DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

K061793 · Dade Behring, Inc. · JIY · Aug 7, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061793
• Device Name: DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIY · Clinical Chemistry
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Indications for Use

The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism. The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.

Device Story

Dimension Vista IRON Flex reagent cartridge and Iron Calibrator are in vitro diagnostic components for the Dimension Vista system. The assay uses a bichromatic endpoint technique (600 and 700 nm) to measure iron concentration. Process: acidic release of iron from transferrin; reduction of Fe+++ to Fe++ by ascorbic acid; formation of a blue complex with Ferene chromophore. Absorbance is directly proportional to transferrin-bound iron. Used in clinical laboratories by trained personnel. Output provides quantitative iron levels to clinicians for diagnosing and monitoring iron deficiency anemia and metabolic disorders. Calibrator is an aqueous solution of iron wire in HCl used to calibrate the assay.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance after modification to VISTA Analyzer platform.

Technological Characteristics

Reagent cartridge: 8-well plastic cartridge containing Ferene, thiourea, and ascorbic acid. Measurement: bichromatic endpoint (600/700 nm). Calibrator: aqueous solution of iron wire in HCl. Standardization: NIST SRM 937. System: Dimension Vista automated analyzer.

Indications for Use

Indicated for quantitative measurement of iron in human serum and plasma to aid in diagnosis and treatment of iron deficiency anemia and iron metabolism disorders. Calibrator indicated for use with the Dimension Vista system iron assay.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Predicate Devices

• k060264

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 k061793

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.) k060264
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 adapting the reagents for use on the VISTA Analyzer.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Differences are the analyzer and the number of calibration points (2 calibration points on the new device; 3 on the predicate device)

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.