MISSION TRINITY B

K062674 · Diamond Diagnostics, Inc. · JJY · Dec 1, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062674
• Device Name: MISSION TRINITY B
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Mission Trinity B blood gas, electrolyte, metabolite, CO-Oximeter control is an assayed quality control material used for monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Bayer 270/800/400 series) instrumentation for the analytes listed on the Expected Values Chart.

Device Story

Mission Trinity B is a three-level aqueous quality control material; contains buffers, electrolytes, glucose, lactate, and dyes equilibrated with CO2, O2, and N2 to simulate clinical values for hemoglobin and derivatives. Used in clinical laboratories to perform periodic QC checks on Bayer 270/800/400 series analyzers. Provided in heat-sealed glass ampules. Healthcare providers use the control to verify instrument performance; results are compared against expected values to ensure accuracy of patient testing. No human or animal materials are used.

Clinical Evidence

No clinical data. Performance verified via bench testing, including accelerated high-temperature stress tests for stability and side-by-side comparative testing against the predicate device on intended instrumentation.

Technological Characteristics

Aqueous solution of buffers, electrolytes, glucose, lactate, and dyes; equilibrated with CO2, O2, and N2. Form factor: 1.8mL glass ampule (heat-sealed, score-break). Storage: 2-8°C or 18-25°C. Contains no human or animal materials. Standalone control material; no software or connectivity.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb, and %HHb on Bayer blood gas, electrolyte, metabolite, and CO-Oximetry analyzers. For in vitro diagnostic use.

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

• Bayer Rapid Complete (108860, 108868, 108869)

Submission Summary (Full Text)

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K062674

# 5. 510(k) Summary

# Owner's Name & Address:

Diamond Diagnostics Inc 333 Fiske Street Ho!liston MA 01746 FAX: [phone]

Establishment Registration Number: 3003030793

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

DEC - 1 2006

Contact Person: Randolph Quinn Development & Compliance Manager 508-429-0450 (x318)

September 1, 2006

Proprietary/Trade name: Mission Trinity B Common name blood gas controls with electrolytes, glucose and dyes Classification name: controls for blood-gases (assayed and un-assayed) (Classification # 862.1660, Product Code JJY)

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

| Diamond/Mission Product | Bayer Equivalent |
|-----------------------------------|---------------------------------|
| DD-96001 Trinity B Level 1 | 108860 Rapid Complete Level 1 |
| DD-96002 Trinity B Level 2 | 108868 Rapid Complete Level 2 |
| DD-96003 Trinity B Level 3 | 108869 Rapid Complete Level 3 |
| DD-96123 Trinity B Levels 1,2,3 | Not available |

### Description of New Device:

Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program.

Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.

#### Intended Use:

Mission Trinity B blood gas, electrolyte, metabolite, CO-Oximeter control is an assayed quality control material used for monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Bayer 270/800/400 series) instrumentation for the analytes listed on the Expected Values Chart.

### Comparison of Technological Characteristics with Predicate Device:

| Characteristics | Mission Trinity B | Bayer Rapid Complete |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| PN | DD-96001, 96002, 96003, 96123 | 108860, 108868, 108869 |
| Contents:<br>Any Level | Aqueous solution of buffers, electrolytes, glucose, lactate, dyes, equilibrated with CO2, O2 and N2.<br>Contains NO human or animal materials. | Aqueous solution of buffers, electrolytes, glucose, lactate, dyes, equilibrated with CO2, O2 and N2.<br>Contains NO human or animal materials. |
| Container | Glass ampule (heat sealed, score break) | Glass ampule (heat sealed, score break) |
| Color | Red/purple solution | Red/purple solution |
| Package | 30 X 1.8mL (instrument only requires a fraction a<br>of an mL to make a measurement) | 30 X 2.5mL |
| Intended Use | For in-vitro diagnostics use for quality control of<br>pH/Blood Gas analyzers, ISE analyzers, CO-<br>oximeters, and Metabolite analyzers. | For in-vitro diagnostics use for quality control of<br>pH/Blood Gas analyzers, ISE analyzers, CO-<br>oximeters, and Metabolite analyzers. |
| Storage / Shelf<br>Life | 2-8°C (36-months) or 18-25°C 12-months | 2-8°C or 18-25°C (until expiration date) |

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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 #
- Side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o 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 a black and white logo. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Randolph Quinn Development & Compliance Manager Diamond Diagnostics Inc. 333 Fiske Street Holliston, MA 01746

DEC - 1 2006

k062674 Re: Trade/Device Name: Mission Trinity B Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 1, 2006 Received: September 8, 2006

Dear Mr. Quinn:

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 dcvices 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 adultcration.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Gutierrez, 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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cc: HFZ-401 DMC
D.O.

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## 4. Indications for Use Statement

510(k) Number (if known):
K062674

Device Name: Mission Trinity B

Indications For Use:

Mission Timity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation.

For In Vitro Diagnostic Use

Prescription Use _ X (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)

Carol C Benson

vision Sign-Off

Office of In Vitro Diagnostic Device

K 062674

Diamond Diagnostics 510(k) Submission for Trinity B Controls