DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

K081643 · Siemens Healthcare Diagnostics · MMI · Jul 3, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081643
• Device Name: DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
• Applicant: Siemens Healthcare Diagnostics
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jul 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The CTNI Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL TM integrated chemistry system with LOCI® module.

Device Story

Dimension® TNI Flex® reagent cartridge is an in vitro diagnostic immunoassay for cardiac troponin I (cTnI) measurement on the Dimension® EXL™ system. Uses LOCI® (Luminescent Oxygen Channeling Immunoassay) technology; sandwich chemiluminescent immunoassay. Input: human serum or plasma sample. Process: sample incubated with biotinylated anti-cTnI monoclonal antibody and Chemibeads (coated with second anti-cTnI antibody, containing chemiluminescent dye); Sensibeads (coated with streptavidin, containing photosensitizer dye) added to form bead-pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads; diffuses to Chemibeads to trigger chemiluminescence. Output: signal measured at 612 nm, proportional to cTnI concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in AMI diagnosis and patient risk stratification. CTNI Sample Diluent provided for manual dilution of samples with elevated cTnI levels.

Clinical Evidence

Bench testing only. Precision and method comparison studies performed against automated laboratory analyzer to validate performance characteristics of the reconfigured 8-well reagent cartridge.

Technological Characteristics

In vitro diagnostic reagent cartridge; 8-well configuration; immunoassay-based quantification; designed for use on Dimension EXL with LM system; design controls per 21 CFR 820.30.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the quantitative determination of Cardiac Troponin I (cTnI) in human serum and plasma on the Dimension Vista system.

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 Vista® CTNI Flex® reagent cartridge (K063756)
• Dimension Vista® CTNI Sample Diluent (K053577)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k081643

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.) Dimension Vista CTNI Flex reagent cartridge, k063756

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 re-configure the reagent cartridge from a 12 wells cartridge to an 8 wells cartridge to be used on the Dimension EXL with LM system.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance characteristics. Studies include precision and method comparison with an automated laboratory analyzer.

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

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.