(44 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AlkP (Alkaline Phosphatase) device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the "Performance Characteristics" section, we can infer the criteria used for substantial equivalence. The primary criterion is strong correlation and similar clinical results to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Acceptable correlation with predicate device | Correlation coefficient = 0.9981 |
| Slope of method comparison close to 1 | Slope = 1.167 |
| Y-intercept of method comparison close to 0 | Y-intercept = -2.324 U/L |
| Acceptable precision (within-run, between-run, between-day) | Total %CV for Level 1/Panel 111 = 3.8% Total %CV for Level 2/Panel 112 = 2.6% |
| Linear up to a predefined maximum concentration | Linear up to 2,000 U/L |
| Acceptable sensitivity | Sensitivity = 6 U/L |
| Overall Goal: Substantially equivalent to predicate device | "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." "Both assays yield similar clinical results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the "comparative performance studies" or "precision studies." It only refers to "two levels of control material" for precision.
The data provenance is not specified regarding country of origin. The studies appear to be retrospective in the sense that they are conducted on samples and controls to characterize the device's performance, rather than on new patient cohorts specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in vitro diagnostic assay, which measures a biochemical marker (alkaline phosphatase) in human serum or plasma. It does not involve human interpretation of images or other subjective data that would require a ground truth established by experts. The "ground truth" for this type of device is the actual concentration of the analyte, which is measured using a reference method or validated control materials.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device, as there is no subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are for the standalone performance of the AlkP assay (the device itself, which is a chemical assay run on an automated analyzer). The "algorithm" here is the chemical reaction and photometric measurement process. The "without human-in-the-loop" refers to the assay's direct measurement capability.
7. The Type of Ground Truth Used
For method comparison, the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay served as the reference standard or "ground truth" for relative performance. For precision studies, control materials with known (or established) values were used. The document implies that these control materials represented different levels of alkaline phosphatase.
8. The Sample Size for the Training Set
Not explicitly stated. For an in vitro diagnostic assay, there isn't typically a "training set" in the machine learning sense. The assay's parameters (reagent concentrations, incubation times, measurement wavelengths) are developed and optimized through R&D without a distinct "training set" as understood in AI/ML. The provided data focuses on validation (test set performance).
9. How the Ground Truth for the Training Set Was Established
Not applicable in the machine learning sense. The "ground truth" for developing and optimizing an in vitro diagnostic assay would be based on established biochemical principles, extensive laboratory testing, calibration against reference methods/materials, and analytical validation during the assay development process to ensure it accurately measures the analyte.
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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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§ 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.