LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669

K022529 · Bio-Rad · JJS · Aug 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022529
• Device Name: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
• Applicant: Bio-Rad
• Product Code: JJS · Clinical Chemistry
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is an assaved quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis CO-Oximetry instrumentation.

Device Story

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a liquid, dye-based, buffered bicarbonate and electrolyte solution containing pre-determined levels of oxygen, carbon dioxide, nitrogen, and glucose. It serves as an assayed quality control material for clinical laboratory instrumentation. Laboratory personnel use the control to monitor the precision of measurements for pH, blood gases, electrolytes, glucose, and hemoglobin fractions. The control is sampled by the instrument; the resulting measurements are compared against the control's assigned values to verify instrument performance. Proper use requires immediate sampling for pH/blood gas measurements or sampling within 10 minutes for other analytes to prevent evaporation. The device benefits patients by ensuring the accuracy and reliability of critical diagnostic test results used in clinical decision-making.

Clinical Evidence

No clinical data. Performance is supported by stability studies confirming shelf life (3 years at 2-8°C; 6 months at 20-25°C) and open-vial stability requirements.

Technological Characteristics

Liquid, buffered bicarbonate and electrolyte solution. Formulated for IL Synthesis CO-Oximetry instrumentation. Shelf life: 3 years unopened at 2-8°C or 6 months at 20-25°C. Fill volume: 1.7 mL.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory measurements of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions in clinical settings using blood gas, ISE, biosensor, and IL Synthesis CO-Oximetry instrumentation.

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

• Liquichek™ Blood Gas Plus CO-Oximeter Control (IL) (K003242)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: Fax: [phone]

## Contact Person

Elizabeth Platt RA/QA Manager Telephone: [phone]

## Date of Summary Preparation

July 24, 2002

#### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) Levels 1, 2, and 3 |
|---------------------|----------------------------------------------------------------------------------------|
| Common Name: | Controls for Blood Gases, (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJS |
| Regulation Number: | CFR 862.1660 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL) Bio-Rad Laboratories Irvine, California

Docket Number: K003242

#### 4.0 Description of Device

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose.

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#### 5.0 Statement of Intended Use

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is an assaved quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis CO-Oximetry instrumentation.

#### Comparison of the new device with the Predicate Device 6.0

The new Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) claims substantial equivalence to the Liquichek™ Blood Gas Plus CO-Oximeter Control (IL) currently in commercial distribution (K003242).

| Characteristics | Bio Rad<br>Liquichek™ Blood Gas Plus CO-<br>Oximeter Control (IL Synthesis<br>Series)<br>(New Device) | Bio Rad<br>Liquichek™ Blood Gas Plus CO-<br>Oximeter Control (IL)<br>(Predicate Device) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Levels | Three | Three |
| Form | Liquid | Liquid |
| Matrix | Buffered bicarbonate and<br>electrolyte solution | Buffered bicarbonate and<br>electrolyte solution |
| Shelf Life | 3 years when stored unopened at<br>2 - 8°C | 3 years when stored unopened at<br>2 - 8°C |
| Fill Volume | 1.7 mL | 1.7 mL |
| Differences | | |
| Intended Use | An assayed quality control to<br>monitor the precision of an<br>individual laboratory's<br>measurement of pH, pCO2, pO2,<br>electrolytes, glucose, total<br>hemoglobin, and hemoglobin<br>fractions by blood gas, ion<br>selective electrode (ISE),<br>biosensor and IL Synthesis<br>CO-Oximetry instrumentation. | An assayed quality control to<br>monitor the precision of an<br>individual laboratory's<br>measurement of pH, pCO2, pO2,<br>electrolytes, glucose, lactate<br>(lactic acid), total hemoglobin,<br>and hemoglobin fractions by<br>blood gas, ion selective electrode<br>(ISE), IL CO-Oximetry, and<br>biosensor instrumentation. |
| Op n Vial<br>Claim | When the control is used for pH<br>and blood gas measurements, the<br>material should be sampled<br>immediately after opening. When<br>used only for Co-Oximeter. | When the control is used for pH<br>and blood gas measurements, the<br>material should be sampled<br>immediately after opening. When<br>used only for Co-Oximeter. |

Table 1. Similarities and Differences between new and predicate device.

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| | electrolyte, and glucose<br>measurements, the material<br>should be sampled within 10<br>minutes of opening to avoid<br>evaporation. Once the control is<br>sampled, discard remaining<br>material. | electrolyte, glucose or lactate<br>measurements, the material<br>should be sampled within 10<br>minutes of opening to avoid<br>evaporation. Once the control is<br>sampled, discard remaining<br>material. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Storage<br>Stability | 6 months when stored unopened<br>at room temperature (20 - 25°C). | 12 months when stored unopened<br>at room temperature (20 - 25°C). |
| Instrument | Made to run on the IL Synthesis<br>CO-Oximetry instrumentation. | Made to run on the IL CO-<br>Oximetry instrumentation. |
| Claimed<br>Analytes | pH, pCO2, pO2, Calcium-ionized,<br>Chloride, Potassium, Sodium,<br>Glucose, Total Hemoglobin,<br>Oxyhemoglobin,<br>Carboxyhemoglobin,<br>Methemoglobin, Reduced<br>Hemoglobin, and Oxygen<br>Saturation. | pH, pCO2, pO2, Calcium-ionized,<br>Chloride, Potassium, Sodium,<br>Glucose, Lactate (Lactic Acid),<br>Total Hemoglobin,<br>Oxyhemoglobin,<br>Carboxyhemoglobin,<br>Methemoglobin, Reduced<br>Hemoglobin, Volume Percent<br>Oxygen and Volume Percent<br>Oxygen Capacity. |

#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series). Product claims are as follows:

- 1. Open vial: When the control is used for pH and blood gas measurements, the material should be sampled immediately after opening. When used only for CO-Oximeter, electrolyte, and glucose measurements, the material should be sampled within 10 minutes of opening to avoid evaporation. Once the control is sampled, discard remaining material.
- 2. Unopened vials of the control will be stable for 3 years when stored at 2-8°C. The control may be stored unopened at room temperature (20 to 25°C) for 6 months, but should not be used past the expiration date (note the date room temperature storage begins). Avoid exposures to temperatures 2°C or above 30°C. Do not store in direct sunlight.

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Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three parallel lines forming its body and wings.

# AUG 1 5 2002

Food and Drug Administration 098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

k022529 Re:

> Trade/Device Name: Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJS Dated: July 24, 2002 Received: July 31, 2002

Dear Ms. Platt:

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/cdrl/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 (if known): 《 02 2 52 9

Liquichek™ Blood Gas Plus Co-Oximeter Control Device Name: (IL Synthesis Series)

Indications for Use:

Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.

Ran Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022529

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use V or use

Over-the Counter