(27 days)
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No
The summary describes liquid quality control products for laboratory analyzers and does not mention any AI or ML components.
No
The product is described as a quality control product used to evaluate the performance of laboratory systems, not to treat or diagnose patients.
No
Explanation: The device is described as "assayed, liquid, quality control products" used to evaluate the performance of a system (Beckman Coulter Synchron® System) for certain analytes, not to directly diagnose a patient's condition. It's a quality control product, not a diagnostic one.
No
The device description explicitly states it is "assayed, liquid, quality control products," indicating a physical, liquid substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is used to "evaluate the performance of the Beckman Coulter Synchron® System" for various enzyme tests. This means it's used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic test.
- Device Description: The description "assayed, liquid, quality control products" further supports its role in the diagnostic process. Quality control materials are essential for ensuring the validity of diagnostic test results.
Therefore, based on the provided information, the CLINIQA LiniCAL™ Enzyme Calibration Verifiers are indeed IVD devices.
N/A
Intended Use / Indications for Use
CLINIQA LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.
Product codes
JJY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.
Public Health Service
MAR 2 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIOA Corporation 1432 South Mission Rd. Fallbrook, CA 92028
Re: K040535
Trade/Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: March 1, 2004 Received: March 2, 2004
Dear Ms. Ruggiero:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K040535 510(k) Number (if known):
Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems
Indications For Use:
CLINIQA LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qeet. D. Heen and for Heen Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040535
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use