VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

K072443 · Ortho-Clinical Diagnostics, Inc. · CJY · Sep 24, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072443
• Device Name: VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Sep 24, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Device Story

VITROS Chemistry Products Ca DT slide; in vitro diagnostic device for calcium measurement. Modification involves change in manufacturing process and formulation of spreading layer component. Device operates via chemical reaction on slide; used in clinical laboratory settings by trained personnel. Output provides quantitative calcium concentration to assist clinicians in diagnosis and monitoring of calcium metabolism disorders. Modification verified via FMECA risk analysis and design control activities to ensure performance equivalence to previously cleared version.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to confirm modification impact.

Technological Characteristics

In vitro diagnostic slide for calcium measurement. Modification to spreading layer formulation. Fundamental scientific technology unchanged from predicate. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for in vitro diagnostic measurement of calcium in serum and plasma to aid in diagnosis and treatment of parathyroid disease, bone disorders, chronic renal disease, and tetany.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• VITROS Chemistry Products Ca DT slide (k870035)

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 k072443

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.) k870035
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 modification in the manufacturing process. The VITROS Chemistry Products Ca DT slide is being modified due to a change in the formulation of a component of the slide, the spreading layer.

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