MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)

K093384 · Diamond Diagnostics, Inc. · JJY · Mar 10, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093384
• Device Name: MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Mission Trinity R™ Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.

Device Story

Mission Trinity R is an assayed quality control material used in clinical laboratories to monitor the precision and performance of blood gas, electrolyte, metabolite, and CO-Oximeter analyzers. The device consists of a buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives, equilibrated with specific levels of CO2, O2, and N2. It is provided in three distinct levels in sealed 1.8 ml glass ampules. Laboratory technicians use the control by running it through the analyzer as a sample; the analyzer measures the analytes and compares the results against the provided Expected Values Chart. This process allows the healthcare provider to verify the accuracy and reliability of the instrumentation, ensuring that patient test results are precise and clinically valid. The device contains no human or biological materials.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives. Equilibrated with CO2, O2, and N2. Packaged in 1.8 mL sealed glass ampules. Three levels provided. Storage at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the precision and performance of blood gas, electrolyte, metabolite, and CO-Oximeter analyzers. No specific patient population is described as the device is a laboratory quality control material.

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.

Predicate Devices

• RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-OXimeter (Radiometer) Control (K880447)

Submission Summary (Full Text)

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## ் 510(k) Summary

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

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| The Assigned 510(k) Number is: k093384<br>Applicant: | Diamond Diagnostics, Inc.<br>333 Fiske Street<br>Holliston, MA 01746 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Kathy Cruz<br>Qaulity Assurance Manager<br>Phone: [phone] ext. 358<br>Fax: [phone] |
| Date Prepared: | March 4, 2010 |
| Controls: | |
| Classification Name: | Controls for blood-gases (Assayed and Un-Assayed) |
| Trade Name: | Mission Trinity R |
| Device Classification: | 21 CFR 862.1660 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JJY |

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| Intended Use: | Mission Trinity R TM Control is intended to be used as an assayed quality control<br>material for monitoring the precision and performance of the following analytes pH, pCO2,<br>pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite<br>analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-<br>Oximeter instrumentation. It is for <i>in vitro</i> diagnostics use and for the quantitative<br>determination of the analytes listed on the Expected Values Chart. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and<br>preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no<br>human or biological materials. Trinity R is provided in three (3) distinct levels of pH,<br>pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb,<br>%MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It<br>is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are<br>packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules<br>of each level). |
| Predicate Device name: | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-OXimeter (Radiometer)<br>Control |
| Predicate 510(k) number(s): | K880447 |

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Comparison with predicate:

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| Similarities | | |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Characteristics | Mission Trinity R | RNA Medical RA 525 Blood Gas,<br>Electrolyte, Metabolite, CO-OXimeter<br>(Radiometer) |
| 510(K) Number | K093384 | K880447 |
| Product Type | Assayed Blood Gas Control | Assayed Blood Gas Control |
| Intended Use | For <i>in vitro</i> diagnostics use for quality control<br>of pH/Blood Gas analyzers, ISE analyzers,<br>Metabolite analyzers and CO-OXimeter<br>Instrumentation. | Same |
| Matrix | Buffered Aqueous Solution | Same |
| Storage | 2-8°C | Same |
| Color | Red/purple solution | Same |
| Levels | Three | Same |
| Analytes | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,<br>lactate, tHb, %O2Hb, %COHb, %metHb,<br>%O2Ct, %O2Sat and %HHb | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,<br>lactate, tHb, %O2Hb, %COHb, %metHb,<br>%O2Ct, %O2Sat and %HHb |

| Differences | | |
|-----------------|-------------------|---------------------------------------------------------------------------------------|
| Characteristics | Mission Trinity R | RNA Medical RA 525 Blood Gas,<br>Electrolyte, Metabolite, CO-OXimeter<br>(Radiometer) |
| Preservative | Present | Not present |
| Package | 30 X 1.8mL | 30 X 2.5mL |
| Shelf Life | 24 months | 36 months |

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Mission claims substantial equivalence to RNA Medical RA525 Controls listed below:

#### Substantial Equivalence Table of Product PN's & Trade Names

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| Mission Product | | RNA Medical RA 525 | |
|-----------------|-----------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------|
| DD-97001D | Mission Trinity R Control (Level 1) | RA 525-1 | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 1) |
| DD-97002D | Mission Trinity R Control (Level 2) | RA 525-2 | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 2) |
| DD-97003D | Mission Trinity R Control (Level 3) | RA 525-3 | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 3) |
| DD-97123 | Mission Trinity R Control (Multi-Level) | RA 525 | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Multi-Level) |

Mission claims substantial equivalence to RNA Medical RA525 for Composition, Intended use, Packaging, Storage, and Shelf life.

The tables below compare Mission to RNA Medical RA525.

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### Comparison Tables of Characteristics - Mission vs RNA Medical - by product

| Characteristics | Mission Trinity R | RNA Medical RA 525 Blood Gas,<br>Electrolyte, Metabolite, CO-OXimeter<br>(Radiometer) k880447 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Type | Assayed Blood Gas Control | Assayed Blood Gas Control |
| Intended Use | For in vitro diagnostics use for quality control<br>of pH/Blood Gas analyzers, ISE analyzers,<br>Metabolite analyzers and CO-OXimeter<br>Instrumentation. | For in vitro diagnostics use for quality<br>control of pH/Blood Gas analyzers, ISE<br>analyzers, Metabolite analyzers and CO-<br>Oximeter Instrumentation. |
| Matrix | Buffered Aqueous Solution | Buffered Aqueous Solution |
| Storage | 2-8°C | 2-8°C |
| Color | Red/purple solution | Red/purple solution |
| Levels | 1, 2, 3 | 1, 2, 3 |
| Analytes | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,<br>lactate, tHb, %O2Hb, %COHb, %metHb,<br>%O2Ct, %O2Sat and %HHb | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,<br>lactate, tHb, %O2Hb, %COHb, %metHb,<br>%O2Ct, %O2Sat and %HHb |
| Preservative | Present | Not present |
| Package | 30 X 1.8mL | 30 X 2.5mL |
| Shelf Life | 24 months | 36 months |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Diamond Diagnostics Inc. c/o Kathy Cruz 333 Fiske Street Holliston, Massachusetts 01746

MAR 1 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: k093384

> Trade Name: Mission Trinity R Blood Gas Controls Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Assayed and Unassayed. Regulatory Class: Class I, reserved Product Codes: JJY Dated: January 4, 2010 Received: January 4, 2010

Dear Ms. Cruz:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cfa

Courtney C. Harper, Ph.D. 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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. Indications for Use 510(k) Number (if known): K093384

Device Name: __ Mission Trinity R_

Indications for Use:

Mission Trinity R™ Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na*, K*, Ca**, Cn, glucose, and lactate on blood gas,
electrolyte, and metabolite analyzers as well as tHb, %OJ-Kb, Oximeter instrumentation.

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 OF NEEDED)

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

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093384

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