MISSION CONTROLS

K033063 · Diamond Diagnostics, Inc. · JJS · Dec 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033063
• Device Name: MISSION CONTROLS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JJS · Clinical Chemistry
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas (pH, pCO2, pO2) and Electrolyte (Na, K, Cl, Li, iCa, tCO2) Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. The products encompassed are to be handled using normal laboratory precautions.

Device Story

Mission Controls are aqueous-based tonometered quality control materials; used in clinical laboratory settings to verify performance of pH/Blood Gas and Electrolyte analyzers. Device functions as a reference standard; laboratory personnel introduce control material into the analyzer; instrument measures analytes (pH, pCO2, pO2, Na, K, Cl, Li, iCa, tCO2). Output consists of measured values compared against expected ranges to estimate test imprecision and detect systematic deviations caused by instrument or reagent variation. Enables healthcare providers to ensure analytical accuracy and reliability of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted per SOP23-01-03 support a 3-year shelf life.

Technological Characteristics

Aqueous-based tonometered control material. Formulated for pH/Blood Gas and Electrolyte analyzers. No specific materials of construction or software algorithms described; device is a chemical control reagent.

Indications for Use

Indicated for use as quality control material for pH/Blood Gas and Electrolyte analyzers to monitor test imprecision and detect systematic deviations in clinical laboratory settings. Levels 1, 2, and 3 cover low, mid, and high clinical ranges; Level 4 monitors high O2 levels.

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

• ALKOntrol 1 (K950902)
• ALKOntrol 2 (K950902)
• ALKOntrol 3 (K950902)
• ALKOntrol TriLevel (K950902)
• ALKOntrol + HIGH O2 (K950902)

Submission Summary (Full Text)

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K033063

# DEC 1 2 2003

Page 25 of 33

## 510(k) Summary for Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers

| 1. | Submitter's Name & Address<br>Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: [phone] | | Contact Person<br>Linda Stundtner<br>QA/RA Manager<br>508-429-0450 |
|----|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------|
| | Establishment Registration Number: | 3003656721 | |
| | Date of Preparation: | | Sept 22, 2003 |
| | 2. Identification of the Device: | | |
| | Proprietary/Trade name: | Mission Controls™ | |
| | Common or usual name | Quality Control material (assay and unassayed) | |
| | Classification name: | Control s for Blood Gases (assay and unassayed) | |
| | Device Classification | I | |
| | Regulation Number: | 21 CFR § 862.1660 | |
| | Panel: | Chemistry (75) | |
| | Product Code: | JJS | |

### 3. Predicate Device:

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

| Mission Diagnostics | OEM Equivalent | | | | |
|---------------------|-------------------------------|------------------|----------------------|---------|------------|
| | | Predicate Device | Cleared Date | | |
| DD-92001 | Mission Control Level 1 | A700-001 | ALKOntrol 1 | | |
| DD-92002 | Mission Control Level 2 | A700-002 | ALKtOnrol 2 | K950902 | 03-30-1995 |
| DD-92003 | Mission Control Level 3 | A700-003 | ALKOntrol 3 | | |
| DD-92123 | Mission Control Level 1, 2, 3 | A700-123 | ALKOntrol TriLevel | | |
| DD-92004 | Mission Control Level 4 | A500-004 | ALKOntrol + ™HIGH O₂ | | |

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.

### 4. Device Description:

- Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
- Mission Controls are aqueous based tonometered controls .

#### Intended Use: .

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- intended for for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to . Intended for for profood Gas and Eloother to Analy 2001 instrument or reagent variation.
- Mission uses a similar composition, description and packaging as that used by the predicate � Mission uses a similar oompoomon, assistion of this submission.

### 5. Performance

- Stability studies were done per SOP23-01-03 .
- Stabilities studies support a 3 year shelf life .

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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 three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2003

Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner QA/RA Manager Mission Diagnostics 331 Fiske Street Holliston, MA 01746

Re: k033063

Trade/Device Name: Mission Diagnostic ISE pH/Blood Gas Controls for pH/BG &/or Electrolyte Analyzers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJS Dated: September 22, 2003 Received: September 29, 2003

Dear Ms. Stundtner:

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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### Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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5. New Indications of use form:

510(k( Number

K033063

# Device Name: Mission Diagnostic ISE pH/Blood Gas Controls for pH/BG &/or Electrolyte Analyzers

### Indication For Use:

- There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical . range for the analytes included in the QC. Level 4 is to check at High O2 level.
- Mission Controls are intended for six systems: .

| AVL Scientific | Ciba-<br>Coming/Bayer | IL | NOVA | Radiometer | Medica, Shapparelli,<br>Medarini |
|----------------|-----------------------|---------------------|------------------------|----------------------|---------------------------------------------------|
| 945, 947 | 238 | 1304, 1306,<br>1312 | Electrolyte<br>Systems | ABL 3, 30 | EasyLyte Na/K,<br>Na/K/Cl, Na/K/Li,<br>Na/K/Cl/Li |
| 990, 995 | 248 | BG3 | Stat Profile 1-5 | ABL 300, 330 | |
| Compact Series | 348 | BGE | | ABL 5 | |
| 982, 983, 985 | 278 | 1610, 1620 | | ABL, 50, 500,<br>520 | |
| 986 | 280 | 1630, 1640,<br>1650 | | ABL 505 | |
| 984, 987 | 288 | | | ABL 600, 610,<br>620 | |
| OMNI | 664 | | | EML-100 | |
| 9110, 9140 | 614, 644 | | | | |
| 9120, 9130 | 634 | | | | |
| 9180, 9181 | 654 | | | | |
| | 800 Series | | | | |

- The products encompassed by this request are intended for in-vitro diagnostics use and are intended for . The products encompassed by this request are intensed for Ca, Li, TOC2) Analyzers to estimate test pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
- The products encompassed are to be handled using normal laboratory precautions. .

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

Concurrance of CDRH, Office of the Device Evaluation (ODE)

Carol C. Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

/ Prescription use

510(k) k033063