DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE

K081300 · Siemens Healthcare Diagnostics · JHM · Jul 2, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081300
• Device Name: DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JHM · Clinical Chemistry
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Device Story

Dimension Vista® HDLC Flex® reagent cartridge is a pre-packaged in-vitro diagnostic assay for use on the Dimension Vista® integrated, automated clinical chemistry system. The device measures serum HDL cholesterol directly without sample pretreatment. Principle: two-reagent format; first reaction uses dextran sulfate and magnesium sulfate to form complexes resistant to PEG-modified cholesterol esterase and oxidase; second reaction oxidizes HDL cholesterol to A-4-cholestenone, generating hydrogen peroxide; peroxide reacts with 4-aminoantipyrine and HSDA to form a dye. Output: color intensity measured via bichromatic (600/700 nm) technique, proportional to HDL-C concentration. Used in clinical laboratories by trained personnel. Results assist healthcare providers in diagnosing lipid disorders and assessing cardiovascular risk.

Clinical Evidence

No clinical data provided; substantial equivalence established via comparative bench testing and performance evaluation against the predicate device, including reportable range, sample type, and CRMLN certification.

Technological Characteristics

In-vitro diagnostic assay; liquid reagent format; pre-packaged in 12-well flexible plastic cartridges. Measurement principle: bichromatic endpoint spectrophotometry at 600/700 nm. System: fully automated, microprocessor-controlled integrated instrument. Sample types: serum, lithium heparin plasma, sodium heparin plasma. Reportable range: 3-150 mg/dL. Calibration interval: 90 days.

Indications for Use

Indicated for quantitative measurement of HDL-C in human serum and plasma to aid in diagnosis of lipid disorders (e.g., diabetes mellitus), liver/renal diseases, and assessment of atherosclerosis/cardiovascular disease risk.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• Dimension® AHDL Flex® reagent cartridge (K073072)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k081300

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 HDLC Flex Reagent:

1. The name and 510(k) number of Siemens Healthcare Diagnostics' previously cleared device, Dimension AHDL reagent, cleared under k073072. (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 only for packaging and parameter modifications to allow use on the Dimension Vista 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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised: 8/1/03