THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

K062128 · Dade Behring, Inc. · JHS · Aug 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062128
• Device Name: THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
• Applicant: Dade Behring, Inc.
• Product Code: JHS · Clinical Chemistry
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The CKMB method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB Isoenzyme in human serum and plasma on the Dimension Vista™ System. The HA1C assay used on the Dimension Vista™ System is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c (HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus. The AMPH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300. 500. or 1000 ne/mL on the Dimension Vista™ System. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The BARB method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of barbiturates in human urine on the Dimension Vista™ System. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BENZ method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzodiazepines in human urine on the Dimension Vista™ System. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The Cocaine method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzoylecgonine in human urine on the Dimension Vista™ System. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The EXTC method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of methylenedioxymethamine (MDMA) and closely related drugs in human urine using a cutoff of 300 or 500 ng/mL on the Dimension Vista™ System. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The METH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of methadone in human urine on the Dimension Vista™ System. Measurements obtained with the METH method are used to detect methadone use or overdose, and to determine compliance with methadone maintenance treatment. The OPI method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of opiates in human urine on the Dimension Vista™ System. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The PCP method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of phencyclidine in human urine on the Dimension Vista™ System. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The THC method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of cannabinoids in human urine on the Dimension Vista™ System. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose.

Device Story

Dimension Vista™ Flex® reagent cartridges and HA1C kit are prepackaged reagents for use on the Dimension Vista™ integrated system; a fully automated, microprocessor-controlled, floor-model clinical chemistry analyzer. System processes human serum, plasma, or urine samples to measure specific analytes. Reagents are identical to those used in previously cleared Dimension® clinical chemistry systems; packaging modified for Vista™ compatibility. Healthcare providers use quantitative or qualitative/semi-quantitative outputs to assist in diagnosing myocardial infarction, monitoring diabetes, or screening for drug use/overdose. Preliminary drug screen results require confirmatory testing. System automates sample handling, reagent delivery, and analysis, providing results to clinicians for diagnostic and treatment decision-making.

Clinical Evidence

Bench testing only; precision and method comparison studies conducted to validate performance of reagent packs on the new analyzer platform.

Technological Characteristics

Reagent packs for use with clinical chemistry analyzer. Modification involves platform compatibility. No changes to fundamental scientific technology.

Indications for Use

Indicated for quantitative measurement of CKMB in serum/plasma for diagnosis/treatment of myocardial infarction and muscle diseases; quantitative determination of HbA1c in anticoagulated whole blood for monitoring long-term glucose control in diabetics; qualitative/semi-quantitative screening of urine for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, ecstasy (MDMA), methadone, opiates, phencyclidine, and cannabinoids for diagnosis/treatment of drug use or overdose. Preliminary results require confirmation via alternate chemical methods (e.g., GC/MS).

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.

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 K062128

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:

movement of previously cleared reagent packs to a related, previously cleared analyzer.

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

precision and method comparison studies.

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:

The company used a FMEA (bottom up) analysis. From their risk analysis, the company did not identify any issues that merited further investigation or control.

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

The company did not identify issues in their risk analysis that required further analysis in their verification and/or validation activities. The company did conduct precision and method comparison studies independent of their risk analysis.

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

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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.