(32 days)
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No
The device description details a standard enzymatic assay for measuring alkaline phosphatase activity based on a chemical reaction and absorbance measurement. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for calculating results from absorbance readings.
No.
This device is an in vitro diagnostic assay used to measure alkaline phosphatase, which aids in the diagnosis and treatment of certain diseases. It does not directly treat or prevent a disease, and therefore it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases." This indicates its role in diagnosing medical conditions.
No
The device description clearly outlines a chemical assay that involves the hydrolysis of a substrate and measurement of absorbance at a specific wavelength. This requires physical reagents and a spectrophotometer or similar hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended to measure alkaline phosphatase in serum or plasma." This is a measurement performed on a biological sample taken from the body.
- Device Description: The description clearly states it is an "in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma." It describes the chemical reaction that occurs in vitro (outside the body) to measure the analyte.
- Performance Studies: The performance studies describe comparisons with another assay and precision studies using control material, which are typical for validating an IVD.
- Predicate Device: The mention of a predicate device (K823213; Boehringer Mannheim® Alkaline Phosphatase/AMP assay) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma. the Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Product codes
75CJE
Device Description
Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET™ System. The Alkaline Phosphatase assay method comparison vielded acceptable correlation with the Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9992, slope = 1.031, and Y-intercept = 1.397 U/L. Precision studies were conducted using the Alkaline Phosphatase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 3.2% and Level 2/Panel 102 is 2.5%. The Alkaline Phosphatase assay is linear up to 8,254.6 U/L. The limit of quantitation (sensitivity) of the Alkaline Phosphatase assay is 5.7 U/L. These data demonstrate that the performance of the Alkaline Phosphatase assay is substantially equivalent to the performance of the Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient = 0.9992, slope = 1.031, and Y-intercept = 1.397 U/L.
The total %CV for Level 1/Panel 101 is 3.2% and Level 2/Panel 102 is 2.5%.
The Alkaline Phosphatase assay is linear up to 8,254.6 U/L.
The limit of quantitation (sensitivity) of the Alkaline Phosphatase assay is 5.7 U/L.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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JUN 22 1998
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 20, 1998 |
|---|---|
| Device Trade or Proprietary Name: | AlkP |
| Device Common/Usual Name or Classification Name: | Alkaline Phosphatase |
| Classification Number/Class: | 75CJE/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Test Description:
Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
Substantial Equivalence:
The Alkaline Phosphatase assay is substantially equivalent to the Boehringer Mannheim® Alkaline Phosphatase/AMP assay (K823213) on the Hitachi® 717 Analyzer for the serum or plasma applications.
Alkaline Phosphatase 510(k) May 19, 1998 AlkPhosf.lwp
Section II Page 1
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Similarities to Boehringer Mannheim:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of alkaline . phosphatase in serum or plasma.
Differences to Boehringer Mannheim:
- There is a minor difference between the assay range. .
- . The Aeroset reagent is more linear.
Intended Use:
The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Alkaline Phosphatase assay method comparison vielded acceptable correlation with the Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9992, slope = 1.031, and Y-intercept = 1.397 U/L. Precision studies were conducted using the Alkaline Phosphatase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 3.2% and Level 2/Panel 102 is 2.5%. The Alkaline Phosphatase assay is linear up to 8,254.6 U/L. The limit of quantitation (sensitivity) of the Alkaline Phosphatase assay is 5.7 U/L. These data demonstrate that the performance of the Alkaline Phosphatase assay is substantially equivalent to the performance of the Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer.
Conclusion:
Alkaline Phosphatase 510(k) May 19, 1998 AlkPhosf.lwp
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The Alkaline Phosphatase assay is substantially equivalent to the Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Alkaline Phosphatase 510(k)
May 19, 1998
AlkPhosf.lwp
Section II Page 3
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 2 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981806 Re: AlkP II Requlatory Class: Product Code: CJE Dated: May 20, 1998 May 21, 1998 Received:
Dear Mr. Littlefield:
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 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 Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.
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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/cdrh/dsmamain.html".
sincerely yours,
Steven Putman
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): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981806
(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) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
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