(131 days)
The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF). The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 nm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.
Here's a summary of the acceptance criteria and study details for the Urine/CSF Protein assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance (UPro on AEROSET) |
|---|---|---|
| Method Comparison (Correlation) | Acceptable correlation with predicate device (Boehringer Mannheim Urinary/CSF Protein on Hitachi 717 Analyzer). Implicitly, this means high correlation coefficients and slopes close to 1 with Y-intercepts close to 0. | Urine Application: Correlation Coefficient = 0.992, Slope = 1.065, Y-intercept = -0.264 mg/dL |
| CSF Application: Correlation Coefficient = 0.9965, Slope = 0.985, Y-intercept = 5.762 mg/dL | ||
| Precision | Acceptable within-run, between-run, and between-day precision for control materials. Implicitly, low %CV values. | Urine Application (Total %CV): Level 1/Panel 201 = 4.8%, Level 2/Panel 202 = 2.5% |
| CSF Application (Total %CV): Level 1/Panel 301 = 2.4%, Level 2/Panel 302 = 1.5% | ||
| Linearity | Linearity over a clinically relevant range. | Linear up to 200 mg/dL |
| Limit of Quantitation (Sensitivity) | Clinically acceptable limit for detection and quantification. | 4.8 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies.
- The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is implied to be clinical samples since it refers to "human urine or cerebrospinal fluid."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as the study involves a comparative performance analysis against a legally marketed predicate device (Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer), not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is effectively the results obtained from the predicate device.
4. Adjudication Method for the Test Set:
- Not applicable, as this is a performance comparison of an in vitro diagnostic assay against a predicate device, not a study involving expert interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This device is an in vitro diagnostic assay, not an imaging or interpretive device that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, the performance characteristics (method comparison, precision, linearity, sensitivity) are presented as standalone performance of the UPro assay on the AEROSET system. There is no human interaction described in the performance evaluation of the device itself.
7. The Type of Ground Truth Used:
- The "ground truth" for evaluating the UPro assay was established by comparison to a legally marketed predicate device, the Boehringer Mannheim Urinary/CSF Protein assay on the Hitachi 717 Analyzer. The performance of the predicate device serves as the reference standard.
8. The Sample Size for the Training Set:
- The document does not provide information about a training set. As an in vitro diagnostic assay, the "training" would typically refer to the development and optimization of the reagent and assay protocol, rather than a machine learning training set with a specific sample size.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the context of this traditional in vitro diagnostic assay. The ground truth for development and optimization would have been based on established analytical chemistry principles and potentially reference methods, but this type of detail is not typically included in a 510(k) summary.
§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.