MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

K042389 · Roche Diagnostics Corp. · JJY · Sep 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042389
• Device Name: MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet

Device Story

Precinorm U Plus and Precipath U Plus are lyophilized human serum-based quality control products. They contain added constituents adjusted to represent normal and pathological ranges for various analytes, including enzymes, proteins, and substrates. The device is used in clinical laboratories by laboratory technicians or clinicians to monitor the accuracy and precision of quantitative analytical methods, both manual and automated. By comparing measured values against the provided value sheet, users verify the performance of their clinical chemistry analyzers. This monitoring ensures the reliability of patient test results, aiding in accurate clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control. Contains biological additives including recombinant human lipase and bovine-derived albumin/protein (for Precinorm U Plus). Stability specifications defined for reconstituted serum at various temperatures (-25°C to 25°C).

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and precision of quantitative laboratory methods for substrates, electrolytes, lipids, enzymes, proteins, and selected drugs in human serum samples.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

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 K_042389

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.)
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.
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 changes in the analyte source of the lipase to human pancreas from porcine pancreas, a change in the analyte source of the albumin and total protein from human serum to bovine plasma, addition of the stabilizing agent Progallin to increase bilirubin stability, and a change in the raw material source to increase the stability for inorganic phosphorous.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Labelling changes were made in association with the above listed modification as well as other editorial changes including – layout rearrangement and rewording of “Assigned values and ranges section as “target Values and ranges”, Modification of the wording of the intended use statement, changes to the global material number, and changes to the formatting of storage temperature ranges and time periods.

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
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 (or their preamendment) device.