LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

K033162 · Cliniqa Corporation · JJY · Oct 10, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033162
• Device Name: LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The CLINIQA Chemistry Calibration Verifiers Levels A – E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium use as an assayed quality control material for analysis.

Device Story

LiniCAL™ Chemistry Calibration Verifiers are liquid, assayed quality control products designed for use with Olympus AU Systems. The device provides five distinct concentration levels for a panel of chemistry analytes, including Albumin, BUN, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium. Used in clinical laboratory settings by laboratory professionals to verify the calibration and performance of the Olympus AU chemistry analyzers. The product serves as a reference material to ensure the accuracy and precision of patient sample testing. By comparing analyzer results against the known values of the verifiers, clinicians can assess system linearity and performance, ensuring reliable diagnostic data for patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Serum-based liquid quality control material; five-level concentration format; designed for use with Olympus AU Systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an assayed, liquid quality control product to evaluate the performance of Olympus AU Systems for specific chemistry analytes (Albumin, BUN, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, Potassium) at five concentrations. No specific patient population or contraindications provided.

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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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: K033162

B. Analyte: LiniCAL Chemistry Calibration verifiers A – E for Olympus AU Systems containing the following analytes; Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations.

C. Type of Test: n/a

D. Applicant: CLINIQA

E. Proprietary and Established Names: Quality Control Material

F. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class 1
3. Product Code: JJY
4. Panel: 75

G. Intended Use:
1. Indication(s) for use: The CLINIQA Chemistry Calibration Verifiers Levels A – E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium use as an assayed quality control material for analysis.
2. Special condition for use statement(s): none
3. Special instrument Requirements: none

H. Device Description: The CLINIQA Chemistry Calibration Verifiers Levels A – E are used in the clinical laboratory to verify calibration and/or assess linearity of the Olympus AU Systems. Five assayed levels Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium are provided to allow monitoring of the reportable range.

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# I. Substantial Equivalence Information:

1. Predicate device name(s): CLINIQA LiniCAL Chemistry Calibration Verifiers Levels A – E for Beckman Coulter Synchron Systems
2. Predicate K number(s): K031921
3. Comparison with predicate: Both devices are serum based products containing Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium at five useful concentrations and are manufactured using the same processes. The differences between the two products are the constituents and their target concentrations which have been optimized for each test system.

# J. Standard/Guidance Document Referenced (if applicable): N/A

# K. Test Principle: N/A

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/a
c. Traceability (controls, calibrators, or method): None provided
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: See the package insert for specific calibrator concentrations.

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M. Conclusion: Based upon the information provided, I recommend that the LiniCAL Chemistry Calibration verifiers A – E for Olympus AU Systems containing the following analytes; Albumin, Blood Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus, Total Protein, Triglycerides, Glucose, Iron, Sodium, Chloride, and Potassium levels A – E, be found substantially equivalent with predicate devices according to 21 CFR 862.1660.