VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927

K071216 · Ortho-Clinical Diagnostics, Inc. · JFY · May 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071216
• Device Name: VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 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 CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma 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 chemistry products DT calibrator kit used for serum creatinine (CRSC) assay calibration. Modification involves updating traceability method to GC-IDMS reference method; updating reference ranges based on study of 113 males and 195 females (male: 0.7-1.3 mg/dL; female: 0.6-1.0 mg/dL); and updating reportable range to 0.2-11.2 mg/dL based on linearity, LOD, and LOQ studies. Device used in clinical laboratory settings to support diagnostic testing. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Internal study of 113 males and 195 females used to establish new reference ranges. Linearity, LOD, and LOQ studies performed to establish new reportable range of 0.2-11.2 mg/dL.

Technological Characteristics

Multilayered analytical element on polyester support. Colorimetric rate sensing principle. Lyophilized bovine serum-based calibrators. System uses software-resident rate math model for calculation. Connectivity via VITROS DT60/DT60II Chemistry Systems.

Indications for Use

Indicated for the quantitative measurement of creatinine in serum using the VITROS chemistry products DT calibrator kit.

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 CRSC assay (K875191)
• VITROS Chemistry Products DT Calibrator Kit (K934071)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k071216

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.) k875191, KODAK EKTACHEM DT slides (CRSC)

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 the CRSC assay (serum creatinine) based on the central 95% of results from an internal study of 113 males and 195 females. The new reference ranges are: male: 0.7-1.3 mg/dL, female: 0.6-1.0 mg/dL.

C. A change in the reportable range for the CRSC assay (serum creatinine) based on the linearity studies, LOD and LOQ studies. The new reportable range is 0.2-11.2 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.