VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927

K071215 · Ortho-Clinical Diagnostics, Inc. · JFY · May 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071215
• Device Name: VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS Chemistry Products urCR DT Slides quantitatively measure creatinine concentration in urine on the DT60/DT60 II analyzer. 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 Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Story

VITROS urCR DT Slides are multilayered analytical elements on polyester support for quantitative creatinine measurement in urine. Sample deposited on slide; distributed by spreading layer; creatinine hydrolyzed to creatine; converted to sarcosine and urea; sarcosine oxidized to glycine, formaldehyde, and hydrogen peroxide; peroxidase-catalyzed oxidation of leuco dye produces colored product. System measures rate of change in reflection density proportional to creatinine concentration. Used on VITROS DT60/DT60II Chemistry Systems in clinical settings. Healthcare providers use results to diagnose/monitor renal disease and dialysis. Calibrator kit uses lyophilized standards from processed bovine serum to calibrate systems.

Clinical Evidence

Bench testing only. Evidence includes linearity, limit of detection (LOD), and limit of quantitation (LOQ) studies to establish the new reportable range. Reference ranges updated based on literature (Henry's Clinical Diagnostics and Management by Laboratory Methods, 21st ed).

Technological Characteristics

Multilayered analytical element on polyester support. Colorimetric rate sensing principle. Uses VITROS DT60/DT60II Chemistry Systems. Calibration traceable to GC/IDMS and NIST SRM 914. Software-resident rate math model used for calculation.

Indications for Use

Indicated for the quantitative determination of creatinine in urine.

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 urCR assay (K934071)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k071215

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.) k934071, KODAK EKTACHEM DT slides (urCR) and KODAK EKTACHEM DT Calibrator kit
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. 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 DT calibrator kit.
B. A change in the reference range for urCR assay (urine creatinine) based on literature reference. The new reference ranges are: male: 1000-2000 mg/day, female: 800-1800 mg/day.
*Reference: McPherson R. Pincus M (eds.). Henry's Clinical Diagnostics and Management by Laboratory Methods. 21st edition, Philadelphia: Saunders Elsevier.
C. A change in the reportable range for urCR assay (urine creatinine) based on the linearity studies, LOD and LOQ studies. The new reportable range is 1.0-339.2 mg/dL.

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