VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208

K063591 · Ortho-Clinical Diagnostics, Inc. · JFY · Dec 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063591
• Device Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, LI, Mg, PHOS, SALI, THEO, and URIC.

Device Story

Vitros Chemistry Products Calibrator Kit 1; used for calibration of Vitros Chemistry Systems. Modification involves change in traceability method for creatinine value assignment to GC-IDMS (Gas Chromatography-Isotope Dilution Mass Spectrometry) reference method. Device remains substantially equivalent to previously cleared version; fundamental scientific technology unchanged.

Clinical Evidence

Bench testing only; design control activities and verification/validation performed to confirm impact of traceability method change.

Technological Characteristics

Multilayered analytical slide on polyester support. Principle: two-point colorimetric rate. Instrumentation: VITROS Chemistry Systems. Calibration: traceable to GC/IDMS and NIST SRM 914. Software: two-point rate math model.

Indications for Use

Indicated for patients requiring creatinine measurement for diagnosis/treatment of renal disease or monitoring renal dialysis. Applicable to serum, plasma, and urine samples.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Vitros Chemistry Products Calibrator Kit 1 (K001310)

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 K063591

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.) k001310
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 a change in the traceability method to the GC-IDMS (Gas Chromatography-Isotope Dilution Mass Spectrometry) reference method for the value assignment of creatinine in Vitros Chemistry Products Calibrator Kit 1.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Labeling changes were made in association with the above modification in the calibration section, expected value section 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
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.

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