(33 days)
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No
The document describes a calibration verification material for a laboratory instrument and contains no mention of AI or ML.
No.
The device is described as an assayed quality control material for verifying calibration and assessing linearity of a diagnostic immunoassay system. It does not treat or diagnose a disease.
No.
The device is a quality control material used to verify calibration and assess linearity of an immunoassay system, not to diagnose medical conditions in patients.
No
The device description clearly states "LiniCAL™ Protein 4 Calibration Verifiers Levels A-E", which are physical calibration materials, not software.
Based on the provided information, the LiniCAL™ Protein 4 Calibration Verifiers Levels A – E is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's 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.
- Device Description: The description confirms it's a "Calibration Verifiers" product, which aligns with the quality control function described in the intended use.
IVD devices are products used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. While this specific product isn't directly testing a patient sample, it's a critical component used with an IVD device (the Beckman-Coulter Immage™) to ensure its accuracy and reliability in performing those diagnostic tests. Therefore, it falls under the scope of IVD regulation.
N/A
Intended Use / Indications for Use
LiniCAL™ Protein 4 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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its head and neck. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQUA Corporation 1432 South Mission Road Fallbrook, CA 92028
OCT 02 2002
K022885 Re:
Trade/Device Name: LiniCALTM Protein 4 Calibration Verifiers Levels A-E for Beckman Coulter Immage™M Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unasayed) Regulatory Class: Class I Product Code: JJY Dated: August 28, 2002 Received: August 30, 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 (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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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): K022885
Device Name: LiniCAL ™ Protein 4 Calibration Verifiers Levels A - E for Beckman Coulter Immage™
1000 - 1000
Indications For Use:
.
LiniCAL™ Protein 4 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™
Fran Cooper
(Divisi
Divisi
K022885
510(k)
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
scription Use _
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
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