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 Description

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 (lactic acid).

AI/ML Overview

Here's an analysis of the provided text regarding the Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Blood Gas Plus CO-Oximeter 700 Series.

It's important to note that this document is a 510(k) premarket notification for a quality control material, not a medical device in the sense of an algorithm or diagnostic tool that directly analyzes patient data. Therefore, the questions related to AI, human readers, ground truth establishment for AI, and similar concepts are not directly applicable. I will address the relevant points based on the nature of the device.

Acceptance Criteria and Device Performance for Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)

1. Table of Acceptance Criteria and Reported Device Performance

The core "performance" of a quality control material is its stability and its ability to monitor the precision of an instrument. The acceptance criteria are typically related to maintaining target values and stability over time under specified storage conditions. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through stability studies.

Acceptance Criterion (Implied)	Reported Device Performance
Open Vial Stability (pH and blood gas)	Material should be sampled immediately after opening.
Open Vial Stability (CO-Oximeter, electrolytes, glucose)	Material should be sampled within 10 minutes of opening to avoid evaporation.
Unopened Vial Shelf Life (2-8°C storage)	Stable for 3 years.
Unopened Vial Room Temperature Stability (20-25°C storage)	Stable for 12 months. (Must note the date room temperature storage begins and should not be used past the overall expiration date). Avoid temperatures below 2°C or above 30°C. Do not store in direct sunlight. Real-time studies are ongoing to support this, indicating that this is the claimed intended performance.
Substantial Equivalence to Predicate Device (K002536)	Claimed via similarities in levels, form, matrix, shelf life, and open vial claim (for pH/blood gas). Differences (fill volume, room temperature storage stability, specific instrument compatibility, and one analyte exclusion) are deemed not to raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical "sample size" in terms of how many individual tests or vials were used for the stability studies. For a quality control product, this would typically involve multiple lots or batches tested over time at various intervals. The document states "Stability studies have been performed..." without quantitative details.
Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin is implicitly the USA (Bio-Rad Laboratories is based in Irvine, California). The studies described are prospective in nature, as they are "stability studies" performed to determine shelf life and open vial stability for the new device prior to its market release.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a quality control material, "ground truth" isn't established by human experts in a diagnostic sense. Instead, the "ground truth" or reference values for the control material's analytes (e.g., pH, pCO2, glucose levels) are established through manufacturing processes, assaying against known standards, and rigorous internal quality control procedures to ensure homogeneity and accurate assigned values for each level of the control. The document refers to the product as an "assayed quality control," meaning it has assigned values.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" in the context of a quality control material's stability testing. The assessment is based on objective analytical measurements and pre-defined acceptance limits for stability.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a quality control material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical, chemical quality control product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of product refers to the assigned values of the analytes (pH, pCO2, pO2, electrolytes, glucose, lactate, total hemoglobin, and hemoglobin fractions) within each level of the control material. These values are established by the manufacturer (Bio-Rad) through:

Rigorous analytical testing using reference methods and calibrated instruments.
Ensuring batch-to-batch consistency.
Determining the target range for each analyte for each level of the control.

The purpose of the control is then for laboratories to monitor their own instrument's precision against these known assigned values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this device does not utilize a "training set." The "ground truth" for the control material itself (i.e., its assigned values) is established through the described manufacturing and analytical processes.

Summary

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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 (949) 598-1200 Telephone: (949) 598-1555 Fax:

Contact Person

Elizabeth Platt RA/QA Manager Telephone: (949) 598-1285

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

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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 RadLiquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700Series)(New Device)	Bio RadLiquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer)(Predicate Device)
Similarities
Levels	Three	Three
Form	Liquid	Liquid
Matrix	Buffered bicarbonate andelectrolyte solution	Buffered bicarbonate andelectrolyte solution
Shelf Life	3 years when stored unopened at2 – 8°C	3 years when stored unopened at2 – 8°C
OpenVialClaim	Same as the predicate device.	When the control is used for pHand blood gas measurements, thematerial should be sampledimmediately after opening. Whenused only for Co-Oximeter,electrolyte, glucose or lactatemeasurements, the materialshould be sampled within 10minutes of opening to avoidevaporation. Once the control issampled, discard remainingmaterial.

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

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Differences
Intended Use	An assayed quality controlintended for use in monitoring theprecision of an individuallaboratory's measurement of pH,pCO2, pO2, electrolytes, glucose,lactate (lactic acid) totalhemoglobin, and hemoglobinfractions by blood gas, ionselective electrode (ISE),biosensor and Radiometer 700Series CO-Oximetryinstrumentation.	An assayed quality controlintended for use in monitoring theprecision of an individuallaboratory's measurement of pH,pCO2, pO2, electrolytes, glucose,lactate (lactic acid), totalhemoglobin,and hemoglobinfractions by blood gas, ionselective electrode (ISE),biosensor, and RadiometerCO-Oximetry instrumentation.
Fill Volume	1.7 mL	2.5 mL
StorageStability	12 months when stored unopenedat room temperature (20 - 25°C).	8 months when stored unopenedat room temperature (20 - 25°C).
Instrument	Made to run on the Radiometer700 Series CO-Oximetryinstrumentation.	Made to run on the RadiometerCO-Oximetry instrumentation.
ClaimedAnalytes	Same as the predicate deviceexcept for the following: VolumePercent Oxygen is not claimed onthis product.	pH, pCO2, pO2, Calcium-ionized,Chloride, Potassium, Sodium,Glucose, Lactate (Lactic Acid),Total Hemoglobin,Oxyhemoglobin, OxygenSaturation,Carboxyhemoglobin,Methemoglobin, Volume PercentOxygen, and ReducedHemoglobin

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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1. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.