(30 days)
Not Found
Not Found
No
The summary describes a reagent set for a standard laboratory assay and contains no mention of AI or ML.
No
The device is an "in vitro diagnostic" product used for the quantitative determination of alkaline phosphatase in serum, which aids in the diagnosis of certain conditions. It does not provide treatment or therapy.
Yes
The Intended Use / Indications for Use section explicitly states that the product is "to be used in a diagnostic laboratory setting" and that the determination of alkaline phosphatase is performed "for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease". The phrase "in vitro diagnostic use only" further confirms its diagnostic purpose.
No
The device description explicitly states "Liquid Alkaline Phosphatase Reagent Set," indicating a physical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the product is for the "quantitative determination of alkaline phosphatase in serum" and is "intended for in vitro diagnostic use only."
- Device Description: The "Device Description" is a "Liquid Alkaline Phosphatase Reagent Set," which is a common type of reagent used in laboratory diagnostic tests.
- Intended User / Care Setting: The intended user is "qualified laboratory technologists" in a "diagnostic laboratory setting," which is where IVD tests are typically performed.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.
Product codes
CJE
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
diagnostic laboratory setting, by qualified laboratory technologists
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
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPT. OF HEALTH & HUMAN SERVICES • USA" is arranged in a semi-circle above the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 2 1997
William F. Walters, Jr. .Vice President, Technical Operations Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
K973588 Re : Liquid Alkaline Phosphatase Reagent Set Regulatory Class: II Product Code: CJE September 19, 1997 Dated: Received: September 22, 1997
Dear Mr. Waters:
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 The general controls provisions of the Act 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 requlations 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 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlation (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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Page 1 of 1
510 (k) Number (if known): _ Unknown at this time
Device Name: Liquid Alkaline Phosphatase Reagent Set
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.
(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)
(Division Sign-Off) Division of Clinical Laborato 510(k) Number