GENTIAN CYSTATIN C IMMUNOASSAY

K081875 · Gentian AS · NDY · Aug 20, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081875
• Device Name: GENTIAN CYSTATIN C IMMUNOASSAY
• Applicant: Gentian AS
• Product Code: NDY · Clinical Chemistry
• Decision Date: Aug 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

The Gentian Cystatin C Immunoassay is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum and plasma. The measurement of cystatin C is used as an aid in the diagnosis and monitoring of impaired renal function.

Device Story

In vitro diagnostic immunoassay; measures cystatin C in human serum/plasma; aids diagnosis/monitoring of impaired renal function. Modification involves application of existing Gentian Cystatin C Immunoassay to Beckman Coulter Synchron LX20 and UniCel DxC automated analyzers. Device operates via automated laboratory analyzer; provides quantitative results to clinicians. Used in clinical laboratory settings by trained laboratory personnel. Output assists healthcare providers in assessing renal status; supports clinical decision-making regarding kidney function management.

Clinical Evidence

Bench testing only. Performance verification included precision studies and method comparison studies conducted on automated laboratory analyzers (Beckman Coulter Synchron LX20 and UniCel DxC) to demonstrate equivalence to the predicate device.

Technological Characteristics

PETIA assay using activated polystyrene microspheres coated with avian anti-human cystatin C antibodies. Measures light absorbance on automated clinical chemistry analyzers. Measuring range 0.4-8.0 mg/L. Reagent stability 24 months at 2-8°C. Sample matrix: serum, EDTA plasma, LiHeparin plasma.

Indications for Use

Indicated for the quantitative determination of cystatin C in human serum and plasma to aid in the diagnosis and treatment of renal diseases.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Gentian Cystatin c Immunoassay (k071388)

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: k081875

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.) Gentian Cystatin c Immunoassay, k071388

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: Applying Gentian Cystatin c immunoassay on the Beckman Coulter Sychron LX20 and UniCel DxC analyzers.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance characteristics. Studies include precision and method comparison with an automated laboratory analyzer.

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.