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

Intended 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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## Diamond Diagnostics 510(k) Submission for Olympus AU ISE Calibrators

# 4. 510(k) Summary

### Owner's Name & Address:

Diamond Diagnostics Inc 333 Fiske Street Holliston MA 01746 FAX: [phone]

Establishment Registration Number: 3003030793

#### Date of Preparation: Identification of the Device:

April 10, 2007

Contact Person:

Kathryn Thorsen

508-429-0450 x357

Quality Assurance Manager

Proprietary/Trade name: Mission Olympus AU ISE Calibrators Common name Calibrating Standard Classification name: Calibrator, Secondary (21 CFR 862.1150, Product Code JIT). The product code of JIT has been assigned to this device in the Classification Database.

### Substantial Equivalence Table of Product Part Numbers & Trade Names

| Diamond/Mission Product | Olympus Equivalent |
|-------------------------------------|---------------------------------|
| OY-AUH1012D ISE Mid Standard | AUH1012 ISE Mid Standard |
| OY-AUH1014D ISE Low Standard | AUH1014 ISE Low Standard |
| OY-AUH1015D ISE High Standard | AUH1015 ISE High Standard |
| OY-AUH1016D Low/High Urine Standard | AUH1016 Low/High Urine Standard |

### Description of Device:

Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators.

#### Intended Use:

Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments.

| Characteristics | Mission Olympus AU ISE Calibrators | Olympus AU ISE Calibrators |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PN | OY-AUH1012D, OY-AUH1014D, OY-AUH1015D,<br>OY-AUH1016D | AUH1012, AUH1014, AUH1015, AUH1016 |
| Contents: | Aqueous solution of salts & preservatives<br>Contains NO human or animal materials. | Aqueous solution of salts & preservatives<br>Contains NO human or animal materials. |
| Container | Plastic bottles | Plastic bottles |
| Color | Clear solution | Clear solution |
| Package | OY-AUH1012D: 4 x 2L bottles in corrugated box,<br>OY-AUH1014D & OY-AUH1015D: 4 X 100mL<br>bottles with dropper tips & caps in corrugated box,<br>OY-AUH1016D: 2 x 100mL Low Urine Standard<br>(OY-AUH1016AD) & 2 x 100mL High Urine<br>Standard (OY-AUH1016BD) all in plastics bottles<br>with dropper tips & caps in corrugated box | AUH1012: 4 x 2L bottles in corrugated box,<br>AUH1014 & AUH1015: 4 X 100mL bottles with<br>dropper tips & caps in corrugated box, AUH1016:<br>2 x 100mL Low Urine Standard & 2 x 100mL High<br>Urine Standard all in plastics bottles with dropper<br>tips & caps in corrugated box |
| Intended Use | For in-vitro diagnostics use to provide calibration<br>points for Na+, K+ and Cl- electrodes on the<br>Olympus AU4xx and AU6xx instruments. | For in-vitro diagnostics use to provide calibration<br>points for Na+, K+ and Cl- electrodes on the<br>Olympus AU4xx and AU6xx instruments. |
| Storage / Shelf<br>Life | 18-25°C 24-months | 18-25°C 24-months |

### Technological Characteristics:

K071039

AUG - 8 2007

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K071039

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## Assessment of Non-Clinical Performance Data:

Tests were conducted to verify specific performance requirements:

- Accelerated (high temperature) stress test to support stability a.
Alian (ti
- Side by side testing of Mission Olympus AU ISE Calibrators vs. Predicate (OEM) product on intended b. instruments to demonstrate equivalence

#### Assessment of Clinical Performance Data: NA

### Conclusions:

Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diamond Diagnostics Inc. c/o Ms. Kathryn Thorsen Quality Assurance Manager 333 Fiske Street Holliston, MA 01746

AUG - 8 2007

Re: k071039 Trade/Device Name: Mission Olympus AU ISE Calibrators Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 22, 2007 Received: June 25, 2007

Dear Ms. Thorsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### 4. Indications for Use Statement

510(k) Number (if known): K071039

Device Name: Mission Olympus AU ISE Calibrators

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.

For In Vitro Diagnostic Use

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

§10(k) k071039