(31 days)
In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
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 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 conditions such as meningitis, brain tumors and infections of the central nervous systems.
The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.
Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.
| Feature / Criteria | Predicate Device Performance (Endpoint Assay, K913615) | Modified Device Performance (Rate Application) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Intended Use | For the quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF). | In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. | Maintain intended use of predicate. |
| Specimen | Urine and CSF | Same | Same specimen types as predicate. |
| Application | Endpoint assay | Endpoint and Rate application | New rate application should be equivalent to or improve upon endpoint. |
| Measuring Range (Urine) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Measuring Range (CSF) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Lower Detection Limit (Urine) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Lower Detection Limit (CSF) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Expected Values | Urine Random: |
§ 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.