MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL

K021930 · Bionostics, Inc. · JJY · Jun 25, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021930
• Device Name: MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
• Applicant: Bionostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Medica EasyQC Blood Gas / Electrolyte Controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.

Device Story

Medica EasyQC is a three-level, non-hazardous, aqueous liquid control solution used for periodic quality assurance checks of Medica EasyStat and Medica Easy Blood Gas analyzers. The device contains clinically relevant concentrations of pH, PCO2, PO2, sodium, potassium, ionized calcium, and chloride. It is packaged in clear glass ampoules. Laboratory personnel use the control to verify the analytical performance of the analyzers; results are compared against expected values to ensure instrument accuracy and precision. The device provides a standardized method for laboratories to maintain quality control programs for blood gas and electrolyte measurements.

Clinical Evidence

No clinical data. Bench testing only, including real-time stability evaluation and precision testing.

Technological Characteristics

Buffered aqueous electrolyte solution; tonometered with carbon dioxide and oxygen gas mixtures. Three-level formulation. Packaged in 1.7 mL clear glass ampoules. Non-biological, non-hazardous. Standalone quality control material.

Indications for Use

Indicated for in vitro diagnostic use to monitor and evaluate the analytical performance of Medica EasyStat and Medica Easy Blood Gas analyzers for pH, PCO2, PO2, sodium, potassium, ionized calcium, and chloride.

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 QC623 Blood Gas and Electrolyte Control (K880447)

Submission Summary (Full Text)

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K621930

JUN 2 5 2002

# 510(k) Summary*

- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs [phone] x 220

Date of preparation of this summary: 7 June 2002

- Device trade or proprietary name: Medica EasyQC (2) Blood Gas / Electrolyte Control
## Device common or usual name or classification name:

Multi Analyte Control Solution, All Types (Assayed and Unassayed)

| PRODUCT NOMENCLATURE | CLASSIFICATION | NUMBER | CLASS | PANEL |
|------------------------------------|----------------|----------|--------|-----------|
| MULTI-ANALYTE CONTROLS – ALL KINDS | | 862.1660 | 75 JJY | CHEMISTRY |

#### (3) Substantial Equivalence

Medica EasyQC is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Medica EasyQC to predicate devices for substantial equivalency

| Characteristic | Predicate Devices | Modified Device |
|-------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Name: | RNA QC623 Blood Gas and<br>Electrolyte Control | Medica EasyQC Blood Gas /<br>Electrolyte Control |
| 510(k), Date: | K880447 | |
| Number of levels: | 3 | 3 |
| Analytes: | pH, blood gases, Na+, K+, iCa++, Cl- | pH, blood gases, Na+, K+, iCa++, Cl- |
| Container: | clear, glass ampoule | clear, glass ampoule |
| Fill volume: | 2.5 mL | 1.7 mL |
| Color: | clear | clear |
| Matrix: | Buffered, aqueous electrolyte solution<br>equilibrated with carbon dioxide and<br>oxygen gas mixture | Buffered, aqueous electrolyte solution<br>equilibrated with carbon dioxide and<br>oxygen gas mixture |

^* This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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#### (4) Description of the new device

Medica EasyQC is a specially formulated, three-level, aqueous liquid material intended for use to monitor all analytes measured by the Medica EasyStat and Easy Blood Gas analyzers. Medica EasyQC provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

Medica EasyQC contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride in three levels suitable to evaluate the measurement of the Medica EasyStat Analyzer and Medica Easy Blood Gas Analyzers.

Medica EasyQC is a non-hazardous aqueous solution containing no biological materials.

#### (5) Intended use of the device

Medica EasyQC Blood Gas/Electrolyte assayed controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.

#### (6) Technological characteristics of the device.

This material consists of buffered aqueous electrolyte solutions with clinically relevant concentrations of the targeted analytes, tonometered with precision gas mixtures of carbon dioxide and oxygen to achieve pH and blood gas values which span the range of values typical for such products with the same intended use.

#### (b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Tests were conducted to verify specific performance requirements:

- a) Real-time evaluation of products with essentially similar formulation and failure mode to support stability.
- b) Test precision

### (b) (2) Summary of clinical tests submitted with the premarket notification for the device.

N/A

#### (b) (3) 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Bockville MD 20850

## JUN 2 5 2002

Ms. Kathleen Storro Director. OA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens. MA 01432

Re: k021930

Trade/Device Name: Medica EasyOC Blood Gas/Electrolyte Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: June 7, 2002 Received: June 12, 2002

Dear Ms. Storro:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Medica EasyQC Blood Gas / Electrolyte Controls Device Name:

Indications for Use:

Medica EasyQC Blood Gas / Electrolyte Controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.

For In Vitro Diagnostic Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109) OR

Over-The-Counter Use __

(Optional Format 1-2-96)