DIMENSION VISTA FLEX REAGENT CARTRIDGES

K061655 · Dade Behring, Inc. · LDP · Jul 10, 2006 · Clinical Toxicology

Device Facts

• Record ID: K061655
• Device Name: DIMENSION VISTA FLEX REAGENT CARTRIDGES
• Applicant: Dade Behring, Inc.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The Dimension Vista Flex Reagent Cartridges are intended for use on the Dimension Vista Integrated System.

Device Story

Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test kits for use on the Dimension Vista™ Integrated System; a floor-model, fully automated, microprocessor-controlled instrument. Cartridges contain reagents for various clinical chemistry and therapeutic drug monitoring assays. The system processes human serum, plasma, urine, or CSF samples. The device automates sample handling and reagent delivery to perform quantitative measurements. Healthcare providers use the resulting analyte concentrations to diagnose conditions like overdose, lipid disorders, or organ dysfunction and to monitor therapeutic drug levels. The system is intended for clinical laboratory use.

Clinical Evidence

Bench testing only. Design control activities and risk analysis performed to validate packaging modifications; results met predetermined acceptance criteria.

Technological Characteristics

Reagent cartridges for in vitro diagnostic use; packaging modification; fundamental scientific technology identical to predicate; system-specific form factor for Dimension Vista Integrated System.

Indications for Use

Indicated for use on the Dimension Vista Integrated System for in vitro diagnostic testing. Patient population and disease state are defined by the specific assays contained within the reagent cartridges.

Regulatory Classification

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Predicate Devices

• Dimension® ACTM Flex® reagent cartridge (K963244)
• Dimension® AMY Flex® reagent cartridge (K942640)
• Dimension® CK Flex® reagent cartridge (K941584)
• Dimension® CHOL Flex® reagent cartridge (K861700)
• Dimension® GGT Flex® reagent cartridge (K861700)
• Dimension® GLUC Flex® reagent cartridge (K031135)
• Dimension® AHDL Flex® reagent cartridge (K053157)
• Dimension® ALDL Flex® reagent cartridge (K020724)
• Dimension® LIDO Flex® reagent cartridge (K033809)
• Dimension® MG Flex® reagent cartridge (K861700)
• Dimension® PCHE Flex® reagent cartridge (K950180)
• Dimension® PHOS Flex® reagent cartridge (K861700)
• Dimension® PROC Flex® reagent cartridge (K032573)
• Dimension® SAL Flex® reagent cartridge (K904301)
• Dimension® T4 Flex® reagent cartridge (K862359)
• Dimension® TOBRA Flex® reagent cartridge (K962818)
• Dimension® TGL Flex® reagent cartridge (K010871)
• Dimension® URCA Flex® reagent cartridge (K862359)
• Dimension® VALP Flex® reagent cartridge (K982880)
• Dimension® VANC Flex® reagent cartridge (K963267)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k061655

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the DIMENSION VISTA FLEX REAGENT CARTRIDGES:

1. The name and 510(k) number of DADE BEHRING, INC.'s previously cleared device, Dimension Vista Integrated System, cleared under k051087. (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.
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 packaging modification of DADE BEHRING, INC.'s Dimension Flex reagents for use on the Dimension Vista Integrated System.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
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.