TOTAL PROTEIN URINE/CSF GEN.3

K141925 · Roche Diagnostics Operations (Rdo) · JIQ · Dec 9, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141925
• Device Name: TOTAL PROTEIN URINE/CSF GEN.3
• Applicant: Roche Diagnostics Operations (Rdo)
• Product Code: JIQ · Clinical Chemistry
• Decision Date: Dec 9, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Indications for Use

The Total protein Urine/CSF Gen.3 is an in vitro test for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF) on Roche/Hitachi cobas c systems.

Device Story

TPUC3 Total Protein Urine/CSF Gen.3 is an in vitro diagnostic assay for quantitative protein measurement in human urine and CSF. Used on Roche COBAS Integra 400 plus analyzer; operates via turbidimetric method. Reagents (Sodium Hydroxide, EDTA-Na, Benzethonium chloride) react with protein samples to produce turbidity proportional to protein concentration. Analyzer measures turbidity; results provided to clinicians for diagnosis/treatment of renal, heart, thyroid, or CNS disorders. Modification adds interference limitations for radiopaque media (>6.4 g/L organically bound iodine) and homogentisic acid (>1.2 mmol/L). No high-dose hook effect up to 100 g/L. Benefits include accurate protein quantification to support clinical decision-making in disease management.

Clinical Evidence

Bench testing only. Verification and validation activities focused on interference testing for organically bound iodine, homogentisic acid, and hook effect to support updated labeling.

Technological Characteristics

Turbidimetric assay; reagents include Sodium Hydroxide (677 mmol/L), EDTA-Na (74 mmol/L), and Benzethonium chloride (32 mmol/L). Designed for use on COBAS Integra 400 plus analyzer. Measuring range 40-2000 mg/L. Standardized against NIST SRM-927. Connectivity via automated analyzer platform.

Indications for Use

Indicated for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF) for diagnostic purposes.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) 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.

Predicate Devices

• Total protein Urine/CSF Gen.3 (K071239)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Summary (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: K141925

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S 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 SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K071239, Total protein Urine/CSF Gen.3

2. Submitter's 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, user's 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 addition of new interference information: Three new interferents – organically bound iodine from radiopaque media, homogentisic acid and hook effect were added.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, 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

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

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 (or their preamendment) device.