DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

K131556 · Diazyme Laboratories · JIT · Jun 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131556
• Device Name: DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
• Applicant: Diazyme Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 26, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only. The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.

Device Story

The Diazyme Lp(a) Calibrator and Control Sets are liquid-stable, human serum-based reagents used to calibrate and monitor the quality of the Diazyme Lipoprotein (a) Assay. The assay utilizes latex-enhanced immunoturbidimetry; Lp(a) in patient samples binds to anti-Lp(a) antibodies coated on latex particles, causing agglutination. The resulting turbidity is measured optically on clinical chemistry analyzers (e.g., Olympus AU400). The degree of turbidity is proportional to the Lp(a) concentration. These products are used by laboratory technicians in clinical settings to ensure accurate quantification of Lp(a). The output provides clinicians with quantitative Lp(a) levels, which are used in conjunction with clinical evaluation to assess lipid metabolism and atherosclerotic cardiovascular disease risk.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was demonstrated through bench testing, including 20-day precision, linearity, LOB/LOD/LOQ verification, interference studies, and stability testing (accelerated and real-time). Accuracy was established via method comparison between the modified device and the predicate (K082488) using patient serum samples, demonstrating excellent correlation.

Technological Characteristics

Liquid-stable human serum-based calibrators and controls containing Lp(a) and preservatives. Principle: Latex-enhanced immunoturbidimetry. Dynamic range: 0-100 mg/dL. Designed for use on automated clinical chemistry analyzers (e.g., Olympus AU400).

Indications for Use

Indicated for use as a calibrator and quality control set for the Diazyme Lipoprotein (a) Assay in clinical laboratories to assist in the evaluation of lipid metabolism disorders and assessment of atherosclerotic cardiovascular disease risk in patients.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Diazyme Lp(a) calibrators and controls (K082488)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K 131556

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.) Diazyme Lp(a) calibrators and controls (K082488)

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: Modification to the supplied forms of calibrators and controls from lyophilized powder to liquid form.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytical studies performed include method comparison, precision, limits of Detection/Quantitation, linearity, open/closed vial stability and interference.

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.