MISSION COMPLETE

K060206 · Diamond Diagnostics, Inc. · JJY · Mar 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060206
• Device Name: MISSION COMPLETE
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

MISSION COMPLETE™ Linearity Control are assayed materials used for confirming the calibration and linearity of blood gas, electrolyte, and metabolite instruments for the analytes and analyzers listed on the Expected Values Chart.

Device Story

Mission Complete Linearity Controls are aqueous, buffered solutions containing electrolytes, glucose, and lactate, equilibrated with CO2, O2, and N2. The device is provided in five distinct levels to cover the significant performance range of blood gas, electrolyte, and metabolite analyzers. It is packaged in sealed 1.8 mL glass ampules for one-time use. The product contains no human or animal-derived materials. It is used in clinical laboratory settings by laboratory personnel to verify instrument calibration and linearity. By comparing analyzer results against the expected values provided for the control levels, clinicians ensure the accuracy and reliability of patient diagnostic testing, thereby supporting informed clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only, including stability testing for shelf-life claims and performance/correlation studies against the predicate device.

Technological Characteristics

Buffered aqueous solution containing electrolytes, glucose, and lactate; equilibrated with CO2, O2, and N2. No human or animal-derived materials. Form factor: 1.8 mL sealed glass ampules. Intended for one-time use. Storage: 2° - 8°C. Shelf life: 3 years.

Indications for Use

Indicated for confirming calibration and linearity of instruments measuring pH, pCO2, pO2, Na+, K+, Cl-, Glucose, and Lactate. 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

• RNA Medical CVC 123

Submission Summary (Full Text)

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K060206

510(k) Summary Pg.17 of 45 for Mission Diagnostic pH/Blood Gas ISE, Metabolite Controls for pH/Blood Gas, Electrolyte and Metabolites Analyzers

#### Submitter's Name & Address 1. Diamond Diagnostics 333 Fiske St Holliston MA 01746 FAX: [phone]

Contact Person:

And 1987 - 1997 - 1997 - 1999 -

Randolph Quinn Product Development & Compliance Manager 508-429-0450

Establishment Registration Number: 3003656721 Date of Preparation of this summary: January 18, 2006

#### 2. Identification of the Device:

| Proprietary/Trade name: | Mission Complete™ |
|-------------------------|------------------------------------------------|
| Common or usual name: | Quality Control material (assay and unassayed) |
| Classification name: | Multi-Analyte Controls (assay and unassayed) |
| Device Classification: | [ |
| Regulation Number: | 21 CFR § 862.1660 |
| Panel: | Chemistry (75) |
| Product Code: | JJY |

#### 3. Substantial Equivalence:

Mission Complete PN DD-92900 is equivalent to RNA Medical CVC 123 with regards to function, safety and efficacy.

#### Comparison Tables of Characteristics

| Characteristics | Mission | OEM Equivalent |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| PN | DD-92900 | CVC 123 |
| Contents:<br>Any Level | Aqueous solution of buffers,<br>electrolytes, glucose,<br>lactate,equilibrated with , CO2, O2,<br>and N2. Contains no human or animal<br>materials. | Aqueous solution of buffers,<br>electrolytes, glucose,<br>lactate,equilibrated with , CO2,<br>O2 and N2. Contains no<br>human or animal materials. |
| Levels | 1,2,3,4,5 | 1,2,3,4,5 |
| Container | Glass ampule | Glass ampule |
| colour | clear | clear |
| Package | 20 x 1.8 ml | 20 x 2.5 ml |
| Intended Use | For in-vitro diagnostic use only | For in-vitro diagnostic use<br>only |
| Storage | 2° - 8°C | 2° - 8°C |
| Expiration/Shelf Life | 3 years | 3 years |

#### 4. Description of the new device:

This control material is provided in five (5) distinct levels of pH, pCO2, pO2, Na *, K , Cl., Ca *, Glucose & Lactate covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in kits containing four (4) ampules of each level.

510(k) submission for Mission Diagnostics pH Blood Gas /ISE, Metabolite Controls for pH Blood Gas, Electrolyte and Metabolite Analyzers

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#### 5. Intended use of the device:

MISSION COMPLETE™ Linearity Control are assayed materials used for confirming the calibration and linearity of blood gas, electrolyte, and metabolite instruments for the analytes and analyzers listed on the Expected Values Chart.

## 6. Technological characteristics of the device:

This material consists of a buffered aqueous solution with electrolytes, glucose and lactate equilibrated with CO2, O2 and N2. The product contains no human or animal derived materials. Product is sealed into glass ampules containing 1.8mL and is intended for onetime use.

### 7. Summary of non-clinical tests submitted with the premarket notification for the device: a) Stability for shelf life claim

b) Performance & Correlation to equivalent device

- 8. Summary of clinical tests submitted with the premarket notification for the device: N/A
## 9. Conclusions drawn from the clinical and non-clinical trials:

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

510(k) submission for Mission Diagnostics pH Blood Gas /ISE, Metabolite Controls for pH Blood Gas, Electrolyte and Metabolite Analyzers

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 1 2006

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

k060206 Re: Trade/Device Name: Mission Complete™ Linearity Controls Regulation Number: 21 CFR§ 862.1660 Regulation Name: Quality Control (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 26, 2006 Received: February 15, 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 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) I ins letter will anow you to ough mains of substantial equivalence of your device to a legally promatics notification: "The PD's 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, If you desire specific mission and advertising of your device, please contact the Office of In of questions on the prometive and Safety at [phone]. Also, please note the viro Diagavitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may 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 Gutt

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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# Indications for Use

510(k) Number (if known): K060206

Mission Complete Device Name:

Indications For Use:

Mission Complete™ Linearity Controls are intended to be used for confirming the calibration and linearity of instruments measuring pH, pCO2, pO2, Na ', K ', Cr ' , CI , Glucose, and Lactate.

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)

Carol Benson

Division Sign-

Office of In Vitro Dlag Device Evaluation at

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510(k) K060206