LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509

K022525 · Bio-Rad · JJS · Aug 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022525
• Device Name: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
• 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 (Radiometer 700 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, lactate (lactic acid), total hemoglobin and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.

Device Story

Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) is a liquid, dye-based, buffered bicarbonate and electrolyte solution containing pre-determined levels of oxygen, carbon dioxide, nitrogen, glucose, and lactate. It serves as an assayed quality control material for clinical laboratories to monitor the precision of blood gas, ISE, biosensor, and CO-Oximetry instrumentation. The control is provided in three levels and is intended for professional use by laboratory personnel. By measuring the control, clinicians verify the accuracy and precision of their diagnostic equipment, ensuring reliable patient test results for blood gas and metabolic analytes. The device is stored at 2–8°C or room temperature (20–25°C) and is designed for immediate use or short-term sampling after opening to prevent evaporation.

Clinical Evidence

Bench testing only. Stability studies were conducted to determine open-vial stability and shelf life. Unopened vials are stable for 3 years at 2-8°C or 12 months at room temperature (20-25°C). No clinical data was required or provided.

Technological Characteristics

Liquid, dye-based, buffered bicarbonate and electrolyte solution. Contains pre-determined levels of O2, CO2, N2, glucose, and lactate. Three-level configuration. Compatible with Radiometer 700 Series CO-Oximetry, ISE, and biosensor instrumentation. Shelf life: 3 years (2-8°C) or 12 months (20-25°C).

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory measurements of pH, blood gases, electrolytes, glucose, lactate, and hemoglobin fractions in clinical settings using Radiometer 700 Series CO-Oximetry, ISE, and biosensor 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 (Radiometer) (K002536)

Submission Summary (Full Text)

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K022525

Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Blood Gas Plus CO-Oximeter 700 Series) Levels 1, 2, and 3 Summary of Safety and Effectiveness

# Summary of Safety and Effectiveness

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)

#### 1.0 Submitter

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

### 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 (Radiometer 700 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 (Radiometer) Bio-Rad Laboratories Irvine, California

Docket Number: K002536

#### 4.0 Description of Device

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen, glucose and lactate

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(lactic acid).

#### 5.0 Statement of Intended Use

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 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, lactate (lactic acid), total hemoglobin and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.

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

The new Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) claims substantial equivalence to the Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer) currently in commercial distribution (K002536).

| Characteristics | Bio Rad<br>Liquichek™ Blood Gas Plus CO-<br>Oximeter Control (Radiometer 700<br>Series)<br>(New Device) | Bio Rad<br>Liquichek™ Blood Gas Plus CO-<br>Oximeter Control (Radiometer)<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 |
| Open<br>Vial<br>Claim | Same as the predicate device. | 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,<br>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. |

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

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| Differences | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | An assayed quality control<br>intended for use in monitoring the<br>precision of an individual<br>laboratory's measurement of pH,<br>pCO2, pO2, electrolytes, glucose,<br>lactate (lactic acid) total<br>hemoglobin, and hemoglobin<br>fractions by blood gas, ion<br>selective electrode (ISE),<br>biosensor and Radiometer 700<br>Series CO-Oximetry<br>instrumentation. | An assayed quality control<br>intended for use in monitoring the<br>precision of an individual<br>laboratory's measurement of pH,<br>pCO2, pO2, electrolytes, glucose,<br>lactate (lactic acid), total<br>hemoglobin,and hemoglobin<br>fractions by blood gas, ion<br>selective electrode (ISE),<br>biosensor, and Radiometer<br>CO-Oximetry instrumentation. |
| Fill Volume | 1.7 mL | 2.5 mL |
| Storage<br>Stability | 12 months when stored unopened<br>at room temperature (20 - 25°C). | 8 months when stored unopened<br>at room temperature (20 - 25°C). |
| Instrument | Made to run on the Radiometer<br>700 Series CO-Oximetry<br>instrumentation. | Made to run on the Radiometer<br>CO-Oximetry instrumentation. |
| Claimed<br>Analytes | Same as the predicate device<br>except for the following: Volume<br>Percent Oxygen is not claimed on<br>this product. | pH, pCO2, pO2, Calcium-ionized,<br>Chloride, Potassium, Sodium,<br>Glucose, Lactate (Lactic Acid),<br>Total Hemoglobin,<br>Oxyhemoglobin, Oxygen<br>Saturation,<br>Carboxyhemoglobin,<br>Methemoglobin, Volume Percent<br>Oxygen, and Reduced<br>Hemoglobin |

#### 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 Radiometer 700 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.

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- 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 12 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.
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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 1 5 2002

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

k022525 Re:

> Trade/Device Name: Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 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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Page 2 -

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 1 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/cdrlvdsmaldsmamain.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): K Ozzs25

Device Name:

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)

Indications for Use:

Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 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, lactate (lactic acid), total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.

Lean Cooges
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022525

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use 1 or use

Over-the Counter