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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the K981806 device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, the Boehringer Mannheim® Alkaline Phosphatase/AMP assay (K823213) on the Hitachi® 717 Analyzer. The study aims to show that the new Abbott AlkP assay performs similarly to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Abbott AlkP)
Correlation with Predicate	High correlation coefficient with the predicate device.	Correlation coefficient = 0.9992 with the Boehringer Mannheim assay on the Hitachi 717 Analyzer.
Slope	Slope close to 1.0 when compared to the predicate.	Slope = 1.031
Y-intercept	Y-intercept close to 0 when compared to the predicate.	Y-intercept = 1.397 U/L
Precision (Within-run %CV)	Acceptable within-run precision.	Not explicitly stated as a separate criterion, but included in total %CV.
Precision (Between-run %CV)	Acceptable between-run precision.	Not explicitly stated as a separate criterion, but included in total %CV.
Precision (Between-day %CV)	Acceptable between-day precision.	Not explicitly stated as a separate criterion, but included in total %CV.
Total Precision (%CV)	Acceptable total precision for control materials.	Deducible from the total %CV: Level 1/Panel 101 is 3.2%, Level 2/Panel 102 is 2.5%.
Linearity Range	Acceptable linearity range.	Linear up to 8,254.6 U/L.
Limit of Quantitation (Sensitivity)	Acceptable sensitivity.	5.7 U/L.
Assay Range	Similar assay range to the predicate.	Minor difference in assay range compared to Boehringer Mannheim (no specific values given).
Linearity (Comparison)	Improved or comparable linearity to the predicate.	The Aeroset reagent (used in Abbott AlkP) is "more linear" than the predicate.

Study Details:

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated. The document mentions "comparative performance studies" and "precision studies" using "two levels of control material" but does not specify the number of patient samples or replicates used for these tests.
- Data provenance: Not explicitly stated, though it's an in vitro diagnostic assay for human serum or plasma. The country of origin is not mentioned, and it is a prospective study as these are performance characteristics being evaluated for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For an in vitro diagnostic assay like Alkaline Phosphatase, ground truth is typically established by reference methods or validated calibrated instruments/materials, not by expert interpretation in the same way it would be for imaging diagnostics. The comparison is against a legally marketed predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a quantitative chemical assay, not an interpretation task requiring adjudication.
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 and does not involve human readers for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Abbott AlkP assay on the AEROSET™ System. There is no human-in-the-loop component mentioned; it's an automated quantitative assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence is the performance of the predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer). The new device's results are compared directly to this established method. For precision, the ground truth is often tied to certified reference materials or internal quality control materials with known target values.
The sample size for the training set:
- Not applicable. This is a chemical assay, not an algorithm that requires a "training set" in the machine learning sense. The device is likely calibrated using standardized calibrators, but these are not referred to as a "training set."
How the ground truth for the training set was established:
- Not applicable, as there's no "training set" in the context of this device. Calibrators for such assays are typically prepared using gravimetric or volumetric methods with highly pure chemical substances, and their ground truth concentrations are established through analytical chemistry techniques.

Summary

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K981806

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:

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

Section II Page 2

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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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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:

(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)
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Regulation Number and Section

§ 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.