(15 days)
Not Found
No
The summary describes a quality control solution for laboratory instruments, not a device that processes data or images using AI/ML. The "Not Found" entries for AI/ML mentions and training/test sets further support this.
No
This device is a quality control material used to monitor the precision of laboratory instruments, not to diagnose, treat, or prevent disease in a patient.
No
This device is a quality control material used for monitoring the precision of analytical instruments (blood gas, ISE, biosensor, and co-oximetry). It does not directly diagnose a patient's condition.
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 is for "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." This indicates it is used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description of the control material as a "dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose" further supports its use as a control for in vitro diagnostic instruments.
- Quality Control: The term "quality control" is a key indicator of an IVD. Quality controls are used to ensure the accuracy and reliability of diagnostic tests performed in vitro.
Therefore, based on the provided information, the Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is an assay ed 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.
Product codes (comma separated list FDA assigned to the subject device)
JJS
Device Description
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.
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
individual laboratory's
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 (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.
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.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
Liquichek™ Blood Gas Plus CO-
Oximeter Control (IL Synthesis
Series)
(New Device) | Bio Rad
Liquichek™ Blood Gas Plus CO-
Oximeter Control (IL)
(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 |
| Fill Volume | 1.7 mL | 1.7 mL |
| Differences | | |
| Intended Use | 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. | An assayed quality control to
monitor 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), IL CO-Oximetry, and
biosensor instrumentation. |
| Op n Vial
Claim | 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. | 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. |
Table 1. Similarities and Differences between new and predicate device.
2
| | 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. | 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. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Storage
Stability | 6 months when stored unopened
at room temperature (20 - 25°C). | 12 months when stored unopened
at room temperature (20 - 25°C). |
| Instrument | Made to run on the IL Synthesis
CO-Oximetry instrumentation. | Made to run on the IL CO-
Oximetry instrumentation. |
| Claimed
Analytes | pH, pCO2, pO2, Calcium-ionized,
Chloride, Potassium, Sodium,
Glucose, Total Hemoglobin,
Oxyhemoglobin,
Carboxyhemoglobin,
Methemoglobin, Reduced
Hemoglobin, and Oxygen
Saturation. | pH, pCO2, pO2, Calcium-ionized,
Chloride, Potassium, Sodium,
Glucose, Lactate (Lactic Acid),
Total Hemoglobin,
Oxyhemoglobin,
Carboxyhemoglobin,
Methemoglobin, Reduced
Hemoglobin, Volume Percent
Oxygen and Volume Percent
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:
-
- 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.
3
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.
4
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