PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

K050026 · Roche Diagnostics · JIX · Jan 31, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050026
• Device Name: PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
• Applicant: Roche Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Device Story

Modified Precipath/Precinorm Proteins in Urine control and C.f.a.s. PUC calibrator; modification involves addition of Immunoglobulin G (IgG) constituent to existing formulations. Device used in clinical laboratory settings to monitor assay performance and calibrate protein measurements in urine. Modification verified via risk analysis (FMEA) and design control activities to ensure fundamental scientific technology remains unchanged. Output consists of standardized control/calibration values for clinical chemistry analyzers.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

In vitro diagnostic control and calibrator materials. Modification consists of adding Immunoglobulin G (IgG) to existing liquid/lyophilized formulations. Fundamental scientific technology remains consistent with previously cleared predicates. Compliance with 21 CFR 820.30 design controls.

Indications for Use

Indicated for use as a calibrator (C.f.a.s. PUC) or quality control material (Precinorm/Precipath PUC) for quantitative Roche clinical chemistry methods measuring proteins in urine or cerebrospinal fluid (CSF).

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

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 the limitations in § 862.9.

Predicate Devices

• K040264
• K040280
• K041812

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 K050026

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.)
Predicates: K040264,K040280, K041812

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: The addition of Immunoglobulin G constituent to the previously cleared Precipath/Precinorm® Proteins in Urine control and the addition of Immunoglobulin G constituent to the previously cleared C.f.a.s. PUC calibrator. The applicant modified their labels and value sheets to reflect this addition.

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

4. 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
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.

5. 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 (or their preamendment) device.

Comments:

The modifications of the Precinorm, Precipath (Class I control), and C.f.a.s PUC (Class II calibrator) do not affect the intended use or indications for use of the device as described in the device labeling. The modifications do not alter the scientific technology underlying the device as demonstrated by a risk analysis (FMEA) and meets predetermined acceptance criteria.

revised:8/1/03