LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS

K040455 · Cliniqa Corporation · JJX · Mar 5, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040455
• Device Name: LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Cliniqa LiniCAL™ 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 Uric Acid at five useful concentrations. For professional prescription use only

Device Story

LiniCAL Uric Acid Calibration Verifiers are liquid, assayed quality control materials used to verify the performance and calibration of clinical chemistry analyzers, specifically Olympus AU Systems. The device consists of five levels (A-E) of control material containing known concentrations of uric acid. Laboratory personnel use these verifiers to assess the accuracy and precision of the analyzer's measurement process. By comparing the analyzer's measured values against the assigned values of the verifiers, clinicians can ensure the system is operating within established performance specifications, thereby supporting reliable diagnostic testing for patients.

Clinical Evidence

No clinical data. Bench testing only; stability studies performed for real-time, open vial, and accelerated conditions with acceptance criteria of +/- 10% of reference value. Values assigned gravimetrically using commercially available assays.

Technological Characteristics

Liquid, assayed quality control material. Five levels (A-E) with specific uric acid concentrations. Designed for use with Olympus AU clinical chemistry systems. No energy source or software components.

Indications for Use

Indicated for use as an assayed, liquid quality control product to evaluate the performance of clinical chemistry systems within useful concentrations for the measurement of uric acid.

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 ONLY TEMPLATE

A. 510(k) Number:
k040455

B. Analyte:
Uric Acid

C. Type of Test:
Quality control material for quantitative uric acid assay

D. Applicant:
Cliniqa, Inc.

E. Proprietary and Established Names:
LiniCAL™ Uric Acid Calibration Verifiers

F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product Code:
JJX, Single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
Cliniqa LiniCAL™ 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 Uric Acid at five useful concentrations.
2. Special condition for use statement(s):
For professional prescription use only
3. Special instrument Requirements:
Olympus AU Systems

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# H. Device Description:

The LiniCAL Uric Acid Calibration Verifiers are human serum-based, containing constituents of human origin. They are used in the clinical laboratory to verify calibration and/or assess linearity of the Olympus AU Systems. Five assayed levels of uric acid are provided to allow monitoring of the reportable range.

# I. Substantial Equivalence Information:

1. Predicate device name(s):
Cliniqa LiniCAL Chemistry Calibration Verifiers, Levels A-E for Beckman Synchron Systems

2. Predicate K number(s):
k031921

3. Comparison with predicate:
Both devices are human serum-based products that are manufactured using the same processes. They differ in that the constituents in the predicate device are albumin, BUN, calcium, creatinine, lactate, magnesium, phosphorus, total protein, triglycerides, glucose, iron, sodium, potassium, and chloride, and the constituent in the subject device is uric acid.

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

None referenced.

# K. Test Principle:

Not applicable. This submission is for assayed control material.

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

1. Analytical performance:

a. Precision/Reproducibility:
Not applicable. This submission is for assayed control material.

b. Linearity/assay reportable range:
Not applicable. This submission is for assayed control material.

c. Traceability (controls, calibrators, or method):
The five levels of controls are prepared gravimetrically in a human serum-based matrix. The values are assigned using a commercially available assay. The targeted values of the five levels of controls are 3 +/- 0.300, 9.75 +/- 1.95, 16.5 +/- 3.30, 23.3 +/- 4.65, and 30.0 +/- 3.00 mg/dL.

Stability studies are described for real-time, open vial, and accelerated stability evaluation. Acceptance criteria are defined as +/- 10 % of the reference value.

d. Detection limit:
Not applicable. This submission is for assayed control material.

e. Analytical specificity:
Not applicable. This submission is for assayed control material.

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f. Assay cut-off:
Not applicable. This submission is for assayed control material.

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable. This submission is for assayed control material.
b. Matrix comparison:
Not applicable. This submission is for assayed control material.

3. Clinical studies:
a. Clinical sensitivity:
Not applicable. This submission is for assayed control material.
b. Clinical specificity:
Not applicable. This submission is for assayed control material.
c. Other clinical supportive data (when a and b are not applicable):
Not applicable. This submission is for assayed control material.

4. Clinical cut-off:
Not applicable. This submission is for assayed control material.

5. Expected values/Reference range:
Not applicable. This submission is for assayed control material.

M. Conclusion:
I recommend that the LiniCAL™ Uric Acid Calibration Verifiers are substantially equivalent to the legally marketed predicate device.