DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

K081992 · Siemens Healthcare Diagnostics, Inc. · MKW · Aug 5, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081992
• Device Name: DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: MKW · Clinical Chemistry
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1235
• Device Class: Class 2

Indications for Use

The Dimension FLEX Cyclosporine Assay is an in vitro diagnostic test for the quantitative determination of cyclosporine in human whole blood on the Dimension clinical chemistry system. The measurements are used as an aid in the management of cyclosporine therapy in renal, liver, and heart transplant patients.

Device Story

The Dimension Vista® CSAE Flex® reagent cartridge is an in-vitro diagnostic assay for measuring cyclosporine A (CSA) in whole blood. Used on the automated Dimension Vista® system, the device processes whole blood samples via an immunoassay technique. The system lyses the sample, mixes it with a B-galactosidase-CSA antibody conjugate, and adds magnetic particles coated with CSA to bind unbound antibody-enzyme conjugate. Following magnetic separation, the supernatant is mixed with a CPRG substrate. B-galactosidase hydrolyzes CPRG to produce chlorophenol red (CPR), which is measured via bichromatic (577nm, 700nm) rate photometry. The change in absorbance is directly proportional to the CSA concentration in the sample. The device is intended for clinical laboratory use to assist healthcare providers in managing transplant patients. The system provides quantitative results that inform therapeutic drug monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis (FMEA), and verification/validation testing demonstrating that modifications to packaging and volume do not affect performance.

Technological Characteristics

In-vitro diagnostic immunoassay using magnetic particle separation. Reagents include pretreatment reagent, B-galactosidase-CSA antibody conjugate, CSA-coated chromium dioxide particles, and CPRG substrate. Bichromatic rate measurement at 577nm and 700nm. Analytical measurement range: 350–2000 ng/mL. Sample size: 1.12 µL. Form factor: 12-well prepackaged plastic reagent cartridge. System: Fully automated, microprocessor-controlled floor model analyzer.

Indications for Use

Indicated for the quantitative measurement of cyclosporine A (CSA) in human whole blood to aid in the management of heart, liver, and kidney transplant patients.

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® CSAE Flex® reagent cartridge (K052017)

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 K081992

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.)
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 of the Dimension FLEX Cyclosporine Assay to allow application on the Dimension Vista FLEX System.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and The differences are changes in total volume and in packaging. The ratios of all components remain the same. Performance is not changed in any way that is likely to affect clinical use. This change is documented in the labeling.

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. FMEA risk 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.