(22 days)
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No
The document describes a quality control material for laboratory assays and makes no mention of AI or ML technology.
No
The device is described as a quality control material used in in vitro diagnostic testing to document analytical precision and instrument performance, not to treat or cure a disease or condition.
No
This device is a quality control material used to document analytical precision and reagent/instrument performance, not to diagnose a patient's condition.
No
The device is described as a "bovine based quality control material," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "quality control material for use as a consistent test sample of Known Concentrations that is assayed along with patient serum specimens when assaying for any of the listed analytes." This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description reinforces its use as a "quality control material" for "assayed along with patient serum specimens."
- Care Setting: It's intended for use in a "Clinical Laboratory," which is a typical setting for IVD testing.
The purpose of this device is to ensure the accuracy and reliability of diagnostic tests performed on patient samples. This aligns directly with the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine based quality control material for use as a consistent test sample and inimally doody the vis assayed along with patient serum specimens when of Known Concentrations that to docuyou allong on compare recovered values assaying for any of the listed ochouldents. The Gillusting analytical precision, as well as reagent and instrument performance.
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 4 1998
Scot D. Kinghorn Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technoloqy Park 542 Flynn Road Camarillo, California 93012-8058
Re : K980514 chem®TRAK Platimum Comprehensive Liquid Assayed Chemistry and TDM Control, Levels 1, 2, and 3 Regulatory Class: I Product Code: JJY February 9, 1998 Dated: Received: February 10, 1998
Dear Mr. Kinghorn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ········ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
not affect any obligation you might have under sections 531 . . through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
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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Analysis Systems, Inc 542 Flynn Road · Camarillo, CA 93012-8058 echnology Park . (805) 987-7891 · FAX: (805) 987-6498
MEDICAL ANALYSIS SYSTEMS, INC.
510(k) Notification · February 9, 1998 510(K) Notifcation > February 9, 1996
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Levels 1, 2 and 3
Statement of Indications for Use
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Chem I RAR "Haman Oompronomaterial used in various general chemistry
Control is a bovine based quality ochiler material for use as a consistent test sample and inimaliously doody the vis assayed along with patient serum specimens when of Known Concentrations that to docuyou allong on compare recovered values assaying for any of the listed ochouldents. The Gillusting analytical precision, as well as reagent and instrument performance.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K9805151