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510(k) Data Aggregation
(524 days)
CDQ
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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CDQ
The BS-480/BS-490/CLC7201 chemistry analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney functions and other diseases associated with protein catabolism.
The BS-480/BS-490/CLC72i Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The UREA was cleared under K971309 and is the chosen assay to demonstrate performance for the photometric unit. The BS-480 Chemistry Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured according to your request:
Description of the Device and Study:
The BS-480/BS-490/CLC720i Chemistry Analyzer is an automated clinical chemistry analyzer designed for in vitro photometric assays and includes an optional Ion-Selective Electrode (ISE) module. It measures Na+, K+, Cl- in serum, plasma, and urine samples, and Urea Nitrogen (BUN) in serum samples.
The study aimed to demonstrate substantial equivalence to the predicate device, the BS-400 Chemistry Analyzer (K112377). This was achieved by evaluating the performance of the BS-480, including its ISE module, across various metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the performance metrics. Instead, it presents the performance characteristics of the BS-480 Chemistry Analyzer. For comparison, the correlation analysis refers to the BS-400 as the predicate, implying that performance should be comparable to or better than the predicate.
Below, I will list the performance data presented, which implicitly served as the "reported device performance" and was deemed acceptable for substantial equivalence.
Performance Characteristics of BS-480 Chemistry Analyzer
| Metric | Analyte | Unit | Reported Performance |
|---|---|---|---|
| Correlation Analysis | BUN | mg/dL | Slope: 0.9912, Intercept: 0.0494, Correlation Coefficient: 1.000 (Sample Range: 5.7-147.4, N=120) |
| (vs BS-400) | Serum Na+ | mmol/L | Slope: 0.9613, Intercept: 3.243, Correlation Coefficient: 0.998 (Sample Range: 101.3-197.1, N=132) |
| Serum K+ | mmol/L | Slope: 0.9570, Intercept: 0.0914, Correlation Coefficient: 1.000 (Sample Range: 1.35-7.34, N=120) | |
| Serum Cl- | mmol/L | Slope: 0.9537, Intercept: 4.216, Correlation Coefficient: 0.998 (Sample Range: 54.7-147, N=125) | |
| Urine Na+ | mmol/L | Slope: 0.9925, Intercept: -0.9291, Correlation Coefficient: 1.000 (Sample Range: 12-473, N=120) | |
| Urine K+ | mmol/L | Slope: 0.9677, Intercept: 0.6774, Correlation Coefficient: 1.000 (Sample Range: 5-192, N=120) | |
| Urine Cl- | mmol/L | Slope: 1.006, Intercept: 2.704, Correlation Coefficient: 1.000 (Sample Range: 16-396, N=120) | |
| Bias at Medical Decision Points | BUN | mg/dL | Point 1 (6): 0.00/-0.1%; Point 2 (26): -0.18/-0.7%; Point 3 (50): -0.39/-0.8% |
| Serum Na+ | mmol/L | Point 1 (115): -1.26/-1.1%; Point 2 (135): -2.0/-1.5%; Point 3 (150): -2.55/-1.7% | |
| Serum K+ | mmol/L | Point 1 (3.0): -0.038/-1.3%; Point 2 (5.8): -0.158/-2.7%; Point 3 (7.5): -2.31/-3.1% | |
| Serum Cl- | mmol/L | Point 1 (90): 0.05/0.1%; Point 2 (112): -0.97/-0.9% | |
| Urine Na+ | mmol/L | Point 1 (40): -1.2/-3.1%; Point 2 (112): -2.6/-1.2% | |
| Urine K+ | mmol/L | Point 1 (25): -0.1/-0.5%; Point 2 (125): -3.4/-2.7% | |
| Urine Cl- | mmol/L | Point 1 (110): 3.4/3.1%; Point 2 (250): 4.2/1.7% | |
| Preliminary Precision | BUN | mg/dL | CV% range: 0.4% - 1.0% across 6 pools |
| (Repeatability) | Serum Na+ | mmol/L | CV% range: 0.2% - 0.6% across 6 pools |
| Serum K+ | mmol/L | CV% range: 0.2% - 0.4% across 6 pools | |
| Serum Cl- | mmol/L | CV% range: 0.2% - 0.6% across 5 patient pools | |
| Urine Na+ | mmol/L | CV% range: 0.2% - 1.3% across 4 pools | |
| Urine K+ | mmol/L | CV% range: 0.0% - 1.3% across 4 pools | |
| Urine Cl- | mmol/L | CV% range: 0.4% - 1.5% across 4 pools | |
| Total Precision | BUN | mg/dL | Repeatability CV% range: 0.4% - 0.7%; Within-Device Precision CV% range: 1.7% - 1.8% (3 control pools, n=80 per pool) |
| Serum Na+ | mmol/L | Repeatability CV% range: 0.2% - 0.4%; Within-Device Precision CV% range: 0.6% - 0.8% (3 control pools, n=80 per pool) | |
| Serum K+ | mmol/L | Repeatability CV% range: 0.3% - 0.4%; Within-Device Precision CV% range: 0.7% - 0.9% (3 control pools, n=80 per pool) | |
| Serum Cl- | mmol/L | Repeatability CV% range: 0.3% - 0.5%; Within-Device Precision CV% range: 0.7% - 0.9% (3 control pools, n=80 per pool) | |
| Urine Na+ | mmol/L | Repeatability CV% range: 1.1% - 1.7%; Within-Device Precision CV% range: 1.8% - 2.9% (2 control pools, n=80 per pool) | |
| Urine K+ | mmol/L | Repeatability CV% range: 0.3% - 0.5%; Within-Device Precision CV% range: 0.8% - 1.5% (2 control pools, n=80 per pool) | |
| Urine Cl- | mmol/L | Repeatability CV% range: 0.6% - 1.2%; Within-Device Precision CV% range: 1.1% - 2.7% (2 control pools, n=80 per pool) | |
| Linearity | BUN | mg/dL | Slope: 1.0000, Intercept: -0.0109, Correlation Coefficient: 0.9992 (Tested Range: 5.1-165.1, Claimed Range: 5.5-151.7) |
| Serum Na+ | mmol/L | Slope: 1.0001, Intercept: -0.0073, Correlation Coefficient: 0.9999 (Tested Range: 69.1-250.2, Claimed Range: 100-200) | |
| Serum K+ | mmol/L | Slope: 1.0001, Intercept: -0.0005, Correlation Coefficient: 0.9998 (Tested Range: 0.85-9.76, Claimed Range: 1-8) | |
| Serum Cl- | mmol/L | Slope: 0.9999, Intercept: -0.0126, Correlation Coefficient: 0.9999 (Tested Range: 44.7-186.1, Claimed Range: 50-150) | |
| Urine Na+ | mmol/L | Slope: 1.0001, Intercept: -0.0461, Correlation Coefficient: 1.0000 (Tested Range: 10-614, Claimed Range: 10-500) | |
| Urine K+ | mmol/L | Slope: 1.0005, Intercept: -0.2565, Correlation Coefficient: 0.9997 (Tested Range: 4-230, Claimed Range: 5-200) | |
| Urine Cl- | mmol/L | Slope: 1.0000, Intercept: -0.2015, Correlation Coefficient: 0.9996 (Tested Range: 7-452, Claimed Range: 15-400) | |
| Detection Limits | BUN | mg/dL | LoB: 0.2, LoD: 0.3, LoQ: 4.8 |
| Serum Na+ | mmol/L | LoB: 3.7, LoD: 5.1, LoQ: 48.0 | |
| Serum K+ | mmol/L | LoB: 0.21, LoD: 0.24, LoQ: 0.69 | |
| Serum Cl- | mmol/L | LoB: 1.2, LoD: 3.7, LoQ: 36.6 | |
| Urine Na+ | mmol/L | LoB: 3, LoD: 4.5, LoQ: 10 | |
| Urine K+ | mmol/L | LoB: 1, LoD: 1.2, LoQ: 3.3 | |
| Urine Cl- | mmol/L | LoB: 1, LoD: 2.6, LoQ: 6.3 | |
| Interference (NSI) | BUN | mg/dL | Bilirubin: |
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(42 days)
CDQ
EasyRA BUN Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. EasyRA CREA Reagent: The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.
Not Found
This is a 510(k) premarket notification for in vitro diagnostic reagents, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design for AI performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document. The document primarily focuses on establishing substantial equivalence for the EasyRA BUN Reagent and EasyRA CREA Reagent to predicate devices.
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(188 days)
CDQ
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:
-
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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(269 days)
CDQ
ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided 510(k) summary describes the acceptance criteria and performance study for the ABX PENTRA Urea CP reagent (for urine samples) and ABX PENTRA Urine Control L/H.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: ABX PENTRA Urea CP (for urine samples)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection Limit | Urea: 12.6 mmol/l |
| BUN: 35 mg/dl | |
| Accuracy and Precision | CV Total |
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(69 days)
CDQ
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma.
This reagent set is intended for in vitro diagnostic use only.
The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose.
The provided text describes the acceptance criteria and performance of the "Teco CX3 Reagent Set for SYNCHRON CX System" for the quantitative determination of BUN, Calcium, Creatinine, and Glucose in serum. The study is a method comparison and precision evaluation against predicate devices, following NCCLS guidelines. It is a standalone performance study of a diagnostic reagent set.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Feature/Analyte | Acceptance Criteria (Candidate Device) | Reported Device Performance (Teco CX3 Reagent Set) |
|---|---|---|
| BUN | Precision: CV% within 8% | Within-Day CV%: Sample 1: 2.5%, Sample 2: 1.9%, Sample 3: 1.3% |
| Day to Day CV%: Sample 1: 2.0%, Sample 2: 2.0%, Sample 3: 1.1% | ||
| Accuracy: r > 0.95; Slope: 0.97-1.1 | Accuracy: R=0.99, Y=1.00-0.911 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 3 to 102 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 15-39 mg/dL | |
| Calcium | Precision: CV% within 5% | Within-Day CV%: Sample 1: 0.9%, Sample 2: 0.9%, Sample 3: 0.8% |
| Day to Day CV%: Sample 1: 1.0%, Sample 2: 1.1%, Sample 3: 1.0% | ||
| Accuracy: r > 0.90; Slope: 0.90-1.1 | Accuracy: R=0.96, Y=1.07X+0.60 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 1.0 to 15 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 8.4-10.2 mg/dL | |
| Creatinine | Precision: CV% within 10% | Within-Day CV%: Sample 1: 2.7%, Sample 2: 1.6%, Sample 3: 1.7% |
| Day to Day CV%: Sample 1: 2.2%, Sample 2: 3.7%, Sample 3: 1.6% | ||
| Accuracy: r > 0.96; Slope: 0.90-1.1 | Accuracy: R=0.99, Y=0.97-0.11 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 0.2 to 24 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 0.6-1.3 mg/dL | |
| Glucose | Precision: CV% within 10% | Within-Day CV%: Sample 1: 2.5%, Sample 2: 1.3%, Sample 3: 1.5% |
| Day to Day CV%: Sample 1: 3.3%, Sample 2: 2.2%, Sample 3: 1.2% | ||
| Accuracy: r > 0.90; Slope: 0.85-1.1 | Accuracy: R=0.99, Y=0.96X+0.36 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 30 to 750 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 70-105 mg/dL |
2. Sample size used for the test set and the data provenance
- Sample Size for Precision (Test Set): For the candidate device, N=25 for each of the three samples tested for within-day and day-to-day precision for BUN, Calcium, Creatinine, and Glucose.
- Sample Size for Accuracy/Linearity (Test Set): Not explicitly stated as a separate sample size for accuracy/linearity, but these tests typically use a series of patient samples and/or spiked samples. The "Method Comparison and Bias Estimation Using Patient Samples" (NCCLS EP9-A2) guideline was followed, indicating the use of patient samples.
- Data Provenance: The study used "Human Serum". The country of origin for the data is not specified in the provided text. It is a retrospective evaluation of the performance of the reagent set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a chemical assay study for quantitative determination of analytes. The "ground truth" is established by the analytical method itself and comparison to a predicate device. There is no mention of human experts interpreting results to establish ground truth in the context of this study.
4. Adjudication method for the test set
Not applicable. This is a quantitative chemical assay comparison, not an imaging or qualitative diagnostic study requiring 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 a study of an in vitro diagnostic reagent set, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Teco CX3 Reagent Set for SYNCHRON CX System" is a standalone diagnostic reagent set designed for use on an automated analyzer (Beckman CX3 System). Its performance (precision, linearity, accuracy) was evaluated independently of human interpretation of the results, beyond the standard operation of the analytical system.
7. The type of ground truth used
The ground truth is established by:
- Predicate Device Comparison: The candidate device's performance is compared against legally marketed predicate devices (Teco BUN Liquid, Teco Calcium Color, Teco Creatinine, and Teco Glucose Liquid Reagent).
- Analytical Standards: Linearity and accuracy are typically assessed against known concentrations of calibrators or reference materials.
- Statistical Analysis: Precision is measured through statistical analysis of replicate measurements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set" in the conventional sense. The development of the reagent set would involve internal validation and formulation, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device. The formulation and quality control of the reagents during manufacturing would ensure their performance, but this is a different concept from establishing ground truth for a machine learning model.
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(72 days)
CDQ
This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction.
This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Urea Nitrogen (BUN) test system
The provided document is a 510(k) clearance letter from the FDA for a Urea Nitrogen (BUN) test system. It does not contain information regarding detailed acceptance criteria, device performance studies, or specifics about a test set (like sample size, data provenance, expert consensus, etc.).
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. The specific performance data and study details requested are typically found in the 510(k) submission itself, not in the clearance letter.
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CDQ
The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.
The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.
The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.
However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."
| Performance Metric | Acceptance Criteria (Implied/Referenced) | Reported Device Performance |
|---|---|---|
| Imprecision | Acceptable/equivalent results (Implied) | Serum controls give acceptable/equivalent results using the described procedure for within run and total imprecision with each of the representative test methods (Synermed, Medical Analysis Systems, and STANBIO Laboratory Reagents, as shown in Table 1 and Table 2 vs insert values). |
| Correlation | Acceptable results (Implied) | Slopes, Intercepts and Correlation Coefficients show acceptable results. The regression (slope and intercept) and correlation coefficients are shown in Table 3 and Graphs 1-21. Acceptable results are shown between both methods (STANBIO Laboratory Reagents vs. Synermeds® or Medical Analysis Systems Reagents). |
| Linearity | Not exceeding Manufacturers' claim | Linearity did not exceed the Manufacturers' claim (shown in Table 4 vs insert values). A comparison is made between STANBIO Laboratory Reagents and the Least Square line to establish linearity. |
| Recovery | Acceptable results for assigned ranges | Acceptable results are shown between both methods (using assigned control serums ranges, shown in Table 5). |
| Normal Range | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
| Sensitivity | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
| Stability | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
2. Sample Size Used for the Test Set and Data Provenance:
- Imprecision: Two control serums were used for both within-run and total precision.
- Within-run: Up to 20 repeats.
- Total precision: Duplicates for up to 20 days.
- Correlation: "about 100 serums" were used.
- Linearity: "Commercially available linearity material" was assayed.
- Recovery: "Commercial available Controls with assigned values" were used.
Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.
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 as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established by:
- Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
- Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.
This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.
8. The Sample Size for the Training Set:
This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).
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(71 days)
CDQ
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 |
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(63 days)
CDQ
This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen (BUN) in serum or plasma. For in vitro diagnostic use only.
Not Found
The provided text is a 510(k) clearance letter for a medical device (Raichem® BUN Rate Reagent) and its indications for use. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study. These details are typically found in the 510(k) submission summary or the full submission, not in the clearance letter itself.
Therefore, I cannot provide the requested table and study details based on the given input. The document focuses on regulatory approval rather than the technical performance evaluation study.
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