(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.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.