DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

K083465 · Siemens Healthcare Diagnostics · CGS · Feb 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083465
• Device Name: DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CGS · Clinical Chemistry
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

Reagent cartridges for Dimension Vista clinical chemistry system; perform in vitro quantitative measurement of CK and CK-MB activity in human serum/plasma. CKI method: coupled enzyme reaction; CK catalyzes transphosphorylation of creatine phosphate to ADP, producing ATP; hexokinase uses ATP to phosphorylate glucose; G-6-PDH oxidizes resulting glucose-6-phosphate with simultaneous reduction of NADP to NADPH. MBI method: antibody inhibits CK-M subunit; CK-B activity measured via similar coupled enzyme reaction. Rate of NADPH formation measured bichromatically at 340 and 540 nm; proportional to CK/CK-B activity. Used in clinical laboratory settings by trained personnel. Output provides quantitative enzyme activity levels to clinicians for diagnosis and management of myocardial infarction and muscular dystrophies.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to reagent volume and instrument platform did not impact device performance.

Technological Characteristics

Reagent test cartridge; modified for Dimension Vista instrument platform. Fundamental scientific technology identical to predicate. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of creatine kinase (CK) and creatine kinase MB (CK-MB) isoenzyme activity in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, including progressive Duchenne-type muscular dystrophy.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Dimension® (CKI) Flex® Reagent Cartridge (DF38) (K081731)
• Dimension® (MBI) Flex® Reagent Cartridge (DF32) (K081731)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k083465

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.) k081731
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.

In comparison to the parent predicate device, the new device is used on a different instrument, as a result, the volume of the identical reagents used have been changed.

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

The differences are, instrument has been changed from Dimension to Dimension Vista®, new test utilizes less reagent volume, and the number of tests per test cartridge increased.

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 included:

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.