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510(k) Data Aggregation
(264 days)
CDS
The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.
The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.
The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per K061597, K090109, K092849, K093297, and K113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.
The epoc Blood Urea Nitrogen Test and epoc Total Carbon Dioxide Test, as part of the epoc Blood Analysis System, are intended for use by trained medical professionals as an in vitro diagnostic device for quantitative testing of heparinized or un-anticoagulated arterial, venous or capillary whole blood.
The acceptance criteria and device performance are described in several studies:
Acceptance Criteria and Device Performance:
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LoB, LoD, LoQ per CLSI EP17-A2) | Not explicitly stated as acceptance criteria, but demonstrates detection limits. | BUN: LoB 2 mg/dL, LoD 3 mg/dL, LoQ 3 mg/dL |
| TCO2: LoB 4.0 mM, LoD 4.3 mM, LoQ 4.3 mM | ||
| Linearity (per CLSI EP06-A) | Not explicitly stated as acceptance criteria, but demonstrates linearity across reportable range. | BUN (4-119 mg/dL): Slope 1.020, Intercept 0.4, R 0.9989 |
| TCO2 (4-49 mmol/L): Slope 0.903, Intercept 3.32, R 0.9997 | ||
| Precision (Aqueous Controls) (CLSI EP05-A3) | Not explicitly stated as acceptance criteria, but demonstrates precision. | BUN High Level (51.7 mg/dL): SWR 1.01 (2.0% CV), ST 1.16 (2.3% CV) |
| BUN Low Level (7.1 mg/dL): SWR 0.30 (4.2% CV), ST 0.32 (4.5% CV) | ||
| TCO2 High Level (30.7 mmol/L): SWR 0.82 (2.7% CV), ST 0.92 (3.0% CV) | ||
| TCO2 Low Level (16.2 mmol/L): SWR 0.88 (5.4% CV), ST 1.02 (6.3% CV) | ||
| Interference (CLSI EP07-A2) | Unacceptable interference bias defined as producing a significant error more than 5% of the time. | Clinically significant interfering substances for BUN and TCO2 are itemized and reported. Various exogenous and endogenous interferences were tested and found to be clinically insignificant below certain thresholds. |
| Clinical Field Precision (Aqueous Controls) (CLSI EP05-A3) | Not explicitly stated as acceptance criteria, but demonstrates precision in a clinical setting. | BUN Level 1 (52.1 mg/dL): SWR 1.06 (2.0%), Total Reproducibility 1.54 (3.0%) |
| BUN Level 2 (17.7 mg/dL): SWR 0.45 (2.5%), Total Reproducibility 1.11 (6.3%) | ||
| BUN Level 3 (7.1 mg/dL): SWR 0.24 (3.4%), Total Reproducibility 0.26 (3.7%) | ||
| TCO2 Level 1 (15.9 mM): SWR 0.44 (2.8%), Total Reproducibility 0.50 (3.1%) | ||
| TCO2 Level 2 (19.7 mM): SWR 0.66 (3.4%), Total Reproducibility 0.78 (3.9%) | ||
| TCO2 Level 3 (30.4 mM): SWR 0.58 (1.9%), Total Reproducibility 1.05 (3.4%) | ||
| Clinical Field Precision (Whole Blood) | Not explicitly stated as acceptance criteria, but demonstrates precision in a clinical setting. | BUN Hi-Syringe (57.4 mg/dL): %CV 2.3% |
| BUN Lo-Cap Tube (7.6 mg/dL): %CV 7.0% | ||
| TCO2 Hi-Syringe (36.5 mM): %CV 1.5% | ||
| TCO2 Lo-Cap Tube (13.5 mM): %CV 3.5% | ||
| Method Comparison (BUN) (CLSI EP09-A3) | Not explicitly stated as a numerical acceptance criterion, but implies a high correlation with the reference method. | Comparing epoc BUN to Roche Cobas 8000: Slope 0.985, Intercept 0.3, R 0.998, Mean Bias at 26 mg/dL -0.1+0.2 |
| Method Comparison (TCO2) | Not explicitly stated as a numerical acceptance criterion, but implies a high correlation with the reference method. | Comparing epoc TCO2 to i-STAT-CHEM8+: Slope 1.039, Intercept -0.8, R 0.974, Mean Bias at 20 mM 0.0+0.2 |
| Matrix Comparison: Anticoagulant | No significant difference between results in Li-heparinized, Na-heparinized, and non-anticoagulated blood samples | Concluded no significant difference in BUN and TCO2 results. |
Study Information:
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Sample sizes used for the test set and the data provenance:
- Analytical Sensitivity (LoB, LoD, LoQ): Test samples were prepared from dialyzed whole blood. The specific number of samples or runs is not explicitly stated, but the study was conducted according to CLSI EP17-A2.
- Linearity: Multiple whole blood samples were used, spanning the reportable range. Conducted per CLSI EP06-A. Specific number not provided.
- Precision (Aqueous Controls): 320 replicates for each level of both BUN and TCO2. These were in-house measurements.
- Clinical Field Precision (Aqueous Controls): N=170 for BUN Level 1, 171 for Level 2, 168 for Level 3. N=172 for TCO2 Level 1, 170 for Level 2, 169 for Level 3. Data provenance is from "three different clinical sites."
- Clinical Field Precision (Whole Blood): N=134-136 for BUN samples, N=134-139 for TCO2 samples, depending on the type (syringe/cap tube) and level (high/NB/low). Data provenance is from "three different clinical sites."
- Precision (Duplicate Epoc Test Results): Over 430 patient tests run in duplicate. "Approximately equal numbers of venous, arterial and capillary samples." Data provenance not explicitly stated (e.g., country of origin), assumed to be from clinical sites in the context of "Clinical Field Precision." This is prospective clinical data.
- Method Comparison (BUN): N=433 venous, arterial, and capillary blood samples. Performed at "three clinical sites." This is prospective clinical data.
- Method Comparison (TCO2): N=574 venous, arterial, and capillary patient samples. Performed at "three clinical sites." This is prospective clinical data.
- Matrix Comparison: Anticoagulant: Over 60 volunteer donors, with samples further aliquoted into 3 vacutainers each. Data provenance not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quantitative diagnostic test for chemical analytes (BUN, TCO2), not an imaging or qualitative diagnostic device requiring expert interpretation for ground truth. The ground truth for analytical performance studies is typically established using reference methods (e.g., IDMS-traceable laboratory system) or prepared reference materials.
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Adjudication method for the test set: Not applicable. The ground truth for quantitative chemical analytes is established by reference methods or gravimetric preparation, not through human adjudication.
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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 device is a diagnostic testing system for chemical analytes, not an AI-assisted diagnostic imaging or qualitative interpretation tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the entire performance characterization (analytical sensitivity, linearity, precision, interference, method comparison, and matrix comparison) represents standalone algorithm/device performance. The device provides quantitative results directly. Human-in-the-loop performance is about accuracy of human readers, and the clinical field precision study assesses the precision of the device in the hands of intended users, not the interpretative performance of those users.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Sensitivity, Linearity, Precision: Ground truth established via prepared reference materials (dialyzed whole blood, gravimetric mixtures of high/low samples) and aqueous controls with known concentrations.
- Method Comparison (BUN): Ground truth established by an "IDMS-traceable plasma/serum-based laboratory system" (
Roche Cobas 8000). - Method Comparison (TCO2): Ground truth established by a "whole blood point-of-care system" (
i-STAT-CHEM8+), which is also a predicate device. - Interference and Matrix Comparison: Comparisons were made against control samples (e.g., solvent added, or anticoagulant-free) to assess the impact of interfering substances or different matrices.
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The sample size for the training set: Not applicable. This document describes the performance of a chemical analyte detection system, not a machine learning or AI model that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this device.
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(257 days)
CDS
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.
The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.
Acceptance Criteria and Device Performance Study for GenChem, Inc. BUN Reagent
This document outlines the acceptance criteria and the results of a study demonstrating the performance of the GenChem, Inc. Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent (K040973).
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Based on NCCLS EP3-T guidelines; generally low %CV for various BUN levels. | Serum 1 (7.1 mg/dL): Within Run %CV = 9.1%, Total %CV = 9.4% |
| Serum 2 (35.4 mg/dL): Within Run %CV = 1.8%, Total %CV = 1.9% | ||
| Serum 3 (63.8 mg/dL): Within Run %CV = 0.8%, Total %CV = 1.3% | ||
| Urine 1 (21.7 mg/dL): Within Run %CV = 4.1%, Total %CV = 3.8% | ||
| Urine 2 (112.2 mg/dL): Within Run %CV = 0.7%, Total %CV = 1.1% | ||
| Linearity/Reportable Range | Demonstrates linearity across the stated analytical range with a high correlation coefficient and low intercept/slope deviation from ideal. | Slope = 0.995, Intercept = -0.12, Standard Error of Estimate = 0.49, r² = 1.00 |
| Analytical Range: 2 - 150 mgN/dL (Normal); 150 - 300 mgN/dL (ORDAC*) | ||
| Sensitivity | Observed sensitivity limit to be ≤ claimed limit. | Claimed Limit = 2 mg/dL |
| Observed Sensitivity Limit (3 SD) = 1.43 mg/dL | ||
| Analytical Specificity | No adverse effect from common interferents at specified concentrations. | Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) showed no adverse effect on 15 mg/dL BUN sample. |
| Method Comparison (Correlates with Predicate Device) | Strong correlation with the predicate device across the analytical range, indicated by high R² value, slope close to 1, and intercept close to 0. | Serum (N=80): Intercept = -0.3, Slope = 0.995, R² = 0.999 |
| Plasma (N=80): Intercept = -0.2, Slope = 0.989, R² = 0.998 | ||
| Urine (N=79): Intercept = 0.9, Slope = 0.979, R² = 1.000 |
*ORDAC: Off-Range Dilution and Concentration
2. Sample Size and Data Provenance (Test Set)
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Precision/Reproducibility:
- Sample Size: 60 replicates for each of 5 samples (3 serum, 2 urine) (N=60 for each sample type). Assayed twice per day in triplicate on 10 different days over a 30-day period.
- Data Provenance: Not explicitly stated, but likely from laboratory controlled samples (control sera, diluted urine pools). This is typically a retrospective analysis of controlled lab materials.
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Linearity/Assay Reportable Range:
- Sample Size: Analyzed 7 commercially available linearity standards ranging from 0 to 158 mg/dL in triplicate.
- Data Provenance: Commercially available linearity standards, typically retrospective analysis in a controlled lab setting.
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Sensitivity:
- Sample Size: 21 replicates of a diluted serum control.
- Data Provenance: Diluted serum control, typically retrospective analysis in a controlled lab setting.
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Analytical Specificity:
- Sample Size: Not explicitly stated as a numerical sample size but involved testing stock samples with varying concentrations of interferents (Hemoglobin, Bilirubin, Lipemia) against a base pool.
- Data Provenance: Laboratory-prepared stock solutions and base pool, typically retrospective analysis in a controlled lab setting.
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Patient Comparison (Method Comparison):
- Sample Size: 80 serum specimens, 80 plasma specimens, and 79 urine specimens.
- Data Provenance: "Collected from adult patients." This indicates prospective or retrospective patient sample collection, but the context generally implies real patient samples that were de-identified and used for the study. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The studies described in the provided text are for an in vitro diagnostic reagent and system. For such devices, "ground truth" is typically established by comparative analysis with a well-characterized reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical data.
- For Precision, Linearity, Sensitivity, and Analytical Specificity: Ground truth is established by the inherent properties of the reference materials used (e.g., certified control sera, linearity standards with known concentrations) or by accepted laboratory analytical methods. No external "experts" (like radiologists) are involved in establishing this type of ground truth.
- For Patient Comparison: The "ground truth" for the test set (GenChem BUN reagent) is the measurement obtained from the predicate device (Beckman BUN reagent for the CX3). The "experts" in this context would be the skilled laboratory technicians operating the instruments, but their role is to accurately perform the assays, not to interpret an uncertain "ground truth."
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in studies where subjective interpretation (e.g., imaging reads) is involved and discrepancies between readers need to be resolved. For an IVD reagent, data is quantitative and is compared statistically. Therefore, no adjudication method as typically understood in image-based studies was used. The comparison was a direct statistical correlation between the test device and the predicate device's quantitative results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiologists reading images and improved performance with AI assistance). The GenChem BUN Reagent is an automated in vitro diagnostic assay where the output is a quantitative value, not subject to human interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, all performance studies described are essentially standalone performance studies for the reagent on the Beckman CX3® Synchron Analyzer. The analytical performance characteristics (Precision, Linearity, Sensitivity, Analytical Specificity, and Method Comparison) measure the reagent's performance as an "algorithm only" (in the sense of an automated test system yielding a quantitative result without direct human interpretation influencing the result itself). The human "in the loop" would be operating the instrument and performing quality control, but not providing an interpretation that the algorithm augments or replaces.
7. Type of Ground Truth Used
The primary ground truth used for the method comparison study (patient comparison) was the predicate device's measurement (Beckman BUN reagent for the CX3). For other performance characteristics like precision, linearity, and sensitivity, the ground truth was established by reference materials, certified standards, or accepted laboratory methods (e.g., known concentrations of linearity standards, the mean value for precision calculations). This is synonymous with a form of expert consensus if the reference methods are considered the established gold standard.
8. Sample Size for the Training Set
The provided documentation describes performance studies for regulatory submission (510(k)). These are analytical validation studies, not machine learning model development. Therefore, there is no explicit "training set" in the context of an AI/ML algorithm. The "training" in this context refers to the development and optimization of the reagent and its methods, which would typically be done by the manufacturer through various iterations using proprietary internal samples and methodologies, but these are not disclosed as a "training set" in a regulatory submission for an IVD reagent.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The development of chemical reagents and analytical methods for IVD devices involves extensive R&D and optimization, where "ground truth" is established against known chemical properties, reference methods, and clinical needs during the development phase.
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(123 days)
CDS
Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine on Beckman Synchron CX & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.
Urea nitrogen concentration is determined by an enzymatic conductivity method employing a Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
Acceptance Criteria and Device Performance for Mission Diagnostic BUN Reagent
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. However, the performance characteristics (precision, method comparison, and recovery) are compared against a predicate device, implying that performance similar to or better than the predicate is considered acceptable.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Mission BUN Reagent) |
|---|---|---|
| Precision | CV% within acceptable ranges for clinical applications and comparable to predicate. | Serum Control 1 (13 mg/dL): Total CV = 5.8% |
| Serum Control 2 (48 mg/dL): Total CV = 6.5% | ||
| Urine Control 1 (58 mg/dL): Total CV = 3.3% | ||
| Urine Control 2 (63 mg/dL): Total CV = 4.0% | ||
| Method Comparison (Serum) | Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate. | Equation: Mission = 0.892 x Beckman + 1.22 |
| Range: 4 to 87 mg/dL | ||
| $r^2$: 0.997 | ||
| S(yx): 1.30 mg/dL | ||
| Method Comparison (Urine) | Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate. | Equation: Mission = 0.923 x Beckman + 1.054 |
| Range: 4 to 100 mg/dL | ||
| $r^2$: 0.996 | ||
| S(yx): 1.70 mg/dL | ||
| Recovery to Expected Values (Serum) | Similar average % recovery to predicate across concentration ranges, ideally within 80-120%. | Range: 82 – 106% |
| Overall Mean: 97% | ||
| Recovery to Expected Values (Urine) | Similar average % recovery to predicate across concentration ranges, ideally within 80-120%. | Range: 85.7 – 103.8% |
| Overall Mean: 97.6% | ||
| **Functional Sensitivity (Lowest level with |
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