(134 days)
In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders.
Protein measurements in urine are 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.
CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems.
C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.
The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid.
Here's a breakdown of the acceptance criteria and study information for the Total Protein Urine/CSF Gen. 3 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it compares the performance of the modified device (Total Protein Urine/CSF Gen. 3 on COBAS INTEGRA and Roche/Hitachi platforms) against its predicate device (Roche/Hitachi Total Protein Urine/CSF K913615) for various features. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device, meaning the new device performs as well as or better than the predicate for key parameters.
Here's a table summarizing the reported device performance, with the understanding that for most parameters, the 'acceptance' is that the modified device's performance aligns with or improves upon the predicate.
| Feature | Predicate Device Performance (Roche/Hitachi Total Protein Urine/CSF K913615) | Modified Device Performance (Total Protein Urine/CSF Gen. 3) |
|---|---|---|
| Intended Use/Indications for Use | In vitro test for quantitative determination of protein in urine (U) and CSF | Same |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Same |
| Test Principle | Turbidimetric | Same |
| Reagent Composition | R1: Sodium hydroxide 530 mmol/L, EDTA sodium, 74 mmol/L; R2=SR: Benzethonium chloride 32 mmol/L | Same |
| Stability (Shelf-life) | 20-25 °C until expiration date | Roche/Hitachi: 15-25 °C until expiration date |
| Stability (On-board) | R1: 3 weeks on board at 2-12 °C; R2: 3 weeks on board at 2-12 °C | Roche/Hitachi: R1: 21 days on board and refrigerated; R2: 21 days on board and refrigerated |
| COBAS INTEGRA 400/400 plus: 12 weeks on board at 10 to 15°C | ||
| COBAS INTEGRA 700/800 plus: 6 weeks on board at 10 to 15°C | ||
| Quality Control | Commercially available urine and CSF protein controls | Roche/Hitachi: Same |
| COBAS INTEGRA: Same | ||
| Traceability | Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method. | Same |
| Precision (Urine - Within Run) | 2.25% @ 17.9 mg/dL; 0.5% @ 102.2 mg/dL | Roche/Hitachi: 1.9% @ 21 mg/dL; 1.0% @ 67.3 mg/dL |
| COBAS INTEGRA: 2.8%@ 89 mg/L; 1.4% @ 227 mg/L; 0.4% @ 616 mg/L | ||
| Precision (Urine - Total/Between day) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL | Roche/Hitachi: 1.7% @ 34.5 mg/dL; 1.1% @ 114.37 mg/dL |
| COBAS INTEGRA: 1.3% @ 91 mg/L; 1.0% @ 229 mg/L; 0.6% @ 613 mg/L | ||
| Precision (CSF - Within Run) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL * (Listed as Urine, likely a typo) | Roche/Hitachi: 0.9% @ 23.1 mg/dL; 0.7% @ 53.6 mg/dL |
| COBAS INTEGRA: 0.5% @ 345 mg/L; 0.3% @ 867 mg/L | ||
| Precision (CSF - Total/Between day) | 1.9% @ 18.1 mg/dL; 1.03% @ 102.4 mg/dL | Roche/Hitachi: 1.0% @ 29.3 mg/dL; 0.6% @ 90.2 mg/dL |
| COBAS INTEGRA: 0.9% @ 346 mg/L; 0.6% @ 867 mg/L | ||
| Measuring Range (Linearity) | Analyzer specific linearity claims: 2-200 mg/dL (Hitachi 717) | Roche/Hitachi: 2-200 mg/dl (20-2000 mg/l) with dilution capability |
| COBAS INTEGRA: 40-2000 mg/L (Extended to 40-6000 mg/L with post dilution factor of 3) | ||
| Lower Detection Limit | Not specified | Roche/Hitachi: 20 mg/L |
| COBAS INTEGRA: 40 mg/L | ||
| Expected Values | Urine 24h: |
§ 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.