DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE

K062316 · Dade Behring, Inc. · JIF · Sep 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062316
• Device Name: DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Indications for Use

The AMON method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista™ System.

Device Story

The Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge is a prepackaged in-vitro diagnostic test for use on the Dimension Vista™ Integrated system. The device processes human plasma samples to measure ammonia levels. It utilizes the same enzymatic reagents as the predicate Dimension® system cartridges but is housed in a modified 12-well flexible plastic cartridge designed for the Vista™ platform. The system is a fully automated, microprocessor-controlled clinical chemistry analyzer. The device performs a bichromatic rate measurement at 340 and 383 nm. Results are provided to healthcare providers to assist in the diagnosis and management of liver disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to demonstrate predetermined acceptance criteria met.

Technological Characteristics

Reagent-based diagnostic system; modification involves application of reagents to new system platform. Fundamental scientific technology unchanged.

Indications for Use

Indicated for the quantitative measurement of ammonia in human plasma. Used in the diagnosis and treatment of severe liver disorders, including cirrhosis, hepatitis, and Reye's syndrome.

Regulatory Classification

Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K062316

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.
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 application of the reagents to a new system

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