Search Results
Found 8 results
510(k) Data Aggregation
(257 days)
BUN REAGENT
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)
-
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.
-
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.
-
Sensitivity:
- Sample Size: 21 replicates of a diluted serum control.
- Data Provenance: Diluted serum control, typically retrospective analysis in a controlled lab setting.
-
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.
-
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.
Ask a specific question about this device
(123 days)
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
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 |
Ask a specific question about this device
(71 days)
ATAC PAK BUN REAGENT
The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.
The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.
This document focuses on the ATAC PAK BUN Reagent Kit, an in-vitro diagnostic device designed for the quantitative determination of urea nitrogen. The provided text describes the device's performance characteristics and how they demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear from 2 to 100 mg/dL | (ATAC Recoveries) = 0.6 mg/dL + 0.9775 x (Standard Value), sy.x = 1.2 mg/dL. The recovery of urea nitrogen is linear from 2 to 100 mg/dL. |
| Precision (Within Run) | Not explicitly stated but implied to be low CV% to demonstrate reliability | Serum 1: n=60, mean=7 mg/dL, 1SD=0.3, %CV=4.4% |
| Serum 2: n=60, mean=34 mg/dL, 1SD=0.5, %CV=1.5% | ||
| Serum 3: n=60, mean=61 mg/dL, 1SD=0.9, %CV=1.4% | ||
| Urine 1: n=60, mean=21 mg/dL, 1SD=0.4, %CV=2.1% | ||
| Urine 2: n=60, mean=80 mg/dL, 1SD=1.0, %CV=1.3% | ||
| Precision (Total) | Not explicitly stated but implied to be low CV% to demonstrate reliability | Serum 1: 1SD=0.4, %CV=5.6% |
| Serum 2: 1SD=0.8, %CV=2.3% | ||
| Serum 3: 1SD=1.1, %CV=1.9% | ||
| Urine 1: 1SD=0.5, %CV=2.5% | ||
| Urine 2: 1SD=1.4, %CV=1.7% | ||
| Method Comparison (Serum/Plasma) | Strong correlation (high r-value) and close agreement with competitive method | ATAC 8000 = 1.2 mg/dL + 0.977 x Competitive Reagent, r = 0.996 |
| Method Comparison (Urine) | Strong correlation (high r-value) and close agreement with competitive method | ATAC 8000 = 1.9 mg/dL + 0.9525 x Competitive Reagent, r = 0.991 |
| Detection Limit | 2 mg/dL | 2 mg/dL (documented by repetitive assay of diluted serum control, 30 replicates, 0 mg/dL std dev) |
| On-board Reagent Stability | 14 days; total imprecision |
Ask a specific question about this device
(61 days)
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
Ask a specific question about this device
(51 days)
HICHEM BUN REAGENT
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.
This reagent is intended for professional use only.
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Here's a breakdown of the acceptance criteria and study details for the HiChem® BUN Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implied by the comparison to the predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit). The study's goal was to demonstrate similar performance. The quantitative acceptance criteria are not explicitly stated as numerical thresholds (e.g., "within X% difference"), but rather through statistical comparisons like correlation coefficients (r) and differences in regression equations.
| Performance Metric | Acceptance Criteria (Implied - Similar to Predicate) | HiChem® Reagent Performance | Beckman® Reagent Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (7.1 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 9.1%, 9.4%, 0.65, 0.66 | 9.1%, 8.4%, 0.65, 0.60 | Yes (very similar) |
| Serum 2 (35.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 1.8%, 1.9%, 0.62, 0.66 | 1.5%, 1.6%, 0.53, 0.57 | Yes (very similar) |
| Serum 3 (63.8 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.8%, 1.3%, 0.50, 0.80 | 1.1%, 1.2%, 0.72, 0.76 | Yes (very similar) |
| Urine 1 (21.7 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 4.1%, 3.8%, 0.89, 0.82 | 2.9%, 2.9%, 0.62, 0.63 | Yes (similar) |
| Urine 2 (112.2 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.1%, 0.75, 1.25 | 0.7%, 1.2%, 0.82, 1.31 | Yes (very similar) |
| ORDAC Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (179-180 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.18, 2.58 | 0.7%, 1.2%, 1.18, 2.17 | Yes (very similar) |
| Serum 2 (258-262.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.91, 3.55 | 0.7%, 1.1%, 1.75, 2.78 | Yes (very similar) |
| Method Comparison (Serum/Plasma) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 0.999, HiChem® = -0.3 + 0.987 * Beckman® | Not applicable (comparison) | Yes (very strong correlation, small bias) |
| Method Comparison (Urine) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 1.000, HiChem® = 0.9 + 0.979 * Beckman® | Not applicable (comparison) | Yes (perfect correlation, small bias) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum/Urine Samples (non-ORDAC): For each of the 5 samples (3 serum, 2 urine), n = 60 (This represents 60 individual measurements for each sample type, collected over 10 days, assayed twice per day in triplicate).
- ORDAC Samples: For each of the 2 spiked serum samples, n = 60 (This represents 60 individual measurements for each sample type).
- Data Provenance: Not explicitly stated, but clinical laboratory studies often use control materials and patient samples from the country where the manufacturer is based (USA in this case, based on FDA submission). The study design (assaying twice per day over 30 days) suggests prospective data collection for the precision aspect.
- Patient Comparison (Method Comparison) Study:
- Serum/Plasma: n = 160
- Urine: n = 79
- Data Provenance: "collected from adult patients" - implies prospective collection of patient samples. Likely from the US, given the FDA submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of submission for a diagnostic reagent does not typically involve experts establishing a "ground truth" in the way an imaging or diagnostic AI model would. In in-vitro diagnostics, the "ground truth" is typically the quantitative result obtained from a reference method or the predicate device itself, which is assumed to be accurate.
Therefore, this section is not applicable for this device. The "ground truth" for comparison is the performance of the established, legally marketed predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit).
4. Adjudication Method for the Test Set
Not applicable. There's no subjective interpretation requiring adjudication in a quantitative diagnostic assay comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a study comparing the performance of two quantitative diagnostic reagents, not a study involving human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in the sense that the device (reagent) performance itself is being evaluated and compared to a predicate, independent of human interpretation of the results. The "algorithm" here is the chemical reaction and analytical measurement process on the SYNCHRON CX® and CX® DELTA Systems. The reported performance metrics are purely analytical measurements of the reagent's characteristics.
7. The Type of Ground Truth Used
The ground truth or reference standard for comparison is the Beckman® SYNCHRON® CX® Systems BUN Reagent Kit. This is a well-established, legally marketed predicate device, and its performance is assumed to be the "gold standard" against which the new HiChem® BUN Reagent is evaluated for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent, not an AI/ML model that requires a "training set." The development of the reagent itself would involve R&D and formulation, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
Ask a specific question about this device
(40 days)
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
The Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum, plasma or urine on both automated and manual systems.
The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum, plasma or urine. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum, plasma or urine on both automated and manual systems.
The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al. that urea concentration is proportional to absorbance change over a fixed time interval.
The series of reactions involved in the assay system is as follows:
- Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
Urea + H2O _ Urease _ 2NH3 + CO2 - In the presence of glutamate dehydrogenase (GLDH) and reduced nicotinamide adenine dinucleotide (NADH), the ammonia combines with a-ketoglutarate (a-KG) to produce L-glutamate.
NH3 + a-KG + NADH __ GLDH ___ L-Glutamate + NAD
INFINITY BUN reagent has the convenience of being a single vial reagent and also incorporates a patented dynamic stabilization process which regenerates NADH from NAD (oxidized NADH), thereby increasing the shelf life of the reagent.
The provided text describes a 510(k) summary for the INFINITY™ BUN Reagent, an in vitro diagnostic device. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not to establish new acceptance criteria or perform a de novo study the way an AI/ML product might. Therefore, many of the requested categories (like MRMC study, sample sizes for training/test sets, expert qualifications for ground truth, and adjudication methods) are not applicable or not explicitly detailed in this type of submission for a chemical reagent.
Here's a breakdown of the information provided in relation to your request, with an emphasis on what is present and what is absent:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to a previously cleared predicate device. This is typically shown through correlation studies.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (from K992800 Summary) |
|---|---|---|
| Substantial Equivalence | Demonstrated through correlation with a legally marketed predicate device, typically involving a regression analysis showing close agreement. | Correlation studies to Sigma Diagnostics BUN Reagent, Procedure No. 67 (K863196) using plasma samples yielded a regression equation of: INFINITY BUN = 0.95 (BUN 63) + 1.1 |
| Predicate Device Match | The device must be the same product as, or substantially equivalent to, a previously cleared device. | "The Sigma Diagnostics INFINITY™ BUN Reagent (Procedure No. 63) is substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477." |
Study Information
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): N=126 plasma samples were used for the correlation study.
- Data Provenance: Not specified (e.g., country of origin). The nature of the samples (plasma) suggests they are biological samples, likely collected for clinical testing, though whether they were retrospective or prospectively collected is not stated.
-
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)
- Not Applicable: For a chemical reagent, "ground truth" is typically established by the reference method or the predicate device's measurement. There are no "experts" in the sense of human interpretation like radiologists for this type of device. The ground truth for the correlation study would be the results obtained by the predicate device (Sigma Diagnostics BUN Reagent, Procedure No. 67).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are relevant for subjective interpretations (e.g., image analysis by multiple readers). For a quantitative chemical assay, the comparison is directly between the numerical results of the new device and the predicate device, not an adjudicated interpretation.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is an in vitro diagnostic (IVD) reagent, not an AI/ML device that assists human readers. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This refers to an "algorithm only" performance. For this IVD reagent, the performance is standalone in the sense that the device itself performs the measurement. There isn't an "algorithm" in the modern AI sense, but rather a chemical reaction and spectrophotometric reading that yields a quantitative result. The correlation study directly assesses this standalone performance against a predicate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: The "ground truth" for the correlation study was the quantitative measurement obtained from the predicate device (Sigma Diagnostics BUN Reagent, Procedure No. 67). This is a direct comparative measurement rather than an expert consensus or pathology result.
-
The sample size for the training set
- Not Applicable / Not Provided: This is a chemical reagent, not an AI/ML model that requires "training data." The device's performance is inherent in its chemical formulation and reaction kinetics.
-
How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no "training set" for this type of device, this question is not relevant.
Ask a specific question about this device
(41 days)
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
The Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine on both automated and manual svstems.
The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al.3 that urea concentration is proportional to absorbance change over a fixed time interval.
The series of reactions involved in the assay system is as follows:
- Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
Urea + H2O Urease
This 510(k) notification for the INFINITY™ BUN Reagent is a submission for an in vitro diagnostic device, not an AI/ML device, therefore, many of the requested categories related to AI/ML device studies are not applicable. The document states that the device is "substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477," indicating that performance is established through equivalence to a predicate device rather than a de novo study with acceptance criteria specific to this submission.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is an in vitro diagnostic (IVD) reagent intended to measure Urea Nitrogen, the typical acceptance criteria relate to analytical performance characteristics such as accuracy, precision, linearity, and interference. However, this 510(k) summary does not explicitly state specific acceptance criteria (e.g., a target accuracy percentage or precision coefficient of variation) or present a table of reported device performance data.
Instead, it relies on substantial equivalence to a previously cleared device. The implicit acceptance criterion is that the INFINITY™ BUN Reagent performs identically or equivalently to the TRACE Scientific BUN Reagent (K971477).
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. For IVD reagents, a "test set" typically refers to samples used in validation studies (e.g., patient samples, spiked samples, control materials). The document doesn't detail any specific studies conducted with this new reagent, as its equivalence is asserted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable/not provided. For an IVD reagent that measures a chemical analyte like Urea Nitrogen, "ground truth" is typically established through reference methods, certified reference materials, or highly accurate laboratory instruments, not through expert consensus in the way it would be for image analysis or clinical diagnosis by human experts.
4. Adjudication Method for the Test Set:
This is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret results, often in AI/ML performance studies to resolve discrepancies. This concept doesn't apply to the analytical performance of an IVD reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This submission is for an in vitro diagnostic reagent, not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
This is not applicable. The INFINITY™ BUN Reagent is a chemical reagent, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.
7. The Type of Ground Truth Used:
For the type of device described, the "ground truth" for evaluating its analytical performance would typically be:
- Reference Methods: Comparison against established, highly accurate laboratory methods for Urea Nitrogen measurement.
- Certified Reference Materials: Using materials with known, certified concentrations of Urea Nitrogen.
- Split Sample Comparisons: Testing patient samples with the new reagent and a predicate/reference method.
However, the 510(k) summary does not explicitly state the type of ground truth used for any specific validation studies, as it's primarily a substantial equivalence claim. The references provided (Tietz Textbook, Talke and Schubert, Tiffany et al.) relate to the scientific principles and historical context of BUN measurement methodology, not specific ground truth establishment for a validation study of this particular reagent.
8. The Sample Size for the Training Set:
This is not applicable. The INFINITY™ BUN Reagent is a chemical reagent, not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no "training set" for a chemical reagent.
Summary of Substantial Equivalence Claim:
The core of this 510(k) is the statement: "The Sigma Diagnostics INFINITY™ BUN Reagent (Procedure No. 63) is substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477." This means that the FDA's acceptance of this device's safety and effectiveness relies on its demonstrated equivalence (likely through comparative analytical performance studies, though not detailed here) to the predicate device, which has already been deemed safe and effective. The original predicate device (K971477) would have undergone its own validation studies to establish its performance characteristics against acceptance criteria relevant to its intended use.
Ask a specific question about this device
(50 days)
SIGMA DIAGNOSTICS BUN REAGENT
The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea. BUN determination, therefore, has become the most widely used screening procedure for evaluating kidney function. Increased BUN levels occur in cases of impaired kidney function such as chronic nephritis, acute glomerulonephritis, polycystic disease of the kidney, nephrosclerosis and tubular necrosis. BUN levels are also elevated due to urinary tract obstruction and during the terminal stage of liver disease. Decrease in BUN levels often accompany primary hepatic insufficiency and acute hepatitis.
The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.
This document describes a diagnostic reagent, the Sigma Diagnostics BUN Reagent, and its performance in measuring blood urea nitrogen (BUN) levels. It is not an AI/ML device, and therefore several of the requested categories are not applicable. I will provide information for the relevant categories based on the provided text.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalency to Beckman BUN Reagent Kit | Achieved; "The safety and effectiveness of Sigma Diagnostics BUN Reagent... are demonstrated by its substantial equivalency to Beckman BUN Reagent Kit, Part No. 443350." |
| Identical Reaction Principles | Achieved; "reaction principles for both are identical." |
| Correlation Coefficient (vs. Beckman BUN Reagent Kit) | 0.999 |
| Regression Equation (vs. Beckman BUN Reagent Kit) | y = 1.03x - 0.19 |
| Within-run precision (%CV) | Less than 4% |
| Total precision (%CV) | Less than 4% |
| Linearity | To 125 mg/dL |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of samples. The text mentions "serum samples" were used for the comparison study and precision evaluations.
- Data Provenance: Not specified, but implied to be from clinical laboratory testing given the nature of the device (BUN reagent). Retrospective or prospective is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a chemical reagent, not an AI/ML device relying on human interpretation of images or other subjective data. The "ground truth" for this device would be established by reference methods or validated comparative methods.
4. Adjudication method for the test set:
- Not applicable. There is no subjective interpretation involved that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent, not an algorithm. Its performance is measured directly on laboratory analyzers. The "standalone" performance here refers to its ability to accurately measure BUN concentrations.
7. The type of ground truth used:
- The "ground truth" for evaluating the Sigma Diagnostics BUN Reagent's performance was its comparison against the Beckman BUN Reagent Kit, Part No. 443350, which served as the reference or comparative method for establishing substantial equivalency. Reference methods and established clinical chemistry principles form the basis of ground truth for chemical assays.
8. The sample size for the training set:
- Not applicable. Reagents do not have "training sets" in the AI/ML sense. Their formulation and performance are optimized through chemical and analytical development.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set in the AI/ML context for this device.
Ask a specific question about this device
Page 1 of 1