(44 days)
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No
The device description and performance studies describe a standard in vitro diagnostic assay based on enzymatic reaction and spectrophotometry, with no mention of AI or ML.
No
This device is an in vitro diagnostic assay used to measure alkaline phosphatase, which aids in the diagnosis and treatment of diseases, but it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases." This directly indicates its role in diagnosis.
No
The device description clearly describes a chemical assay that measures alkaline phosphatase activity through a colorimetric reaction, indicating it is a reagent-based in vitro diagnostic device, 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" section explicitly states that the assay 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 "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma." The term "in vitro" means "in glass" or "in the lab," indicating that the test is performed outside of the living organism.
- Purpose: The measurement of alkaline phosphatase is used "in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases." This directly relates to providing information for medical diagnosis and treatment, which is a core function of IVDs.
The entire description aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfusions, or to monitor therapeutic measures.
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
CJE
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 serum 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 405 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 ALCYON™ Analyzer. The Alkaline Phosphatase assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay. The correlation coefficient = 0.9981, slope = 1.167, and Y-intercept = - 2.324 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 111 is 3.8% and Level 2/Panel 112 is 2.6%. The Alkaline Phosphatase assay is linear up to 2,000 U/L. The sensitivity of the Alkaline Phosphatase assay is 6 U/L. These data demonstrate that the performance of the Alkaline Phosphatase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9981, slope = 1.167, Y-intercept = - 2.324 U/L. total %CV for Level 1/Panel 111 is 3.8% and Level 2/Panel 112 is 2.6%. linear up to 2,000 U/L. sensitivity is 6 U/L.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
MAY 2 0 1998
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | April 3, 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 serum 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 405 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 Roche® Cobas Mira® Plus Automated Chemistry System Alkaline Phosphatase assay (K902560). Both assays are in vitro clinical chemistry methods. Both assays can be used for the
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quantitative determination of Alkaline Phosphatase in human serum. Both assays yield similar clinical results.
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 ALCYON™ Analyzer. The Alkaline Phosphatase assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay. The correlation coefficient = 0.9981, slope = 1.167, and Y-intercept = - 2.324 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 111 is 3.8% and Level 2/Panel 112 is 2.6%. The Alkaline Phosphatase assay is linear up to 2,000 U/L. The sensitivity of the Alkaline Phosphatase assay is 6 U/L. These data demonstrate that the performance of the Alkaline Phosphatase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay.
Conclusion:
The Alkaline Phosphatase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay as demonstrated by results obtained in the studies.
Alkaline Phosphatase 510(k) April 3, 1998 AlkPhosE2Jwp
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 0 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981245 Re : AlkP Requlatory Class: II Product Code: CJE Dated: April 3, 1998 Received: April 6, 1998
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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as setforth 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 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 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 Butman
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: Alkaline Phosphatase
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.
(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 Laboratory Devices
510(k) Number. K981245
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