K Number
K031921
Device Name
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
Date Cleared
2003-08-25

(63 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems is intended for use as an assayed quality control material for analysis.
Device Description
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More Information

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No
The summary describes a chemistry calibration verifier, which is a quality control material, and there is no mention of AI or ML in the provided text.

No.
This device is an assayed quality control material for analysis, not a therapeutic device designed to treat or alleviate a medical condition.

No
This device is a calibration verifier for quality control, not a diagnostic tool used to identify medical conditions in patients.

No

The device is described as "Chemistry Calibration Verifiers Levels A - E," which are physical materials used for calibrating laboratory instruments. This indicates a hardware component (the verifier materials themselves), not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it is "intended for use as an assayed quality control material for analysis." Quality control materials used in laboratory analysis of biological samples fall under the definition of IVDs.
  • Context: The product name "LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems" strongly suggests it's used in a clinical chemistry laboratory setting to verify the calibration of analytical instruments (Beckman Coulter Synchron Systems) that test patient samples. This is a core function within in vitro diagnostics.

While the "Device Description" is not found in the provided text, the intended use alone is sufficient to classify it as an IVD.

N/A

Intended Use / Indications for Use

LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems is intended for use as an assayed quality control material for analysis.

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

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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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.

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a symbol with three stylized, curved lines that resemble a person with outstretched arms. The symbol is surrounded by text arranged in a circular pattern. The text is small and difficult to read, but it appears to be the name of an organization or agency.

Public Health Service

AUG 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Ruggiero Director of Regulatory Affairs CLINIOA Corporation 1432 South Mission Road Fallbrook, CA 92028

K031921 Re:

Trade/Device Name: LiniCAL™ Chemistry 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: June 13, 2003 Received: June 27, 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 Sutman

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):

Device Name: LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems

Indications For Use:

LiniCAL™ Chemistry Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems is intended for use as an assayed quality control material for analysis.

Alberts Sut
Division Sign-Off for Joan Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 031921

(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