(15 days)
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.
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.
This document describes the safety and effectiveness of the "Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)" and seeks to establish its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and the stability studies conducted. The goal is to demonstrate that the new device performs similarly to the predicate device and meets its stated stability claims.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Attributes | ||
| Levels | Three levels (consistent with predicate) | Three levels |
| Form | Liquid (consistent with predicate) | Liquid |
| Matrix | Buffered bicarbonate and electrolyte solution (consistent with predicate) | Buffered bicarbonate and electrolyte solution |
| Fill Volume | 1.7 mL (consistent with predicate) | 1.7 mL |
| Intended Use | Monitoring pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis CO-Oximetry instrumentation (similar to predicate, but specifically for IL Synthesis). | An assayed quality control to monitor 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. |
| Open Vial Stability | pH and blood gas measurements: Sample immediately after opening. CO-Oximeter, electrolyte, and glucose measurements: Sample within 10 minutes of opening to avoid evaporation. Discard remaining material. (Consistent with predicate's general guidance for these specific analytes, with lactate excluded from new device claims). | 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. |
| Unopened Vial Stability | 3 years when stored at 2 - 8°C (consistent with predicate). 6 months when stored unopened at room temperature (20 - 25°C), not used past expiration date, and avoid temperatures < 2°C or > 30°C and direct sunlight (Different from predicate's 12 months at room temperature). Real-time studies to be ongoing to support shelf life. | 3 years when stored unopened 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. 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. |
| Instrument Compatibility | Made to run on the IL Synthesis CO-Oximetry instrumentation (specific to the new device, predicate was for IL CO-Oximetry instrumentation). | Made to run on the IL Synthesis CO-Oximetry instrumentation. |
| Claimed Analytes | pH, pCO2, pO2, Calcium-ionized, Chloride, Potassium, Sodium, Glucose, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, Reduced Hemoglobin, and Oxygen Saturation (similar to predicate, but notably excluding Lactate and Volume Percent Oxygen/Oxygen Capacity, and including Oxygen Saturation). | pH, pCO2, pO2, Calcium-ionized, Chloride, Potassium, Sodium, Glucose, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, Reduced Hemoglobin, and Oxygen Saturation. |
2. Sample Size and Data Provenance (for test set)
The document states that "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)." It also mentions that "All supporting data is retained on file at Bio-Rad Laboratories."
- Sample Size: The specific sample sizes (number of vials, replicates, lots, or dates during stability studies) used for the stability testing (which serve as the "test set" for the performance claims) are not explicitly stated in the provided text.
- Data Provenance: The data provenance is from Bio-Rad Laboratories, the submitter of the device. The study is a prospective stability study conducted on the new device, designed to support its stated claims. The country of origin for the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and the submission is to the FDA.
3. Number of Experts and Qualifications (for ground truth of test set)
This device is an assayed quality control material for laboratory instruments. The "ground truth" for its performance is typically established through analytical methods and instrument readings, not expert human interpretation. Therefore, the concept of "experts" in the traditional sense (e.g., radiologists) for establishing ground truth is not applicable here.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (for test set)
Since the ground truth is established through analytical measurements and a comparison to predefined stability limits and performance metrics, an adjudication method for human interpretation is not applicable. The performance is assessed against established measurement procedures and statistical analysis of the stability data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size: Not applicable, as this is an in-vitro diagnostic control material, not a diagnostic imaging aid for human readers.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone study done? Yes, to the extent that "standalone" refers to the device itself being tested independently to determine its inherent performance characteristics (stability, analyte values on compatible instruments). The stability studies are effectively a standalone performance assessment of the control material's behavior over time and under different conditions. The "Summary of Performance Data" directly reports on the outcomes of these studies.
7. Type of Ground Truth Used
The ground truth used for this device is based on:
- Analytical Measurements/Instrument Readings: The stability studies involve repeatedly measuring the analytes (pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions) in the control material using specified instrumentation (IL Synthesis CO-Oximetry instrumentation) over time and under various storage conditions.
- Defined Chemical/Physical Properties: The control material is designed with predetermined levels of oxygen, carbon dioxide, nitrogen, and glucose, and its matrix is a buffered bicarbonate and electrolyte solution. The expected values for the analytes are what the device is "controlling" against.
- Comparison to Predicate Device: Substantial equivalence claims heavily rely on demonstrating that the new device's performance is comparable to the legally marketed predicate device, implying that the predicate's established performance serves as a reference point for acceptable ground truth.
8. Sample Size for the Training Set
This device is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable. The manufacturing process for the control material involves precise formulation and quality checks, but not algorithmic training.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device, this question is not applicable.
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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 (949) 598-1200 Telephone: Fax: (949) 598-1555
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 (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 RadLiquichek™ Blood Gas Plus CO-Oximeter Control (IL SynthesisSeries)(New Device) | Bio RadLiquichek™ Blood Gas Plus CO-Oximeter Control (IL)(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 |
| Fill Volume | 1.7 mL | 1.7 mL |
| Differences | ||
| Intended Use | An assayed quality control tomonitor the precision of anindividual laboratory'smeasurement of pH, pCO2, pO2,electrolytes, glucose, totalhemoglobin, and hemoglobinfractions by blood gas, ionselective electrode (ISE),biosensor and IL SynthesisCO-Oximetry instrumentation. | An assayed quality control tomonitor the precision of anindividual laboratory'smeasurement of pH, pCO2, pO2,electrolytes, glucose, lactate(lactic acid), total hemoglobin,and hemoglobin fractions byblood gas, ion selective electrode(ISE), IL CO-Oximetry, andbiosensor instrumentation. |
| Op n VialClaim | When the control is used for pHand blood gas measurements, thematerial should be sampledimmediately after opening. Whenused only for Co-Oximeter. | When the control is used for pHand blood gas measurements, thematerial should be sampledimmediately after opening. Whenused only for Co-Oximeter. |
Table 1. Similarities and Differences between new and predicate device.
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| electrolyte, and glucosemeasurements, the materialshould be sampled within 10minutes of opening to avoidevaporation. Once the control issampled, discard remainingmaterial. | electrolyte, glucose or lactatemeasurements, the materialshould be sampled within 10minutes of opening to avoidevaporation. Once the control issampled, discard remainingmaterial. | |
|---|---|---|
| StorageStability | 6 months when stored unopenedat room temperature (20 - 25°C). | 12 months when stored unopenedat room temperature (20 - 25°C). |
| Instrument | Made to run on the IL SynthesisCO-Oximetry instrumentation. | Made to run on the IL CO-Oximetry instrumentation. |
| ClaimedAnalytes | pH, pCO2, pO2, Calcium-ionized,Chloride, Potassium, Sodium,Glucose, Total Hemoglobin,Oxyhemoglobin,Carboxyhemoglobin,Methemoglobin, ReducedHemoglobin, and OxygenSaturation. | pH, pCO2, pO2, Calcium-ionized,Chloride, Potassium, Sodium,Glucose, Lactate (Lactic Acid),Total Hemoglobin,Oxyhemoglobin,Carboxyhemoglobin,Methemoglobin, ReducedHemoglobin, Volume PercentOxygen and Volume PercentOxygen 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:
-
- 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.
-
- 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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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 ' 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/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
§ 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.