TOTAL PROTEIN URINE/CSF GEN.3

K071239 · Roche Diagnostics · JGQ · Sep 14, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071239
• Device Name: TOTAL PROTEIN URINE/CSF GEN.3
• Applicant: Roche Diagnostics
• Product Code: JGQ · Clinical Chemistry
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1635
• Device Class: Class 2

Indications for Use

The Urinary/CSF Protein reagent is intended for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF) on the COBAS Integra 400/700/800 analyzers.

Device Story

In vitro diagnostic reagent for quantitative protein measurement in urine and CSF; utilizes turbidimetric endpoint assay; operates on COBAS INTEGRA and Roche/Hitachi analyzer platforms. Input: patient urine or CSF samples; Output: protein concentration (mg/dL or mg/L). Used in clinical laboratories by trained technicians. Results assist physicians in diagnosing renal, heart, thyroid, and CNS disorders. Benefits include automated, standardized protein quantification for clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance of the modified reagent application and automated dilution system.

Technological Characteristics

Turbidimetric endpoint assay. Reagents: R1 (Sodium hydroxide 530 mmol/L, EDTA sodium 74 mmol/L), R2 (Benzethonium chloride 32 mmol/L). Traceable to NIST SRM 927. Automated analyzer-based. Measuring range: 40-2000 mg/L (extended to 6000 mg/L).

Indications for Use

Indicated for quantitative determination of total protein in urine and CSF to aid in diagnosis/treatment of renal, heart, thyroid, liver, kidney, bone marrow, metabolic, or nutritional disorders, and CNS infections/tumors. For prescription use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Roche/Hitachi Total Protein Urine/CSF (K913615)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k071239

This 510(k) submission contains information/data on modifications made to the SUBMITTERS own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTERS previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k913615 Roche Diagnostics Hitachi Urinary/CSF Protein Assay (formerly Boehringer Mannheim).

2. Submitters statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, users and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the application of the Urinary/CSF Protein reagent on the COBAS Integra 400/700/800 analyzers and the introduction of a single level calibrator (200 mg/L) that is automatically diluted by the instrument; the dilution ratios for this calibrator are: 1:1, 1:4, 1:20, and 1:40.

4. Comparison Information (similarities and differences) to applicants legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis: FMEA
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

REVISED: 3/14/95