(35 days)
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No
The summary describes a calibration verifier for a laboratory instrument, which is a standard quality control material and does not mention any AI/ML components.
No
The device is described as an assayed quality control material used to verify calibration and/or assess linearity of another system, not to directly treat a medical condition.
No
The device is described as "assayed quality control material to verify calibration and/or assess linearity," which indicates it is used for quality control of another instrument, not for diagnosing patients directly.
No
The device is described as "assayed quality control material," which indicates it is a physical substance used for calibration and verification, not a software application.
Based on the provided information, the LiniCAL™ Protein 3 Calibration Verifiers Levels A – E is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the product is "intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™". This describes a product used in vitro (outside the body) to assess the performance of another diagnostic device (the Beckman-Coulter Immage™).
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific product is a quality control material, quality control materials for diagnostic tests are considered IVDs because they are essential for ensuring the accuracy and reliability of the diagnostic results.
The lack of other information like device description, image processing, AI, etc., does not negate its classification as an IVD based on the clear intended use.
N/A
Intended Use / Indications for Use
LiniCAL™ Protein 3 Calibration Verifiers Levels A – E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™
Product codes
JJY
Device Description
LiniCAL™ Protein 3 Calibration Verifiers Levels A - E for the Beckman-Coulter Immage™
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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a human profile incorporated into the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 02 2002
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQUA Corporation 1432 South Mission Road Fallbrook, CA 92028
Re: K022867
Trade/Device Name: LiniCAL™ Protein 3 Calibration Verifiers Levels A-E for Beckman Coulter Immage™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unasayed) Regulatory Class: Class I Product Code: JJY Dated: August 21, 2002 Received: August 28, 2002
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 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 (OS) 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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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/dsmaldsmamain.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): K022867
Device Name: LiniCAL ™ Protein 3 Calibration Verifiers Levels A - E for the Beckman-Coulter Immage™
Indications For Use:
LiniCAL™ Protein 3 Calibration Verifiers Levels A – E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage™
tean Cooper
(Division Sign-Off)
Division of Clinical Labora
510(k) Number K022862
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use