DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc. · KHS · May 25, 2006 · Clinical Chemistry
Device Facts
Record ID
K061238
Device Name
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
Product Code
KHS · Clinical Chemistry
Decision Date
May 25, 2006
Decision
SESE
Submission Type
Special
Regulation
21 CFR 862.1160
Device Class
Class 2
Indications for Use
Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System. Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System. Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 System.
Device Story
Modification of existing clinical chemistry analyzer platform (Vista) to support carbon dioxide, creatinine, and lactate dehydrogenase assays; previously cleared on Dimension platform. Modification involves optimization of reagent and sample volumes to increase test capacity per reagent pack. Device operates in clinical laboratory settings; used by laboratory technicians. Output consists of quantitative analyte concentrations; assists clinicians in diagnostic assessment of metabolic and organ function. Fundamental scientific technology remains unchanged from predicate.
Clinical Evidence
Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to reagent and sample volumes for carbon dioxide, creatinine, and lactate dehydrogenase assays met predetermined acceptance criteria.
Technological Characteristics
Prepackaged 12-well plastic reagent cartridges. Automated, microprocessor-controlled integrated instrument system. Reagents are identical to those in predicate Dimension® systems. Calibration intervals range from 30 to 90 days depending on the method.
Indications for Use
Indicated for quantitative measurement of CO2 in human serum/plasma for diagnosis/treatment of acid-base balance disorders; creatinine in human serum, plasma, and urine for diagnosis/treatment of renal disease and monitoring dialysis; and LDH in human serum/plasma for diagnosis/treatment of liver diseases (e.g., hepatitis, cirrhosis, carcinoma), cardiac diseases (e.g., myocardial infarction), and lung/kidney tumors. Prescription use only.
Regulatory Classification
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)
To: THE FILE
RE: DOCUMENT NUMBER K061238
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:
introduction of previously cleared assays for carbon dioxide, creatinine, and lactate dehydrogenase on a cleared family member.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and: number of tests per reagent pack. The new Vista platform supports more tests per pack than the Dimension platform. This was accomplished by decreasing both the reagent and sample volumes.
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.
