROS XT 7600 Integrated System with corresponding slides) |
|---|---|---|
| Method Comparison | Device results should show substantial agreement with the predicate device (e.g., slopes near 1, intercepts near 0, demonstrating agreement across the measuring range). | CRBM Serum: N=118, Deming Regression, Slope=1.00, Intercept=0.12, Test range 3.1-17.8 µg/mL. CREA Serum: N=116, Passing Bablock, Slope=0.99, Intercept=0.00, Test range 0.25-13.4 mg/dL. CREA Urine: N=122, Passing Bablock, Slope=0.99, Intercept=-0.45, Test range 3.7-331.0 mg/dL. TBIL Serum: N=125, Passing Bablock, Slope=0.99, Intercept=0.01, Test range 0.14-23.65 mg/dL. |
| Precision | Within-lab precision (Total %CV and SD) should be acceptable for clinical use and comparable to predicate device specifications (though explicit predicate precision isn't stated here, it's an implied comparison). Lower %CV indicates higher precision. | CRBM (Serum): Within Lab (Total) %CV ranges from 2.41% to 3.98% across 6 concentration levels (3.9 to 17.6 µg/mL). |
| CREA (Serum): Within Lab (Total) %CV ranges from 1.40% to 1.85% across 6 concentration levels (0.82 to 12.65 mg/dL). | ||
| CREA (Urine): Within Lab (Total) %CV ranges from 1.55% to 2.23% across 6 concentration levels (55.6 to 320.9 mg/dL). | ||
| TBIL (Serum): Within Lab (Total) %CV ranges from 1.40% to 6.72% across 5 concentration levels (0.3 to 21.6 mg/dL). | ||
| Linearity | The device should demonstrate linearity across its claimed measuring range. | The linearity studies support the claimed measuring ranges for the VITROS CRBM, VITROS CREA, and VITROS TBIL assays. |
| Detection Limits (LoB, LoD, LoQ) | Calculated detection limits should be at or below the claimed LoQ and support the low end of the claimed measuring range. Acceptance typically involves comparing these values to the claimed LoQ. | CRBM: LoB = 0.6108 µg/mL; LoD = 0.6821 µg/mL; LoQ = 2.6860 µg/mL. Claimed LoQ = 3.0 µg/mL. |
| TBIL: LoB = 0.0378 mg/dL; LoD = 0.0722 mg/dL; LoQ = 0.0616 mg/dL. Claimed LoQ = 0.10 mg/dL. | ||
| Creatinine (Serum/Plasma): LoB = 0.0933 mg/dL; LoD = 0.0991 mg/dL; LoQ = 0.1119 mg/dL. Claimed LoQ = 0.15 mg/dL. | ||
| Creatinine (Urine): LoB = 1.9973 mg/dL; LoD = 2.1986 mg/dL; LoQ = 2.0060 mg/dL. Claimed LoQ = 3.2 mg/dL. | ||
| In all cases, the calculated LoQ is at or below the claimed LoQ, supporting the claimed assay range. | ||
| Specificity (Interference) | Observed bias due to interferents should be within predetermined Maximum Allowable Interference (MAI) or within the 95% Confidence Limit if exceeding Claimed Bias, demonstrating comparable performance to the predicate for known and potential interferents. | Results demonstrate acceptable bias on the VITROS XT 7600 versus the VITROS 5600 for currently claimed interferents. Two previously untested analyte/interferent levels (3.0 ug/mL CRBM/ 20 mg/dL Bilirubin and 3.0 ug/mL CRBM/ 3.0 mg/dL Ethamsylate on CRBM MicroSlides) yielded new information. One new interfering substance, Tolazamide, was identified for CREA(s) MicroSlides. The bias profiles for these demonstrated equivalent magnitudes to the VITROS 5600. The IFU for CRBM and CREA have been updated to claim the additional interfering levels and the new interfering substance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Method Comparison Test Set:
- CRBM: 118 human serum samples.
- CREA: 116 human serum samples and 122 human urine samples.
- TBIL: 125 human serum samples.
- Data Provenance: The document states "human serum samples" and "human urine samples," implying these are clinical samples. The country of origin and whether the data is retrospective or prospective is not specified.
-
Precision Test Set: For each assay (CRBM, CREA serum, CREA urine, TBIL), the study involved:
- 80 replicates (N=80) for each of the multiple fluid levels (e.g., 6 for CRBM, 6 for CREA serum, 6 for CREA urine, 5 for TBIL). The total number of analyses is much higher (e.g., 80 replicates x 6 levels = 480 for CRBM).
- The samples used were Quality Control fluids and human-based precision fluids.
- Data Provenance: Not specified.
-
Linearity Test Set: A series of eleven proportionally related admixtures of low and high test fluids. Each sample was tested in triplicate.
- Data Provenance: Not specified.
-
Detection Limits (LoB, LoD, LoQ) Test Set:
- LoB: 4 blank samples, tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot).
- LoD: 4 pools of human samples with analyte concentrations close to the expected detection limit, tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day, for a total of 216 observations (72 results per reagent lot).
- LoQ: 4 pools of low level samples, tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot).
- Data Provenance: The LoD and LoQ studies used "human samples." The country of origin and whether the data is retrospective or prospective is not specified.
-
Specificity (Interference) Test Set: Chemical interferents, common chemical substances, and claimed non-interferents, including hemoglobin, bilirubin, and intralipid. Testing employed "paired-difference" assessment at a minimum of two analyte levels.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device measures quantitative concentrations of specific analytes (Carbamazepine, Creatinine, Total Bilirubin). Ground truth for these types of in vitro diagnostic devices usually refers to the reference method (predicate device in this case) or a highly accurate reference standard rather than expert interpretation in the way it applies to image analysis or clinical diagnosis. The document does not mention human experts establishing ground truth in the context of radiologists or similar clinical diagnosticians. The ground truth for the method comparison study was established by the predicate device, VITROS 5600 Integrated System.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
None mentioned. Adjudication methods are typically used when there's a subjective element to ground truth establishment, often involving multiple human readers for diagnostic image interpretation. For quantitative measurements in clinical chemistry, the "truth" is established by reference methods, precision, and linearity studies, not by human 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, particularly in radiology or pathology, and often involves AI assistance. This document describes an automated in-vitro diagnostic device for quantitative chemical measurements, where human interpretation of results is direct measurement rather than subjective assessment. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are, in essence, standalone performance evaluations of the VITROS XT 7600 Integrated System itself, with the VITROS Chemistry Products slides, operating automatically without continuous human intervention during the measurement process. The system performs the tests, generates results, and its performance (method comparison, precision, linearity, detection limits, specificity) is evaluated. The comparison is against a predicate device, which is also an automated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the test set, especially for the method comparison, was established by comparison to the legally marketed predicate device (VITROS 5600 Integrated System), which itself would have been previously cleared based on demonstrating accuracy against established reference methods or accepted gold standards for each analyte. For precision, linearity, and detection limits, the ground truth is established by the known characteristics of reference materials and statistical analysis.
8. The sample size for the training set
The document does not mention a training set. This is because the device described is not an AI/ML-based diagnostic algorithm that learns from data. It is a traditional in-vitro diagnostic instrument with chemical reagent slides. The studies are validation studies for the performance of the integrated system, not for training an algorithm.
9. How the ground truth for the training set was established
Since there is no training set mentioned or used for this type of device, this question is not applicable.
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Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).
Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.
The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.
Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.
Here's the breakdown of the information that is applicable from your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Teco Creatinine Enzymatic Reagent Kit) |
|---|---|---|
| Intended Use | Quantitative determination of creatinine in human serum | Quantitative determination of creatinine in human serum |
| Specimen | Serum | Serum |
| Methodology | Enzymatic | Enzymatic |
| Linearity (Measuring Range) | Comparable to predicate (0.04 to 5.1 mg/dL for serum) | 0.37 - 5.06 mg/dL |
| Correlation (R²) | High correlation with predicate (R closer to 1.0) | R² = 0.9986 (compared to predicate) |
| Storage | 2-8 °C | 2-8 °C |
| Intra-assay Repeatability | Low CV% (e.g., |
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(160 days)
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Uritek TC-201 Urine Chemistry Test System consists of Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Microalbumin Creatinine (UAC) Strips for testing in the clinical laboratory. The analyzer can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically.
The Uritek TC-201 Urine Analyzer reports semi-quantitative assays for microalbumin and creatinine. Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument.
The Urine Microalbumin Creatinine (UAC) Strips are urine test strips of which microalbumin and creatinine reagent pad are affixed onto the firm plastic strips. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. UAC strips provide tests for the semi-quantitative detection of Microalbumin (low concentration of Albumin) and Creatinine and determination of the Albumin to Creatinine ratio (A : C) in urine.
The document describes the Uritek TC-201 Urine Chemistry Test System and its performance evaluation to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides the following comparison study results for the Uritek TC-201 Urine Chemistry Test System against a predicate device:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Albumin Result | Not explicitly stated | 84.9% (n = 518) Accuracy |
| Not explicitly stated | 97.9% (n=335) Sensitivity | |
| Not explicitly stated | 86.9% (n=183) Specificity | |
| Creatinine Result | Not explicitly stated | 83.4% (n = 518) Accuracy |
| Albumin to Creatinine Ratio | Not explicitly stated | 89.9% (n=518) Accuracy |
| Not explicitly stated | 92.5% (n=255) Sensitivity | |
| Not explicitly stated | 93.16% (n=263) Specificity |
Note: The acceptance criteria are not explicitly stated in numerical form. The conclusion states that "product specifications are met" and that the data "supports the substantial equivalence to the predicate device." Therefore, the reported performance metrics are implicitly presented as meeting the unstated acceptance criteria for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: A total of 518 urine specimens were analyzed in the comparison study.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted at "three Point-of-Care sites," implying real-world clinical samples. While not explicitly stated as retrospective or prospective, the nature of a comparison study using collected specimens for analysis often points to a prospective collection for the study's purpose, though it cannot be definitively confirmed from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set. The comparison study was conducted against a "predicate device" (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis), which would have its own established accuracy and is used as the reference standard in this context.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison was primarily made against the results from the predicate device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- Effect Size of Human Readers with/without AI: Not applicable, as this device is an automated urinalysis system for chemical analysis, not an AI-assisted diagnostic imaging or interpretation system that involves human readers improving with AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the analytical performance and comparison studies described appear to be evaluations of the "algorithm only" or the device's automated performance (Urine Analyzer and Urine Microalbumin Creatinine Strips as a system). The Uritek TC-201 Urine Analyzer is an "automated, bench top instrument." The comparison study evaluates the system's performance in generating results compared to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the comparison study was established by the predicate device (Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis). The study compares the results from the Uritek TC-201 system to those obtained from the predicate device on the same urine specimens.
8. The sample size for the training set
The document does not explicitly state the sample size used for a training set. The provided information pertains to verification, validation, and a comparison study for the device's analytical performance. As a medical device for chemical analysis, training sets in the typical machine learning sense might not be directly applicable in the same way as for AI/ML-based diagnostic algorithms. Device calibration and internal validation would involve specific samples, but these are not termed "training sets" in this context.
9. How the ground truth for the training set was established
Since no specific "training set" is described for an AI/ML context, the method for establishing its ground truth is not applicable or provided. For the device itself, the "self-calibration with the white area located at the back of the test strip bed" is mentioned, which serves a calibration function.
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The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.
The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.
The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are to be read by the Mission® U120 Ultra Urine Analyzer.
The Mission® Liquid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
Here's an analysis of the acceptance criteria and study information provided for the MISSION® U120 Ultra Urine Analyzer and associated reagent strips and controls:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical accuracy study in terms of specific percentages for accuracy, sensitivity, and specificity. However, it presents the reported performance values. We can infer that these values were deemed acceptable for substantial equivalence.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Mission® U120 Ultra) |
|---|---|---|
| Albumin Results | ||
| Overall Accuracy | Not explicitly stated, likely similar to predicate if not superior for substantial equivalence. | 86.5% (n=429) |
| Sensitivity | Not explicitly stated. | 97.6% (n=293) |
| Specificity | Not explicitly stated. | 92.6% (n=136) |
| Albumin-to-Creatinine Ratio | ||
| Overall Accuracy | Not explicitly stated. | 90.7% (n=429) |
| Sensitivity | Not explicitly stated. | 93.1% (n=233) |
| Specificity | Not explicitly stated. | 94.9% (n=196) |
Regarding the Precision Study:
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Mission® U120 Ultra) |
|---|---|---|
| Agreement with target concentration for within-run and between-run precision | Not explicitly stated, but likely >95% or similar to predicate. | Over 99% agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Accuracy: A total of 429 urine specimens were used.
- Data Provenance: The specimens were "randomly collected at three clinical sites from patients." The document does not specify the country of origin, but given the FDA filing, it's typically understood to be within the United States or from sites compliant with US regulations. The data is prospective as it involves new testing of collected specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the clinical study data for accuracy involved comparing the Mission® U120 Ultra Urine Analyzer results against those obtained from a predicate device (Clinitek Microalbumin 2 Reagent Strips read by Clinitek Status Analyzer).
Therefore, the "ground truth" for the clinical accuracy study was established by the predicate device's readings, rather than by human experts directly interpreting raw data. No specific number of experts or their qualifications are mentioned in this context, as the comparison is device-to-device.
4. Adjudication Method for the Test Set
Not applicable. The study compares the new device's readings against a predicate device. There is no mention of an adjudication method involving human experts.
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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done. The reported accuracy, sensitivity, and specificity for Albumin and Albumin-to-Creatinine Ratio are based on the Mission® U120 Ultra Urine Analyzer's readings without human intervention. The device is described as a "reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas," indicating automated measurement.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy study was established by comparison with a legally marketed predicate device: "Clinitek Microalbumin 2 Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947)." This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices.
For the precision study, control solutions (Level 1, Level 2, Level 3) with defined target concentrations were used as ground truth.
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 models. Given that the device is a reflectance photometer, its "training" would involve calibration and optimization during its development. This document focuses on the validation of the finished product. Therefore, no sample size for an AI/ML training set is provided.
9. How the Ground Truth for the Training Set was Established
As no specific "training set" in the AI/ML sense is mentioned, this question is not directly applicable. For the precision and accuracy studies, the ground truth was established as described in points 3 and 7. The device's internal calibration would have been established by the manufacturer during its development using reference materials and established laboratory methods.
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ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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 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 Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, sodium azide.
ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.
1. Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (ELITech Clinical Systems CREATININE PAP SL) |
|---|---|---|
| Precision (Serum/Plasma) | CV% within acceptable clinical range | Level 1: Within-run CV 1.2%, Total CV 1.9% |
| Level 2: Within-run CV 0.6%, Total CV 1.7% | ||
| Level 3: Within-run CV 0.5%, Total CV 1.5% | ||
| Precision (Urine) | CV% within acceptable clinical range | Level 1: Within-run CV 0.8%, Total CV 2.2% |
| Level 2: Within-run CV 0.7%, Total CV 2.3% | ||
| Level 3: Within-run CV 1.9%, Total CV 2.9% | ||
| Linearity (Serum/Plasma) | Valid measuring range for clinical use | 0.10 to 30 mg/dL (Manual dilution 1 to 5 allows up to 150 mg/dL) |
| Linearity (Urine) | Valid measuring range for clinical use | 5 to 450 mg/dL |
| Limit of Detection (LoD) (Serum/Plasma) | Low enough for accurate diagnosis | 0.02 mg/dL |
| Limit of Quantification (LoQ) (Serum/Plasma) | Low enough for accurate diagnosis | 0.08 mg/dL |
| Limit of Detection (LoD) (Urine) | Low enough for accurate diagnosis | 0.5 mg/dL |
| Limit of Quantification (LoQ) (Urine) | Low enough for accurate diagnosis | 2.0 mg/dL |
| Interference (Serum/Plasma) | No significant interference from common substances at specified levels | No significant interference from unconjugated bilirubin (30.0 mg/dL), triglycerides (3000 mg/dL), hemoglobin (500 mg/dL), uric acid (20.0 mg/dL), glucose (500 mg/dL), ascorbic acid (20 mg/dL), creatine (5 mg/dL), conjugated bilirubin (14.8 mg/dL). Methyl-dopa, L-dopa, and Calcium dobesilate induce falsely low results at therapeutic concentrations. Monoclonal gammopathies may cause unreliable results. |
| Interference (Urine) | No significant interference from common substances at specified levels | No significant interference from Conjugated bilirubin (29.5 mg/dL), Hemoglobin (500 mg/dL), Ascorbic acid (20 mg/dL), Calcium dobesilate (50.0 mg/dL), Glucose (539 mg/dL), Methyldopa (10 mg/dL). |
| Method Comparison (Serum/Plasma) | Strong correlation with predicate device | y = 0.979x + 0.05 mg/dL, r = 1.000, r² = 1.000, Sy.x = 0.09 mg/dL |
| Method Comparison (Urine) | Strong correlation with predicate device | y = 1.063x + 2 mg/dL, r = 1.000, r² = 0.999, Sy.x = 4 mg/dL |
| Matrix Comparison (Plasma) | Strong correlation with serum samples | y = 0.981x + 0.03 mg/dL, r = 1.000, r² = 1.000, Sy.x = 0.09 mg/dL |
| Stability (Reagent) | On-board stability and shelf-life as claimed | On-board stability: 28 days. Shelf-life: 20 months (real-time for 3 batches). |
| Stability (Control Material) | Shelf-life and reconstituted stability as claimed | Shelf-life 24 months (lyophilized). Reconstituted: 12 hours (15-25°C), 5 days (2-8°C), 4 weeks (-25° to -15°C). |
| Stability (Calibrator Material) | Shelf-life and reconstituted stability as claimed | Shelf-life 24 months (lyophilized). Reconstituted: 8 hours (15-25°C), 2 days (2-8°C), 4 weeks (-25° to -15°C). |
| Stability (Urine Control) | Shelf-life and opened stability as claimed | Shelf-life 10 months. Opened: 30 days (2-8°C). |
2. Sample Sizes and Data Provenance:
- Test Set Sample Sizes:
- Precision (Serum/Plasma and Urine): 80 measurements per level (3 levels for each matrix).
- Method Comparison (Serum/Plasma): 100 patient serum samples.
- Method Comparison (Urine): 54 patient urine samples.
- Matrix Comparison (Plasma): 43 patient plasma samples (lithium heparin).
- Detection Limit (Serum/Plasma and Urine): 15 measurements of 4 samples for LoD and LoQ for each matrix.
- Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. However, the studies were conducted by ELITech Clinical Systems SAS, which is located in France, suggesting the data may originate from a European setting. The methodology described (e.g., patient sample testing, specific protocols) implies these were prospective studies where samples were collected and tested as part of the validation process.
3. Number of Experts and Qualifications for Ground Truth:
The document describes performance studies for an in-vitro diagnostic (IVD) reagent for creatinine measurement. For such devices, "ground truth" is typically established by reference methods or validated comparative methods.
- No human experts were used to establish ground truth for the test values of the samples in the analytical performance studies (precision, linearity, detection limit, interference). These are determined by the measurements themselves and compared against established analytical criteria and industry standards.
- For Traceability, ELITech Clinical Systems ELICAL 2 calibrator values are traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method. This is considered the "gold standard" for accuracy in many clinical chemistry analytes and represents the highest level of ground truth for calibration.
- For Method Comparison, the "ground truth" for the comparative study was the results obtained from the predicate device, the Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer. The predicate device itself has undergone its own validation and regulatory clearance processes.
4. Adjudication Method:
- None. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images generates the ground truth, and discrepancies between readers need to be resolved. This document describes an IVD device for quantitative chemical analysis, where measurements are objective and do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC comparative effectiveness study was not done. These studies are relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists interpreting images). This device is an in-vitro diagnostic reagent and does not involve human readers in the diagnostic process beyond performing the test and interpreting the quantitative result.
6. Standalone (Algorithm Only) Performance:
- Yes, effectively. The performance described (precision, linearity, detection limits, interference, method comparison) represents the standalone performance of the ELITech Clinical Systems CREATININE PAP SL reagent as performed on the ELITech Clinical Systems Selectra Pro Series Analyzers, without human interpretation as part of the measurement process itself. The "algorithm" here is the enzymatic colorimetric assay methodology of the reagent combined with the automated analyzer.
7. Type of Ground Truth Used:
- Primarily Expert Concensus (ID-MS Traceability) and Comparative Method (Predicate Device):
- For calibration and absolute accuracy, the calibrator (ELICAL 2) is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method, which is a highly accurate, consensus-driven method used by reference laboratories to establish true values.
- For method comparison, the ground truth was established by the predicate device (Roche Diagnostics CREP2 on a cobas c111 analyzer). The performance of the new device was compared against this already legally marketed and validated method.
- For analytical performance characteristics like precision, linearity, detection limits, and interference, the "ground truth" is defined by adherence to established analytical protocols (CLSI guidelines) and the reproducibility/accuracy of the measurements themselves in controlled conditions.
8. Sample Size for the Training Set:
- Not explicitly stated/Not applicable in the traditional sense. This is an in-vitro diagnostic reagent, not an AI/machine learning model that typically involves a "training set" in the computational sense.
- However, the development of such reagents involves extensive research and development, including formulation, optimization, and preliminary testing, which could be considered an analogous "training" phase to refine the product. The document highlights the use of CLSI standard protocols for performance evaluation, which are used to test the final product, not to "train" it.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the traditional AI/ML sense. For an IVD reagent, the "ground truth" during its development (analogous to training) would involve:
- Chemical principle validation: Ensuring the enzymatic reaction effectively measures creatinine.
- Formulation optimization: Through numerous experiments, determining optimal concentrations of reagents for sensitivity, specificity, and stability.
- Calibration standards: Developing and validating calibrators against recognized reference materials (like ID-MS) to ensure accurate quantification across the measuring range.
- This iterative process relies on established chemical principles, analytical instrumentation, and validation against known standards and samples with established values, often aligned with international reference methods.
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