MISSION OLYMPUS AU ISE CALIBRATORS

K071039 · Diamond Diagnostics, Inc. · JIT · Aug 8, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071039
• Device Name: MISSION OLYMPUS AU ISE CALIBRATORS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na⁺, K⁺ and Cl⁻ electrodes on the Olympus AU400 and AU600 instruments.

Device Story

Mission Olympus AU ISE Calibrators consist of aqueous solutions containing salts and preservatives. Used in clinical laboratory settings to calibrate Na⁺, K⁺, and Cl⁻ electrodes on Olympus AU400 and AU600 instruments. Calibrators ensure accuracy of electrolyte measurements by providing known reference points for the instrument's ion-selective electrode (ISE) system. No human or animal materials are present. Product is stored at 18 to 25°C with a 24-month shelf life.

Clinical Evidence

No clinical data. Performance was verified via bench testing, including accelerated stress testing for stability and side-by-side comparative testing against the predicate OEM product on the intended instruments.

Technological Characteristics

Aqueous solution of salts and preservatives; clear liquid. Packaged in plastic bottles with dropper tips. No human or animal materials. Designed for use with Olympus AU4xx and AU6xx ISE modules. Shelf life: 24 months at 18-25°C.

Indications for Use

Indicated for use as a calibration tool for Na⁺, K⁺, and Cl⁻ electrodes on Olympus AU400 and AU600 clinical chemistry instruments. Prescription use only.

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

• Olympus AU ISE Calibrators (k981743)
• Olympus AU ISE Calibrators (k961274)

Submission Summary (Full Text)

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

A. 510(k) Number:
k071039

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator for Na⁺, K⁺ and Cl⁻ for the Olympus AU400 and AU600 instruments.

D. Type of Test:
Calibration

E. Applicant:
Diamond Diagnostics Inc.

F. Proprietary and Established Names:
Mission Olympus AU ISE Calibrators

G. Regulatory Information:
1. Regulation section:
21 CFR § 862. 1150, Calibrator
2. Classification:
Class II
3. Product Code:
JIT
4. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):

Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na⁺, K⁺ and Cl⁻ electrodes on the Olympus AU400 and AU600 instruments.

2. Indication(s) for use:

See Intended use(s)

3. Special conditions for use statement(s):

Prescription Use Only

4. Special instrument requirements:

Olympus AU400 and AU600

I. Device Description:

Mission Olympus AU ISE Calibrators are aqueous solution of salts and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Olympus AU ISE Calibrators

2. Predicate K number(s):

k981743 and k961274

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Contents | Aqueous solution of salts & preservatives, Contains no human or animal materials | Aqueous solution of salts & preservatives, Contains no human or animal materials |
| Intended Use | For in-vitro diagnostics use to provide calibration for Na⁺, K⁺ and Cl⁻ electrodes | For in-vitro diagnostics use to provide calibration for Na⁺, K⁺ and Cl⁻ electrodes |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | on the Olympus AU400 and AU600 instruments | on the Olympus AU400 and AU600 instruments |
| Storage | 18 to 25°C | 18 to 25°C |

K. Standard/Guidance Document Referenced (if applicable):

Not applicable

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Reference is made to either an aqueous standard made with corresponding analyte NIST material or the Original Equipment Manufacturers (OEM) Calibrator. The calibrators' shelf-life stability are verified to be 24 months stored at room temperature.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

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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:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.