(26 days)
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No
The summary describes an in vitro diagnostic assay for measuring folate and contains no mention of AI or ML.
No
The device is described as "IN VITRO DIAGNOSTIC USE ONLY" for measuring folate, which indicates it is used for diagnosis and not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY".
No
The device is an in vitro diagnostic (IVD) reagent kit (AIA-PACK FOLATE) intended for use on a specific hardware analyzer (TOSOH AIA System analyzers). It is 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:
"AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers."
This statement clearly indicates that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers.
Product codes
CGN
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 10 1999
Ms. Judith E. Loebel Director of Customer Support Tosoh Medics, Inc. 347 Oyster Point Blvd. Suite 201 South San Francisco, California 94080
Re: K992365 Trade Name: AIA-PACK FOLATE Assay Regulatory Class: II Product Code: CGN Dated: July 15, 1999 Received: July 15, 1999
Dear Ms. Loebel:
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 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). 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 Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, 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 regulations.
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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/cdrls/dsmamain.html".
Sincerely yours,
Steven Sutman
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): $92365
Device Name:
Indications For Use:
AIA-PACK FOLATE
AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers.
Jean Coopy
(Division Sign-Off)
Division of Clinical Laboratory Lewees
510(k) Number K992365
(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_
(Optional Format 1-2-96)