ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

K072638 · Roche Diagnostics Corp. · JGQ · Oct 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072638
• Device Name: ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
• Applicant: Roche Diagnostics Corp.
• Product Code: JGQ · Clinical Chemistry
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1635
• Device Class: Class 2

Indications for Use

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.

Device Story

In vitro diagnostic reagent for quantitative total protein measurement in urine and CSF; used on Roche/Hitachi analyzers. Modification introduces kinetic (rate) assay method alongside existing endpoint assay. Device processes patient samples via automated analyzer; measures protein concentration; provides quantitative results to clinicians for diagnostic assessment. Operates in clinical laboratory settings; managed by laboratory technicians/pathologists. Output informs clinical decision-making regarding renal function or neurological status.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance of the new kinetic assay method against established acceptance criteria.

Technological Characteristics

Turbidimetric assay; Reagent R1: Sodium hydroxide (530 mmol/L), EDTA sodium (74 mmol/L); Reagent R2: Benzethonium chloride (32 mmol/L). Automated clinical chemistry analyzer platform. Measuring range: 6-200 mg/dL (rate assay). Standardized against National Bureau of Standards SRM 927a (biuret method).

Indications for Use

Indicated for quantitative protein determination in urine and cerebrospinal fluid to aid in the diagnosis and treatment of diseases involving the liver, kidney, bone marrow, metabolic or nutritional disorders, renal or heart diseases, thyroid disorders, meningitis, brain tumors, and central nervous system infections.

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 Urinary/CSF Protein (K913615)

Submission Summary (Full Text)

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

To: THE FILE
RE: DOCUMENT NUMBER k072638

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 introduction of the rate (kinetic) assay in addition to the cleared endpoint assay for the Urinary/CSF Protein reagent on the Roche/Hitachi Analyzers.

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.