(28 days)
Not Found
Not Found
No
The document describes a quality control material for a laboratory immunoassay, with no mention of AI or ML in the provided sections.
No
The device is described as a quality control material to verify calibration and assess linearity, which indicates it is used for diagnostic accuracy rather than therapeutic intervention.
No
The device is described as an "assayed quality control material to verify calibration and/or assess linearity." This indicates it's used to check the performance of other devices (like analytical instruments), not to directly diagnose a condition in a patient.
No
The device is described as "assayed quality control material," which implies a physical substance used for calibration, not software.
Based on the provided information, the LiniCAL™ hsCRP Calibration Verifiers Levels A - E is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is "intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage TM". Quality control materials used to verify the performance of diagnostic tests are considered IVDs.
- Nature of the Device: It is a calibration verifier for a diagnostic instrument (Beckman-Coulter Immage TM), which is used to perform in vitro diagnostic tests.
While the "Device Description" is not found, the intended use alone is sufficient to classify it as an IVD.
N/A
Intended Use / Indications for Use
LiniCAL™ hsCRP 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 TM
Product codes
JJY
Device Description
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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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three abstract human profiles facing right. The profiles are stacked vertically, with the top one being the largest and the bottom one the smallest. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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: K022936
Trade/Device Name: LiniCAL™ hsCRP 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: September 3, 2002 Received: September 4, 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 mear. 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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): K022936
Device Name: LiniCAL™ hsCRP Calibration Verifiers Levels A -- E for Beckman Coulter Immage™
Indications For Use:
LiniCAL™ hsCRP 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 TM
Leann Cooper
(Division
Divi
510(k) Number K022936
(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)
ଠାର
Over-The-Counter Use