(14 days)
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Not Found
No
The summary describes a quantitative assay for a specific enzyme in serum, which is a standard laboratory test and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) for determining λ-GT in serum, which means it is used to analyze samples outside of the body for diagnostic purposes, not to directly treat or prevent disease in a patient.
Yes
The "Intended Use / Indications for Use" states "For IN VITRO diagnostic use," clearly indicating it is a diagnostic device.
No
The device description clearly states "Gamma-Glutamyltransferase-SL Assay," which is a laboratory assay kit used for in vitro diagnostic testing. This involves chemical reagents and potentially hardware components for analysis, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use." This is the key indicator that the device is intended for use outside of the body to diagnose conditions.
N/A
Intended Use / Indications for Use
For the quantitative determination of λ-GT in serum. For IN VITRO diagnostic use.
Product codes
JQB
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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§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(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 § 862.9.
0
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. In the center of the circle, there is a stylized image of three human profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
. . . .
Ms. Karen Callbeck, R.T., B.Sc. Requlatory Affairs Coordinator Diagnostic Division Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE, CANADA
NOV - 4 1997
Re : K974000 y-Glutamyltransferase-SL Assay, Trade Name: Cataloque Number 324-10, 324-30 Requlatory Class: I Product Code: JQB Dated: October 18, 1997 Received: October 21, 1997
Dear Ms. Callbeck:
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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 leqally 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 diaqnostic 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 qeneral 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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): | K974000 |
|---|---|
| --------------------------- | --------- |
Device Name: Gamma-Glutamyltransferase-SL Assay_______________________________________________________________________________________________________________________________
Indications For Use:
For the quantitative determination of λ-GT in serum. For IN VITRO diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
| (Optional Format 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Services | |
| 510(k) Number | K974000 |