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510(k) Data Aggregation
(524 days)
The Urea Nitrogen2 assay is used for the quantitation of Urea Nitrogen in human serum, plasma, or urine on the ARCHITECT c System.
The Urea Nitrogen2 assay is to used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.
The Urea Nitrogen2 assay is an automated clinical chemistry assay. The Urea Nitrogen2 assay is a modification of a totally enzymatic procedure. The test is performed as a kinetic assay in which the initial rate of the reaction is linear for a limited period of time. Urea in the sample is hydrolyzed by urease to ammonia and carbon dioxide. The second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.
The provided document is a 510(k) premarket notification for a new in vitro diagnostic device, the Urea Nitrogen2 assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical effectiveness studies as might be seen for novel devices. Therefore, the information provided primarily concerns non-clinical performance characteristics of the assay itself, rather than human-in-the-loop performance or diagnostic accuracy evaluated in a clinical setting with patient outcomes.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
Core Purpose of the Submission: To demonstrate that the Urea Nitrogen2 assay is substantially equivalent to the predicate device (Urea Nitrogen assay, K981918) for the quantitative measurement of urea nitrogen in human serum, plasma, and urine on the ARCHITECT c System. This means proving the new device performs similarly and is as safe and effective as the predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from established clinical laboratory standards (CLSI guidelines) and comparison to the predicate device's known performance. The performance metrics evaluated are standard for in vitro diagnostic assays.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Urea Nitrogen2) |
|---|---|---|
| Reportable Interval | Must cover clinically relevant range and be supported by analytical performance (LoD, LoQ, linearity, imprecision, bias). It should be comparable to or improve upon the predicate device. Predicate: Serum 2-125 mg/dL, Urine 2-1991 mg/dL. | Serum/Plasma: AMI: 2-125 mg/dL, EMI: 125-625 mg/dL, Reportable Interval: 2-625 mg/dL. Urine: AMI: 16-1991 mg/dL, Reportable Interval: 11-1991 mg/dL. (Meets/Exceeds predicate in serum/plasma upper limit, comparable in urine.) |
| Within-Laboratory Precision (Imprecision) | Based on CLSI EP05-A3 guidelines. Low %CV (Coefficient of Variation) and SD (Standard Deviation) demonstrating consistent results. Comparable to or better than predicate. Predicate: Serum %CV 1.8-2.0% (15.5-48.0 mg/dL), Urine %CV 3.1-3.8% (504.8-896.4 mg/dL). | Serum/Plasma: Samples (4-102 mg/dL) demonstrated SDs ≤ 0.4 mg/dL and %CV ≤ 2.7%. Urine: Samples (55-1605 mg/dL) demonstrated SDs ≤ 11.7 mg/dL and %CV ≤ 2.1%. (Meets/Exceeds predicate with broader range tested and generally lower %CV.) |
| Accuracy (Bias) | Low percentage bias relative to a recognized standard reference material (NIST SRM 912b). Bias should be within acceptable limits for clinical utility. | Serum: Bias ranged from 1.6% to 4.2%. Urine: Bias ranged from -1.3% to 3.0%. (Demonstrates acceptable accuracy.) |
| Lower Limits of Measurement (LoB, LoD, LoQ) | Determined by CLSI EP17-A2 guidelines. LoB, LoD, and LoQ should be low enough to be clinically useful and comparable to the predicate. Predicate Serum: LoD 0.7 mg/dL, LoQ 1.4 mg/dL. Predicate Urine: LoD 15.0 mg/dL, LoQ 40.0 mg/dL. | Serum: LoB 1 mg/dL, LoD 2 mg/dL, LoQ 2 mg/dL. Urine: LoB 6 mg/dL, LoD 11 mg/dL, LoQ 16 mg/dL. (Comparable to predicate's analytical sensitivity; slight differences but within typical ranges for this type of assay.) |
| Linearity | Device should show a linear response across its stated analytical measuring interval as per CLSI EP06-A. | Serum: Linear across 2 to 125 mg/dL. Urine: Linear across 16 to 1991 mg/dL. (Demonstrates linearity across its Analytical Measuring Interval.) |
| Interference | No significant interference (typically defined as ±10% bias) from common endogenous and exogenous substances at specified levels. The scope and levels tested should address potential clinical interferences. | Serum/Plasma (Endogenous): No significant interference (within ±10%) for Bilirubin (60 mg/dL), Hemoglobin (2000 mg/dL), Triglycerides (1500 mg/dL). Interference was observed for Total Protein (11 g/dL at 10 mg/dL analyte level: 11% (9%, 14%) CI). Serum/Plasma (Exogenous): No significant interference (within ±10%) for a broad list of drugs. Interference was observed for Cefoxitin (6600 mg/L at 10 mg/dL analyte level: 10% (6%, 14%) CI). Urine (Endogenous): No significant interference (within ±10%) for Ascorbate (200 mg/dL), Glucose (1000 mg/dL), Protein (50 mg/dL). Urine (Exogenous): No significant interference (within ±10%) for a broad list of drugs/substances. (Generally good performance, with identified interferences clearly reported.) |
| Method Comparison | High correlation and acceptable agreement (slope and intercept near 1 and 0, respectively) when compared to the predicate device on the same platform. Expected correlation coefficient near 1.00. | Serum: N=124, Correlation Coefficient=1.00, Intercept=0.74, Slope=1.02 (Concentration Range 4-123 mg/dL). Urine: N=121, Correlation Coefficient=1.00, Intercept=8.95, Slope=1.03 (Concentration Range 41-1754 mg/dL). (Excellent correlation and agreement with the predicate.) |
| Tube Type Suitability | Demonstration that the device performs acceptably with specified blood collection tube types. | Serum: Serum tubes, Serum separator tubes. Plasma: Lithium heparin tubes, Lithium heparin separator tubes, Sodium heparin tubes. (Acceptable for specified tube types.) |
| Dilution Verification | Demonstration that the automated dilution protocol yields results comparable to manual dilution. Accuracy of diluted results compared to undiluted or expected values. | % difference values for automated dilution vs. manual dilution ranged from -2.8% to -1.3%, demonstrating acceptable performance. (Acceptable performance for automated dilution.) |
Study Details
The studies described are primarily analytical performance studies, characteristic of a 510(k) submission for an in vitro diagnostic device, especially a chemical analyzer assay. They demonstrate the device's technical specifications and how it performs compared to a reference method or the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies (Within-Laboratory):
- Serum/Plasma: 3 human serum panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
- Urine: 3 human urine panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
- Data Provenance: Not explicitly stated but inferred to be laboratory-based analytical studies, likely from the manufacturer's R&D facilities. No country of origin is specified. The studies are retrospective analytical evaluations of manufactured samples and controls.
- Accuracy (Bias): 3 concentrations of standard across 3 reagent lots, 2 calibrator lots, and 1 instrument. (NIST SRM 912b is the standard).
- Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates of zero-analyte samples for LoB, n ≥ 60 replicates of low-analyte level samples for LoD/LoQ. Conducted using 3 reagent lots on 2 instruments over a minimum of 3 days.
- Linearity: Not explicitly stated sample count, but typically involves preparing a dilution series of samples across the range.
- Interference: "Each substance was tested at 2 levels of the analyte (approximately 10 mg/dL and 30 mg/dL for serum/plasma; 700 mg/dL and 1500 mg/dL for urine)." No specific N for how many replicates or individual samples are run per interferent level, but implied to be sufficient for statistical analysis (e.g., 95% CI).
- Method Comparison:
- Serum: n=124 samples.
- Urine: n=121 samples.
- Data Provenance: Not explicitly stated, but these would be clinical or proficiency samples analyzed side-by-side with the predicate.
- Tube Type: Samples collected from a minimum of 40 donors.
- Dilution Verification: 5 human serum samples (spiked with urea). Each sample tested with automated dilution and 3 manual dilutions (by 2 technicians). Tested in replicates of 5.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- For this type of in vitro diagnostic device (a quantitative chemical assay), "ground truth" is established by:
- Reference materials: e.g., NIST SRM 912b for accuracy. This is a primary standard, not established by human experts.
- Predicate device measurements: For method comparison, the predicate device provides the comparative 'truth' (or established method performance).
- Clinical laboratory professional consensus/guidelines: Standards like CLSI (Clinical and Laboratory Standards Institute) guidelines (EP05-A3, EP17-A2, EP06-A, EP07, EP09-A3, EP34) serve as the "expert consensus" on how to conduct and interpret these analytical studies. These are published by committees of experts in laboratory medicine, clinical chemistry, and statistics.
- No "expert readers" in the traditional sense (e.g., radiologists interpreting images) are involved in establishing ground truth for this type of device. The validation is based on metrological traceability to standards and comparison to an established analytical method.
4. Adjudication Method for the Test Set
- Not applicable as this is an analytical performance study of a chemical assay, not a diagnostic accuracy study relying on human interpretation of subjective data (like imaging or pathology). Results are quantitative measurements read by the instrument.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., AI-assisted image interpretation) and aim to show an improvement in human reader performance. This device is a quantitative chemical assay that provides a numerical result; there is no human "reader" to assist in the primary measurement. The comparison is between the new assay's performance and the predicate assay's performance, as well as against analytical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The entire submission details the standalone analytical performance of the Urea Nitrogen2 assay system (reagents + ARCHITECT c System instrument). Its performance (precision, accuracy, linearity, etc.) is evaluated independently of human interpretation of the final numerical result, beyond the standard operation and quality control typically performed in a clinical lab.
7. The Type of Ground Truth Used
- Analytical Standards and Reference Methods/Predicate Device:
- NIST SRM 912b: Used as the true value for accuracy determination.
- Predicate Device (Urea Nitrogen assay): Used as the comparative reference for method comparison studies, demonstrating substantial equivalence.
- CLSI Guidelines: Act as the "ground truth" for the methodologies and acceptance criteria applied to evaluate the analytical performance (e.g., how LoQ is defined and determined, how precision is calculated).
8. The Sample Size for the Training Set
- For this type of in vitro diagnostic assay, there isn't a "training set" in the machine learning sense (where an algorithm learns from data). The "training" for such an assay primarily refers to:
- Reagent formulation and optimization: This involves extensive R&D to achieve desired chemical reactions and stability.
- Instrument calibration: The ARCHITECT c System is calibrated using specific calibrators (Consolidated Chemistry Calibrator mentioned, which is itself traceable to standards) to ensure accurate measurement across the range.
- The "training" is inherent in the chemical and engineering development of the assay and the instrument, rather than an algorithmic learning process on a large dataset. Therefore, a specific "training set sample size" as one would discuss for an AI model is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As explained above, there isn't a "training set" with ground truth in the AI/ML context for this device. Instead, the assay's performance characteristics (calibration, linearity, reaction kinetics, etc.) are optimized and confirmed through:
- Chemical principles and R&D: The enzymatic reaction (urease, GLDH kinetics) is based on established biochemical mechanisms.
- Quality control materials and calibrators: These materials have assigned values, often traceable to international standards (like NIST SRM), and are used to "train" or calibrate the instrument system.
- Iterative laboratory testing and optimization: The assay's components and instrument parameters are refined through repeated experiments to meet performance specifications.
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(188 days)
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma.
sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet.
Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet.
The provided text describes the 510(k) summary for the Thermo Fisher Scientific Oy Urea/BUN, sCal, Nortrol, and Abtrol devices. The information provided focuses on demonstrating substantial equivalence to a predicate device (Bayer ADVIA 2400 Chemistry System) for laboratory diagnostic tests.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparative table (Table 1) between the new device and the predicate device for several attributes. However, it does not explicitly state pre-defined acceptance criteria (e.g., "The new device's precision must be within X% of the predicate device"). Instead, it presents the performance data for both devices, implying that the new device's performance is deemed acceptable if it is comparable to the predicate device.
Table 1: Comparison of New Device (Urea / BUN) and Predicate Device (Bayer ADVIA Urea Nitrogen (UN) assay)
| Attribute | New device #1 Reported Performance (Urea Nitrogen mg/dL) | Predicate device #1 Reported Performance (Urea Nitrogen mg/dL) |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the quantitative determination of Urea / BUN (urea nitrogen) concentration in human serum or plasma on T60 instrument. | For in vitro diagnostic use in the quantitative determination of urea nitrogen in human serum, plasma (lithium heparin), and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of kidney disease, urinary tract obstruction, and acute or chronic renal failure. |
| Indication for Use | Intended for quantitative in vitro diagnostic measurement of urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. | See intended use. |
| Assay Protocol | Urea is hydrolysed to produce ammonia and carbon dioxide. Ammonia combines with α-ketoglutarate (α-KG) and NADH in the presence of GLDH to produce L-glutamate. Decrease in absorbance at 340 nm is proportional to urea level. | Urea is hydrolyzed to produce ammonia and carbon dioxide. Ammonia reacts with 2-oxoglutarate in the presence of glutamate dehydrogenase and NADH. Oxidation of NADH to NAD is measured as an inverse rate reaction at 340/410 nm. |
| Traceability/Standardization | Value assigned using NIST SRM 909b as a primary reference. | Traceable to the CDC reference method, which uses reference materials from NIST via patient sample correlation. |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin) and urine |
| Reagent Storage | Unopened vials stable at 2...8 °C until expiration date. | Unopened reagents stable until expiration date when stored at 2°-8°C. Do not freeze reagents. |
| Expected Values | Serum, adult: Urea Nitrogen: 6 - 20 mg/dl (2.2 - 7.2 mmol/l); Urea: 13 - 43 mg/dl (2.2 - 7.2 mmol/l) | Serum: 9 - 23 mg/dL (3.2 – 8.2 mmol/L); Urine: 12 – 20 g/day (0.43 – 0.71 mol/day) |
| Instrument | T60 and DPC T60i, DPC T60i Kusti | ADVIA® 2400 Chemistry system. |
| Measuring Range | Serum: Urea nitrogen: 4.2 - 56 mg/dl (1.5 - 20.0 mmol/l); Urea: 9 - 120 mg/dl (1.5 - 20.0 mmol/l) | Serum: 5 - 150 mg/dL (1.8 – 53.6 mmol/L); Urine: 35 - 1000 mg/dL (12.5 - 357 mmol/L) |
| Precision | Within run: Level 5.7 mg/dL: SD=0.2, CV(%)= 3.1 Level 14.7 mg/dL: SD=0.2, CV(%)= 1.4 Level 24.7 mg/dL: SD=0.4, CV(%)= 1.7 Level 44.8 mg/dL: SD=0.4, CV(%)= 0.8 Between run: Level 5.7 mg/dL: SD=0.4, CV(%)= 7.4 Level 14.7 mg/dL: SD=0.1, CV(%)= 1.0 Level 24.7 mg/dL: SD=0.4, CV(%)= 1.8 Level 44.8 mg/dL: SD=0.4, CV(%)= 1.0 Total: Level 5.7 mg/dL: SD=0.5, CV(%)= 8.1 Level 14.7 mg/dL: SD=0.4, CV(%)= 2.7 Level 24.7 mg/dL: SD=0.9, CV(%)= 3.6 Level 44.8 mg/dL: SD= 1.0, CV(%)= 2.2 | Serum: Within run: Level 19 mg/dL: SD=0.3, CV(%)= 1.4 Level 67 mg/dL: SD=0.3, CV(%)= 0.5 Level 81 mg/dL: SD=0.5, CV(%)=0.7 Total: Level 19 mg/dL: SD=0.4, CV(%)= 2.2 Level 67 mg/dL: SD= 1.0, CV(%)= 1.5 Level 81 mg/dL: SD= 1.3, CV(%)= 1.6 Urine: Within run: Level 453 mg/dL: SD=10.1, CV(%)= 2.2 Level 712 mg/dL: SD=28.6, CV(%)= 4.0 Total: Level 453 mg/dL: SD= 15.2, CV(%)= 3.4 Level 712 mg/dL: SD= 30.6, CV(%)= 4.3 |
| Method Comparison | Comparison to Bayer ADVIA 2400: y = 0.94x + 0.25 R = 0.996 range from 4.3 to 117.3 mg/dL N = 143 | Serum: ADVIA 1650: y = 1.01x + 0.0, r = 1.000, N = 229, Range 5.1 -146.8 mg/dL Reference Method: y = 1.04x - 0.1, r = 0.997, N = 50, Range 5.5-136.2 mg/dL Urine: ADVIA 1650: y = 0.95x + 2.3, 0.995, N = 51, Range 76.0 - 982.0 mg/dL |
| Limitations | Lipemia: No interference up to 1000 mg/dL (10 g/l) Intralipid. Hemolysate: No interference up to 1000 mg/dl (10 g/l) hemoglobin. Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l). | Lipemia (from Intralipid): No significant interference up to 625 mg/dl of Intralipid. Hemolysate: No significant interference up to 525 mg/dl of hemoglobin. Bilirubin: No significant interference up to 30 mg/dl. |
Study Details to Prove Acceptance: Method Comparison Study
The primary study mentioned to demonstrate substantial equivalence and meet implied acceptance criteria is a method comparison study against the predicate device.
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Acceptance Criteria (Implied): The new device's results should correlate strongly with the predicate device, demonstrated by a regression equation (y = mx + b) where 'm' is close to 1, 'b' is close to 0, and the correlation coefficient 'R' (or 'r') is close to 1. Limitations should also be comparable or better.
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Study Description (New Device):
- Method Comparison: Comparison to Bayer ADVIA 2400.
- Regression Equation: y = 0.94x + 0.25 (where y is the new device and x is the predicate device).
- Correlation Coefficient: R = 0.996.
- Range: From 4.3 to 117.3 mg/dL.
- Sample Size: N = 143.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Types of Ground Truth: Not applicable in the traditional sense of expert consensus for imaging, as this is a quantitative chemical assay. The "ground truth" for the comparison is the measurement result from the predicate device (Bayer ADVIA 2400), which itself is established using a CDC reference method traceable to NIST materials.
- Training Set Sample Size & Ground Truth: Not applicable to this type of method comparison study for quantitative diagnostic devices. These devices are typically analytical rather than AI/machine learning driven, so "training sets" in that context are not relevant here.
Regarding other specific questions, based on the provided text:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: N = 143 for the method comparison study.
- Data Provenance: Not explicitly provided (e.g., country of origin, retrospective or prospective nature of the samples).
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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. For quantitative diagnostic assays like Urea/BUN, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by human expert consensus as might be the case for image-based diagnostics. The predicate device's results serve as the comparison point, traceable to NIST standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of quantitative diagnostic device. Adjudication methods are typically relevant for subjective assessments, like interpreting medical images.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This is a comparison between two quantitative diagnostic devices (the new device and a predicate device). MRMC studies are specific to evaluating human reader performance, often with and without AI assistance, typically in image interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself (Urea/BUN assay on the T60 instrument) operates in a standalone manner to produce a quantitative result. The method comparison study evaluates this standalone analytical performance against a comparator device. There is no "human-in-the-loop" aspect described for the assay's primary function.
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The type of ground truth used: The ground truth for the comparison is the measurement obtained from the predicate device (Bayer ADVIA 2400), which itself is stated to be traceable to the CDC reference method and uses NIST reference materials. This indicates a high-level analytical standard as the basis for comparison.
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The sample size for the training set: Not applicable for this type of device and study. These are chemical assays, not AI algorithms requiring a "training set" in the machine learning sense.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of an AI algorithm described here.
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(54 days)
Intended for the In Vitro, quantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers.
Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
This Reagent is intended for the in vitro quantitative determination of urea nitrogen in human serum.
This document is a 510(k) summary for a diagnostic reagent, not a study report for a medical device with an algorithm or AI. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and AI-specific details is not directly applicable or available in this type of submission.
However, I can extract the relevant information concerning the device's performance justification from the provided text, focusing on the concept of "substantial equivalence" as applicable to this type of device.
Key takeaway: The submission focuses on demonstrating "substantial equivalence" of the new reagent to legally marketed predicate devices, primarily through correlation studies comparing their performance on human serum samples. This is a common approach for in vitro diagnostic reagents where performance standards are often established by comparison to existing, accepted methods.
Here's an attempt to address the points based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Acceptable correlation/result comparisons with predicate devices on human serum. | "Correlation studies on human serum demonstrated acceptable result comparisons between these methods, which all use similar normal ranges." (Specific metrics like correlation coefficient, bias, or acceptable difference ranges are not provided in this summary). |
| Similar intended use to predicate devices. | "The JAS Urea Nitrogen (BUN) Liquid Reagent's intended use is identical to predicate Devices." |
| Acceptable performance on automated chemistry analyzers tested. | "its performance acceptable on the automated chemistry analyzers tested." (Specific analyzer types or performance metrics are not provided in this summary). |
| Similar normal ranges as predicate devices. | "Correlation studies... which all use similar normal ranges." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only states "human serum" was used for correlation studies.
- Data Provenance: Not specified (e.g., country of origin). The document implies the data was collected as part of the validation for this specific 510(k) submission.
- Retrospective or Prospective: Not specified, but typically, these correlation studies would be prospective or involve freshly collected samples for evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For a reagent comparing its performance to predicate reagents, "ground truth" is typically established by the results of the legally marketed predicate device(s) or an established reference method. There is no mention of "experts" in the sense of clinical reviewers establishing ground truth for individual cases. The expertise lies in the analytical method comparison.
4. Adjudication Method for the Test Set
- Not Applicable. There is no mention of an adjudication process as would be used for image interpretation or clinical diagnosis. The "adjudication" here is implied by the quantitative comparison of results between the new reagent and predicate reagents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not Applicable. This is a diagnostic reagent for quantitative measurement, not an AI-assisted device for human interpretation like an imaging algorithm. Therefore, an MRMC study is not relevant to this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a reagent. It performs its function (chemical reaction for quantitative measurement) independently once applied to the sample on an automated analyzer. There is no "algorithm" in the sense of AI or image processing. Its performance is inherently "standalone" in operating on the sample.
7. The Type of Ground Truth Used
- For this type of device, the "ground truth" (or reference standard) is implicitly the results obtained from the predicate devices (Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Mira analyzers and Pointe Scientific Urea Nitrogen (BUN) Reagent). The study aims to show that the new reagent's results align "acceptably" with these established methods.
8. The Sample Size for the Training Set
- Not Applicable. In the context of a diagnostic reagent, there is no "training set" in the sense of machine learning. The reagent's formulation and manufacturing process are developed through R&D, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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(17 days)
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(25 days)
For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Not Found
This document is a 510(k) clearance letter from the FDA for a diagnostic device called "Urea-L3K Assay." It states that the device is substantially equivalent to a legally marketed predicate device.
The letter itself does not contain details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. These are typically found in the 510(k) submission document itself, which is not provided here.
Therefore,Based on the provided document, the following information is not available:
- A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to a predicate device, but does not provide specific performance metrics or acceptance criteria it met.
- Sample size used for the test set and the data provenance: No information is given about the test set size or its origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: No details on adjudication are provided.
- 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 a diagnostic assay (chemical test), not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not applicable, and no information about it is present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is an assay, not an algorithm, this question is not applicable.
- The type of ground truth used: The document does not specify how ground truth was established for the studies supporting the submission. In the context of an assay for urea, the ground truth would typically be established by a reference method or validated primary method for measuring urea.
- The sample size for the training set: No information regarding a training set size is provided. This is a chemical assay, not typically an AI/ML model that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable, as detailed above.
The only relevant information directly from the document is related to the device and its intended use:
- Device Name: Urea-L3K Assay
- Regulatory Class: II
- Product Code: CDQ
- Indications for Use: For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
- Purpose of measurement: "Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases."
To obtain the detailed information requested, one would need to review the original 510(k) submission (K993178) filed by Diagnostics Chemicals Limited.
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(57 days)
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.
Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340/380 nm is proportional to the urea concentration in the sample.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Urea Nitrogen assay:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Urea Nitrogen assay focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific, prescriptive acceptance criteria. Substantial equivalence implies that the performance of the new device is comparable to the predicate such that it can be marketed for the same intended use without raising new questions of safety or effectiveness.
Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate similar performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Urea Nitrogen Assay) |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate | Serum: Correlation coefficient = 0.9974, slope = 1.038, Y-intercept = 0.904 mg/dL |
| Urine: Correlation coefficient = 0.9919, slope = 0.983, Y-intercept = 9.993 mg/dL | ||
| Precision | Acceptable precision (comparable to predicate) | Serum: Total %CV = 1.8% (Level 1), 2.0% (Level 2) |
| Urine: Total %CV = 3.8% (Level 1), 3.1% (Level 2) | ||
| Linearity/Assay Range | Acceptable linearity (comparable to predicate) | Serum: up to 234.4 mg/dL |
| Urine: up to 1,991.1 mg/dL | ||
| Limit of Quantitation (Sensitivity) | Acceptable sensitivity (comparable to predicate) | 0.9 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for the method comparison or precision studies.
- Data Provenance: Not specified. It's common for such studies to use human serum, plasma, or urine samples, but the country of origin or whether they were retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to in vitro diagnostic (IVD) assays that measure specific chemical analytes like urea nitrogen. The "ground truth" for these tests isn't established by expert consensus or interpretation of images, but rather by quantitative chemical methods. The comparison is made to a legally marketed predicate device, whose own performance characteristics (including accuracy against reference methods) would have been established previously.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative chemical assay, not one that involves human adjudication of diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a critical component, and the goal is to evaluate the impact of technology on reader performance. For a quantitative in vitro diagnostic assay, an MRMC study is not appropriate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance characteristics described (method comparison, precision, linearity, sensitivity) are for the "algorithm only" or the device in standalone mode, as it's an automated in vitro diagnostic assay. There is no human-in-the-loop component in the direct measurement process of this device.
7. The Type of Ground Truth Used
The "ground truth" for this comparative study is the results obtained from the legally marketed predicate device, the Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer. The new Urea Nitrogen assay's performance is compared directly against the results generated by this established predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a traditional in vitro diagnostic assay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" of the assay refers to its development and optimization by the manufacturer, but not through a data-driven machine learning process.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of machine learning for this device. The accuracy and performance of the assay would be established internally by the manufacturer during product development using various analytical methods and potentially reference materials, but these are distinct from "ground truth" for a machine learning training set.
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(28 days)
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.
Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLD), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.
The Abbott Laboratories Urea Nitrogen assay is an in vitro diagnostic device for the quantitative determination of urea nitrogen in human serum, plasma, or urine, used in the diagnosis and treatment of renal and metabolic diseases. It underwent a 510(k) submission to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly defined by demonstrating "acceptable correlation" in comparative performance studies and acceptable precision. The reported performance is as follows:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Serum Application) | Reported Device Performance (Urine Application) |
|---|---|---|---|
| Correlation Coefficient (vs Predicate) | Acceptable correlation | 0.9897 (vs Roche Cobas Mira Plus) | 0.9995 (vs Boehringer Mannheim) |
| Slope (vs Predicate) | Acceptable correlation | 0.963 (vs Roche Cobas Mira Plus) | 1.046 (vs Boehringer Mannheim) |
| Y-intercept (vs Predicate) | Acceptable correlation | 1.206 mg/dL (vs Roche Cobas Mira Plus) | -1.208 mg/dL (vs Boehringer Mannheim) |
| Total %CV (Level 1) | Acceptable precision | 4.9% | 3.0% |
| Total %CV (Level 2) | Acceptable precision | 3.9% | 3.3% |
| Linearity | Up to 120 mg/dL | Not specified for urine independently | |
| Limit of Quantitation (Sensitivity) | 1.8 mg/dL | Not specified for urine independently |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the comparative performance studies. It only states that "Comparative performance studies were conducted" and presents summary statistics (correlation coefficient, slope, Y-intercept).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a clinical chemistry assay, the data would typically be derived from laboratory tests, and the intent is for prospective clinical use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic assay where the "ground truth" is established by the comparative performance against legally marketed predicate devices using objective measurements, not by expert interpretation of images or other subjective assessments.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment to resolve discrepancies in expert opinions. This device's performance is assessed through quantitative comparisons with predicate devices.
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 standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool designed to aid human readers. Therefore, an MRMC study and
the concept of human reader improvement with AI assistance do not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The entire submission describes the performance of the Abbott Urea Nitrogen assay itself (the "algorithm only" in the context of an IVD) without human-in-the-loop performance modifications or assistance. Its performance characteristics (correlation, precision, linearity, sensitivity) were measured intrinsically and compared to predicate devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate devices:
- Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay (K954000) for the serum application.
- Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer (K771923) for the urine application.
These predicate devices are assumed to provide accurate measurements of urea nitrogen, serving as the reference for determining the substantial equivalence of the new device.
8. The Sample Size for the Training Set
Not applicable. This is a traditional in vitro diagnostic assay, not a machine learning or AI-based device that requires a distinct "training set" in the conventional sense. The development of such an assay involves reagent formulation, instrument calibration, and optimization based on chemical principles and experimental data, rather than training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" in the context of this traditional IVD development. The "ground truth" in the development of such assays is based on established analytical chemistry principles, reference methods, and quality control materials.
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(21 days)
For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.
Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method
This document is a 510(k) clearance letter from the FDA for a Urea Nitrogen (BUN) Liquid Reagent Set. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of device performance as typically discussed for AI/ML-driven medical devices. Instead, it focuses on the regulatory clearance process for an in vitro diagnostic reagent set.
Therefore, I cannot provide the requested information for the following reasons:
- No acceptance criteria: The letter itself does not state specific performance acceptance criteria for the reagent set. It refers to the device being "substantially equivalent" to predicate devices, implying that its performance is comparable, but doesn't quantify specific metrics like sensitivity, specificity, or accuracy targets.
- No study details: The letter does not describe any specific study conducted to demonstrate the device's performance against detailed acceptance criteria. It's a regulatory clearance, not a clinical or performance study report.
- Nature of the device: This is a diagnostic reagent set, not an AI/ML-driven device that would typically involve test sets, ground truth derived from experts, MRMC studies, or standalone algorithm performance.
The "study" referenced in the context of this document is the 510(k) submission itself, where the manufacturer provides data (e.g., analytical performance, comparison to predicate) to demonstrate substantial equivalence, but the details of such a study are not included in this FDA clearance letter.
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(40 days)
For the quantitative determination of urea in serum. For IN VITRO diagnostic use. The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Serum urea plays an important role in the discrimination between prerenal and postrenal azotemia.
Not Found
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance of the Urea-SL Assay device. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not contain the specific technical or clinical study data requested.
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(115 days)
The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "UREA reagent (BUN)". This document is a regulatory approval and does not contain details about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory information, but it does not describe clinical or performance study results.
Therefore, I cannot provide the requested information based on the provided text.
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