← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K071039

# MISSION OLYMPUS AU ISE CALIBRATORS (K071039)

_Diamond Diagnostics, Inc. · JIT · Aug 8, 2007 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K071039

## Device Facts

- **Applicant:** Diamond Diagnostics, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Aug 8, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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.

## Regulatory 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)

{1}

2

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  |

{2}

|  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:

{3}

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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K071039](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K071039)

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