(16 days)
Not Found
None
No
The summary describes a quantitative assay for Alkaline Phosphatase, a standard laboratory test, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
Explanation: The device is for in vitro diagnostic use, meaning it analyzes samples outside the body to diagnose conditions, and does not provide therapy or treatment.
Yes
The device is described as being for "the quantitative determination of Alkaline Phosphatase in serum" and the elevated activity of this enzyme is "of interest in the diagnosis of several disease conditions," including "hepatobiliary disease and bone disease." This directly indicates its use in aiding diagnosis.
No
The device is described as an "Alkaline Phosphatase-SL Assay" for the quantitative determination of Alkaline Phosphatase in serum, which strongly suggests it is an in vitro diagnostic (IVD) test kit involving reagents and potentially hardware for analysis, not a software-only device.
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 disease or other conditions.
N/A
Intended Use / Indications for Use
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis. (1)
Product codes
CJE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB | 2 1998
Karen Callbeck, R.T.B.Sc. . Requlatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0
Re : K980316 Alkaline Phosphatase-SL Assay Requlatory Class: II Product Code: CJE Dated: January 23, 1998 Received: January 27, 1998
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 provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 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 Reqister. 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 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 Litman
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
2
| 510(k) Number (if known): | K983016 |
|---|---|
| --------------------------- | --------- |
Device Name: Alkaline Phosphatase-SL Assay
Indications for Use:
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis. (1)
Alkaline phosphatase (AP) activity was first measured by Kay (2). Since that time many substrates such as glycerol phosphate and phenyl phosphate have been used. Bessey, Lowry, and Brock (3) introduced a more sensitive substrate p-nitrophenyl phosphate (p-NPP). Several recommendations have been made on the optimum conditions for the determination of AP in serum. These suggestions have been put forth by the German Society for Clinical Chemistry (4) as well as by the committee on enzymes of the Scandinavian Society for Clinical Chemistry (5). This method is in accordance with the recommendations of the International Federation of Clinical Chemistry (IFCC) for AP measurement in serum (6).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number A 90316
Prescription Use √
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)