LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

K031575 · Cliniqa Corporation · JJY · Jul 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031575
• Device Name: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Olympus ®AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive protein, Compliment C3, Compliment C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of reportable range.

Device Story

LiniCAL™ Protein 2 Calibration Verifiers consist of five assayed levels of specific human-derived proteins; used in clinical laboratories to verify calibration and assess linearity of Olympus® AU Analyzers. Device provides a reference material to monitor the reportable range of clinical chemistry assays. Laboratory technicians use the verifiers to ensure instrument accuracy; results allow clinicians to validate patient test values within the analytical measurement range. Benefits include improved confidence in diagnostic accuracy for protein-based assays.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human serum-based liquid material; contains sodium azide preservative. Five-level concentration matrix. Optimized for Olympus AU Analyzers. Traceable to IFCC CRM 470 and WHO standards. Evaluated per NCCLS EP6 linearity standards.

Indications for Use

Indicated for use in clinical laboratories to verify calibration and assess linearity of Olympus® AU Analyzers for specific protein analytes (ASO, CRP, C3, C4, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin). No specific patient population or contraindications stated.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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I. 510(k) Number: K031575

II. Analyte: LiniCAL™ Protein 2 Calibration
verifiers
Level S A-E for Olympus ®AU
Analyzers

III. Type of test: Calibration Verification Material

IV. Applicant Information:

A. Name of Applicant: CLINIQA Corporation
B. Mailing Address: 1432 South Mission Road
Fairbrook, CA 92028
C. Phone #: [phone]
D. Fax #: [phone]
E. E-mail address (optional):
F. Contact: Ms. Carol Ruggiero
Director, Regulatory Affairs

V. Establishment Registration: 2085064

VI. Regulatory Information:

A. Regulation section: Class 1
B. Classification: 862.1660
C. Product Code: JJY – Multi-analyte Quality Control
Material
(assayed and un assayed)
D. Panel:

VII. Intended Use (per labeling):

CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Olympus ®AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive protein, Compliment C3, Compliment C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of reportable range.

A. Special Instrument Requirements: OLYMPUS ® AU Analyzers

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B. Special condition for use statement(s): None
C. Indication for use: Allow monitoring of reportable range.

Device description: CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are human serum based material with preservatives and stabilizers (sodium azide). The product is sold in liquid form (ready to use). Level A is to assess the lower limit of the reportable range. Level E is for assessing upper limit of reportable range. Levels BCD are intermediate concentrations.

VI. Substantial Equivalence Information:

A. Predicate Device(s): CLINIQA Corporation’s LiniCAL™ Protein 1 Calibration Verifiers Levels A-E for Beckman Coulter Image™
B. Predicate K number(s): K013332
C. Comparison with predicate: Predicate is for calibration of Beckman Coulter Immage® while the current calibration verifier is for Olympus AU Analyzers. Both devices are serum based products manufactured using the same process. The devices are different in constituents and target concentrations. The current one is optimized for the Olympus AU Analyzers.
D. Standard/Guidance document referenced (if applicable): NCCLS EP6 – for evaluation of linearity

VII. Test Principle: Not applicable

VIII. Performance and Stability Studies:

Five levels of LiniCAL protein 2 Calibration Verifiers for Olympus AU Analyzers (5 lots) were prepared by mixing human serum based sub fractions containing Anti-Streptolysin O, C-Reactive protein, Compliment 3, Compliment 4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Pre-albumin, and Transferrin.

The manufacturing target concentrations are based on the performance of the Olympus AU Analyzer. The concentrations have been tested for all 5 levels. The base line recovery data for all 5 levels of calibrators indicated that the concentrations were within pre-specified limits (approximately 10-20% of target concentrations).

Stability was determined using accelerated temperatures estimated from different temperature settings (e.g. 2-8, 25, 37, and 45 degree centigrade) using Arrhenius plot/model.

For open vial stability the vials were kept at 2-8 degree centigrade and brought to room temperature and tested using Olympus AU 400 Analyzers and appropriate assay reagents.

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The stability for unopened vial at 2-8 degree centigrade is projected as 3.0 years based on the accelerated study data. Open vial stability at 2-8 degree centigrade is projected as 30 days.

A. Analytical Performance:

1. Precision (intra-assay)/Reproducibility: Not applicable
2. Linearity/assay reportable range: Not applicable
3. Traceability/controls:

IFCC reference preparation for plasma proteins CRM 470 WHO standard for ASO

4. Detection limit (functional sensitivity): Not applicable
5. Analytical Specificity: Not applicable

B. Comparison studies: Not applicable

1. Matrix comparison:
2. Method comparison:
3. Clinical sensitivity:
4. Clinical specificity:

C. Cut-off: Not applicable
D. Expected values/Reference range:

ASO IU/dL - 120 for level A and level E
CRP mg/dL - 0.870 for level A for level E
C3 mg/dL - 39.0 for level A and 485 for level E
C4 mg/dL - level A 13.0 and 119 for level E
FER mg/dL - level A14.9 and 344 for level E
IgA mg/dL - level A 59.3 and for level E 676
IgG mg/dL - level A 339 and for level E 2629
IgM mg/dL - level A 42.6 and for level E 432
PAB mg/dL - level A 7.40 and level E 65.0
TRF mg/dL - level A 102 and level E 627

X. Conclusion: CLINQA Corporation's (previously known as International Enzymes) LiniCAL™ Protein 2 Calibration Verifiers Levels A-E for Olympus AU Analyzers is substantially equivalent to CLINIQA Corporations LiniCAL Protein 1 calibration verifiers used for Beckman Coulter Immage™.