DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

K062236 · Dade Behring, Inc. · MKW · Aug 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062236
• Device Name: DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: MKW · Clinical Chemistry
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1235
• Device Class: Class 2

Indications for Use

The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.

Device Story

The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in-vitro diagnostic test for use on the fully automated, microprocessor-controlled Dimension Vista™ Integrated system. It utilizes prepackaged 12-well flexible plastic reagent cartridges containing the same reagents as the predicate Dimension® system. The device processes human whole blood samples to measure cyclosporine A concentrations via a bichromatic rate measurement at 577 and 700 nm. Operated by laboratory personnel in a clinical setting, the system provides quantitative results to assist clinicians in managing transplant patients on cyclosporine therapy. This submission represents a packaging modification to enable use on the Vista platform; the fundamental scientific technology and intended use remain unchanged from the predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of analytical performance characteristics between the subject and predicate devices.

Technological Characteristics

Reagent cartridge for clinical chemistry analysis. Fundamental scientific technology unchanged from predicate. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of cyclosporine A in human whole blood to aid management of heart, liver, and kidney transplant patients receiving cyclosporine therapy.

Regulatory Classification

Identification

A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.

Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

Predicate Devices

• Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065)

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 k062236

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. (k023065, Dimension Cyclosporine (CSA) Flex reagent cartridge
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 repackaging existing reagents.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, sample type and size, physical characteristics and detection methods. Studies performed include method comparison, precision, sensitivity, specificity, reportable range and reference range.

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.