(33 days)
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No
The summary describes a quality control material for laboratory testing, with no mention of AI or ML capabilities or related concepts like image processing, training sets, or performance metrics associated with AI/ML.
No
The document states that this is an in-vitro diagnostic device intended for use as quality control material to monitor precision in laboratory testing, not for treating a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "in-vitro diagnostic medical devices."
No
The device is described as an in-vitro diagnostic medical device intended for use as an assayed quality control material. This description strongly suggests a physical reagent or material, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine."
This statement directly identifies the device as an in-vitro diagnostic medical device.
N/A
Intended Use / Indications for Use
The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Product codes
LAS
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
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Key Metrics
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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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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 3 1 2003
Rueyming Loor, Ph.D. Senior Director, Research and Development Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538
K030616 Re: Trade/Device Name: CEDIA® Cyclosporine Plus High Range Controls 4 and 5 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: February 25, 2003 Received: February 26, 2003
Dear Dr. Loor:
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 (OS) 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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ATTACHMENT E
INDICATIONS FOR USE STATEMENT
KO30616
510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: CEDIA® Cyclosporine Plus High Range Controls 4 and 5
Indications For Use:
The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
T. Can Cooper
(Diyision Sign-Off) Division of Clinical Laboratory De 510(k) Number --
Prescription Use X