(15 days)
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No
The device is a quality control solution for laboratory instruments, not a diagnostic or analytical device that would typically incorporate AI/ML. The description focuses on the chemical composition and stability of the control material.
No
This device is a quality control material intended for monitoring the precision of laboratory measurements, not for treating any medical condition.
No
This device is a quality control material intended to monitor the precision of laboratory measurements, not to diagnose a patient's condition directly.
No
The device description clearly states it is a "dye based, buffered bicarbonate and electrolyte solution," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "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." This describes a product used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details a "dye based, buffered bicarbonate and electrolyte solution" which is a reagent or material used in laboratory testing.
- Quality Control: The term "quality control" is a key indicator of an IVD. Quality control materials are used to ensure the accuracy and reliability of diagnostic tests.
Therefore, based on the provided information, the Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JJS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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
1
(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
Liquichek™ Blood Gas Plus CO-
Oximeter Control (Radiometer 700
Series)
(New Device) | Bio Rad
Liquichek™ Blood Gas Plus CO-
Oximeter Control (Radiometer)
(Predicate Device) |
|-----------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Levels | Three | Three |
| Form | Liquid | Liquid |
| Matrix | Buffered bicarbonate and
electrolyte solution | Buffered bicarbonate and
electrolyte solution |
| Shelf Life | 3 years when stored unopened at
2 – 8°C | 3 years when stored unopened at
2 – 8°C |
| Open
Vial
Claim | Same as the predicate device. | 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, glucose or lactate
measurements, the material
should be sampled within 10
minutes of opening to avoid
evaporation. Once the control is
sampled, discard remaining
material. |
Table 1. Similarities and Differences between new and predicate device.
2
| Differences | ||
|---|---|---|
| Intended Use | 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. | 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 | ||
| CO-Oximetry instrumentation. | ||
| Fill Volume | 1.7 mL | 2.5 mL |
| Storage | ||
| Stability | 12 months when stored unopened | |
| at room temperature (20 - 25°C). | 8 months when stored unopened | |
| at room temperature (20 - 25°C). | ||
| Instrument | Made to run on the Radiometer | |
| 700 Series CO-Oximetry | ||
| instrumentation. | Made to run on the Radiometer | |
| CO-Oximetry instrumentation. | ||
| Claimed | ||
| Analytes | Same as the predicate device | |
| except for the following: Volume | ||
| Percent Oxygen is not claimed on | ||
| this product. | pH, pCO2, pO2, Calcium-ionized, | |
| Chloride, Potassium, Sodium, | ||
| Glucose, Lactate (Lactic Acid), | ||
| Total Hemoglobin, | ||
| Oxyhemoglobin, Oxygen | ||
| Saturation, | ||
| Carboxyhemoglobin, | ||
| Methemoglobin, Volume Percent | ||
| Oxygen, and Reduced | ||
| 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:
-
- 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.
3
-
- 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.
- 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.
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:
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