DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE

K061020 · Dade Behring, Inc. · CKA · May 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061020
• Device Name: DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
• Applicant: Dade Behring, Inc.
• Product Code: CKA · Clinical Chemistry
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Indications for Use

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System.

Device Story

Prepackaged in-vitro diagnostic Flex® reagent cartridges for use on the automated, microprocessor-controlled Dimension Vista™ Integrated system. Cartridges contain reagents for quantitative measurement of ALB, AST, CRBM, ALT, and TIBC in human serum and plasma. System automates sample processing and analysis; results provided to clinicians for diagnosis and therapeutic monitoring of liver, kidney, heart, and hematological conditions. Packaging modification allows use of previously cleared reagents on the Vista™ platform; fundamental scientific technology remains unchanged from predicate Dimension® systems.

Clinical Evidence

Bench testing only. Submitter provided design control documentation, risk analysis, and verification/validation results confirming that repackaging did not impact reagent performance or safety compared to the predicate devices.

Technological Characteristics

Prepackaged 12-well flexible plastic reagent cartridges. Automated, microprocessor-controlled integrated instrument system. Reagents identical to those used in Dimension® clinical chemistry systems. Calibration interval 30-90 days.

Indications for Use

Indicated for use as in vitro diagnostic reagents for the quantitative determination of specific analytes (AST, ALB, ALT, CRBM, TIBC) in human serum or plasma samples on the Dimension Vista system.

Regulatory Classification

Identification

An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Predicate Devices

• Dimension® ALB Flex® reagent cartridge (K861700)
• Dimension® AST Flex® reagent cartridge (K860021)
• Dimension® CRBM Flex® reagent cartridge (K962820)
• Dimension® ALT Flex® reagent cartridge (K862359)
• Dimension® IBCT Flex® reagent cartridge (K994115)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K061020

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.)
k860021 – Dimension Vista AST Flex reagent cartridge
k861700 – Dimension Vista ALB Flex reagent cartridge
k862359 – Dimension Vista ALT Flex reagent cartridge
k962820 – Dimension Vista CRBM Flex reagent cartridge
k994115– Dimension Vista TIBC Flex reagent cartridge

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 repackaging existing reagents.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, sample type, analytes, and detection methods.

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.