(106 days)
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No
The document describes calibration verifiers for laboratory analyzers, which are chemical reagents used to ensure the accuracy of measurements. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
No
This device is for verifying calibration and assessing linearity of laboratory analyzers, not for treating patients.
No
Explanation: This device is described as a "Calibration Verifier" intended to "verify calibration and/or assess linearity" of analyzers. It is used to monitor the reportable range of "ammonia, alcohol, microalbumin, microprotein and salicylate" on these analyzers. This indicates it is a quality control or calibrator product for laboratory instruments, not a device that directly diagnoses a disease or condition in a patient.
No
The device description is not found, but the intended use describes physical calibration verifiers (liquids) for laboratory analyzers, indicating a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in the "clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron® Analyzers." This indicates it's used to test samples in vitro (outside the body) to provide information about the performance of analytical instruments used for diagnostic purposes.
- Function: The device provides "assayed levels" of various substances (ammonia, alcohol, microalbumin, microprotein, and salicylate) to "allow monitoring of the reportable range." This means it's a control or calibrator used to ensure the accuracy and reliability of the diagnostic tests performed by the analyzers.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
CLINIQA LiniCAL™ Esoterics Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron® Analyzers. Five assayed levels of AMM (ammonia), ETOH (alcohol), MA (microalbumin), M-TP (microprotein) and SALY (salicylate) are provided to allow monitoring of the reportable range.
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
clinical laboratory
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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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure in profile.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 1 2003
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432-B South Mission Road Fallbrook, CA 92028
Re: K032074
Trade/Device Name: LiniCAL™ Esoterics Calibration Verifiers Levels A -E for Beckman Coulter Synchron ® Analyzers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 1, 2003 Received: October 3, 2003
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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
032074
Device Name: LiniCAL ™ Esoterics Calibration Verifiers Levels A – E for Beckman Coulter Synchron® Analyzers
Indications For Use:
CLINIQA LiniCAL™ Esoterics Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron® Analyzers. Five assayed levels of AMM (ammonia), ETOH (alcohol), MA (microalbumin), M-TP (microprotein) and SALY (salicylate) are provided to allow monitoring of the reportable range.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032074
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use