OLYMPUS URINE CALIBRATOR

K033910 · Cliniqa Corporation · JIX · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033910
• Device Name: OLYMPUS URINE CALIBRATOR
• Applicant: Cliniqa Corporation
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea, and Total Protein on the Olympus™ series of chemistry analyzers.

Device Story

Olympus™ Urine Calibrator is an assayed, liquid, human urine-based product; supplied in 5 mL vials. Used in clinical laboratory settings to calibrate quantitative chemistry assays on Olympus series analyzers. Provides reference values for specific analytes to ensure accuracy of patient sample testing. Value assignment performed using Olympus analyzers and reagents; traceable to NIST and CAP reference materials/methods.

Clinical Evidence

No clinical data. Bench testing only; value assignment established via Olympus testing protocols using Olympus analyzers and reagents; traceability to NIST and CAP standards.

Technological Characteristics

Liquid, human urine-based calibrator. Designed for use on Olympus™ series chemistry analyzers. Standardized for specific quantitative urine chemistry assays. No electronic, software, or energy-based components.

Indications for Use

Indicated for the calibration of quantitative urine chemistry assays (Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea, Total Protein) on Olympus™ series chemistry analyzers in a clinical laboratory setting.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k033910

B. Analyte:
Calibrator

C. Type of Test:
Quantitative

D. Applicant:
Cliniqa Corporation

E. Proprietary and Established Names:
Olympus™ Urine Calibrator

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1150
2. Classification:
II
3. Product Code:
JIX
4. Panel:
75

G. Intended Use:
1. Intended use(s):
Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea Nitrogen, Uric Acid, and Urinary Total Protein on the Olympus™ series of chemistry analyzers.
2. Indication(s) for use:
Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea Nitrogen, Uric Acid, and Urinary Total Protein on the Olympus™ series of chemistry analyzers.
3. Special condition for use statement(s):
Not applicable
4. Special instrument Requirements:
Olympus™ series of chemistry analyzers

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H. Device Description:
Olympus™ Urine Calibrator is an assayed, liquid, human urine based product containing the constituents listed above. It is supplied ready-to-use in six 5 mL vials.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Urine Chemistry Standard Kit (formerly known as Multi-Chemistry Linearity Standard)
2. Predicate K number(s):
K875285
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Calibration of chemistry test systems | Calibration of chemistry test systems |
| Constituents | Calcium, creatinine, glucose, magnesium, phosphorus, urea nitrogen | Calcium, creatinine, glucose, magnesium, phosphorus, urea nitrogen |
| Form | Ready-to-use liquid | Ready-to-use liquid |
| Differences | | |
| Item | Device | Predicate |
| Constituents | Amylase, uric acid, urinary total protein | Chloride, potassium, sodium |
| Matrix | Human urine based | Aqueous based |
| Levels | 1 (single point calibrator) | 5 |

J. Standard/Guidance Document Referenced (if applicable):
None referenced

K. Test Principle:
Not applicable

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):

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The assigned values for the constituents are traceable to reference materials or methods from the National Institute of Standards and Technology (NIST) and College of American Pathologists (CAP).

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a and b are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The assigned value for each constituent has been established in accordance to Olympus testing protocols and the values are lot-specific. All values were obtained using Olympus chemistry analyzers in conjunction with their respective reagents.

M. Conclusion:
The Olympus™ Urine Calibrator is similar to the predicate device in intended use, the majority of the constituents, and form. The difference in the three constituents and base matrix do not raise new issues of safety and effectiveness. These characteristics are well-established and accepted in the scientific community. Additionally, the value assignment and stability information provided for the calibrator were adequate. I recommend a substantial equivalence determination for the Olympus™ Urine Calibrator.