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

The provided text describes specific performance characteristics of the AlkP (Alkaline Phosphatase) assay, focusing on its substantial equivalence to a previously cleared device. Here's a breakdown of the acceptance criteria and study details based on the input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Method Comparison (AEROSET vs. Hitachi 717)	Acceptable correlation with Roche Alkaline Phosphatase assay on Hitachi 717	Pooled data: Correlation coefficient = 0.999, Slope = 1.06, Y-intercept = -0.12 U/L
Method Comparison (ARCHITECT c8000 vs. AEROSET)	Acceptable correlation with AEROSET System	ARCHITECT c8000 Systems (3): Correlation coefficients = 1.000, 1.000, 1.000; Slopes = 0.99, 0.99, 0.98; Y-intercepts = -2.89, -1.67, 1.21 U/L respectively
Precision (Original vs. Modified Parameters)	Equivalent precision performance between original and modified parameters (p-values > 0.05 from F-test)	F-test yielding p-values > 0.05, demonstrating equivalent precision
Precision (AEROSET - 20 day studies)	Not explicitly stated, but established by equivalent performance to original, previously cleared assay.	Level 1 Total %CV: 3.2%; Level II Total %CV: 2.5%
Precision (ARCHITECT c8000 - 20 day studies)	Not explicitly stated, but established by equivalent performance to original, previously cleared assay.	Level I Total %CV: 4.1% to 5.7%; Level II Total %CV: 1.9% to 2.2%
Linearity	Not explicitly stated, but assumed to be within clinically acceptable ranges.	Linear up to 4,555 U/L
Limit of Quantitation (Sensitivity)	Not explicitly stated, but assumed to meet clinical needs.	4.6 U/L

2. Sample size used for the test set and the data provenance

Sample Size:
- For the AEROSET system method comparison with Hitachi 717: 40 samples were run on each of the three AEROSET systems, for a total of 120 samples.
- For the ARCHITECT c8000 system method comparison with AEROSET system: The number of samples is not explicitly stated in the provided text, only that three ARCHITECT c8000 Systems were used. (It's possible it was also 40 samples per system, but not specified).
- For 20-day precision studies: The number of samples for each level of control material is not specified, only that "two levels of control material" were used.
- For 5-day precision studies: The number of samples for each control material level with original and modified parameters is not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study seems to be conducted by the manufacturer, Abbott Laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study involves an in vitro diagnostic assay for quantitative determination of a biomarker (alkaline phosphatase). The "ground truth" or reference is established by established, cleared predicate devices (Roche Alkaline Phosphatase assay on Hitachi 717 Analyzer and the AEROSET System itself), not by human expert consensus or interpretation of images.

4. Adjudication method for the test set

Not applicable. As noted above, this study does not involve human interpretation or subjective assessment that would require an adjudication method. The comparisons are quantitative measurements against predicate devices.

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 device study, not an AI-assisted diagnostic imaging or human-in-the-loop study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are standalone performance evaluations of the modified AlkP assay. The results (correlation, slope, intercept, precision, linearity, limit of quantitation) directly reflect the analytical performance of the device itself.

7. The type of ground truth used

The "ground truth" in this context is the quantitative measurement obtained from legally marketed predicate devices. Specifically:

For the AEROSET system, the predicate was the Roche Alkaline Phosphatase assay on the Hitachi 717 Analyzer.
For the ARCHITECT c8000 System, the predicate was the AEROSET System (which itself was compared to the Hitachi 717).

8. The sample size for the training set

Not applicable. This is a traditional in vitro diagnostic assay with modifications to existing parameters, not a machine learning model that requires a "training set" in the conventional sense. The "training" here would be the development and optimization process by R&D engineers, not a data-driven model training.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The development and optimization of such assays typically rely on extensive chemical and biological experimentation, calibration using reference materials, and iterative improvements to assay formulation and parameters, rather than a labeled training dataset.

Summary

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Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving. Texas 75038

Contact Person Linda Morris Sr. Regulatory Specialist MS 1-8 ADD Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	November 12, 2002
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: Hoa3g 07 .

Test Description:

Substantial Equivalence:

The modified Alkaline Phosphatase assay is substantially equivalent to the cleared Alkaline Phosphatase assay (K981806) on the AEROSET® System for the serum or plasma applications. The modifications included changes in the assay parameters for sample volume, main read time, absorbance limit and calibration factor. These modifications did not significantly change the safety and effectiveness profile of the device as demonstrated in the Performance Characteristics Summary.

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significantly change the safety and effectiveness profile of the device as demonstrated in the Performance Characteristics Summary.

Intended Use:

The modified 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 and the ARCHITECT®c8000™ System. For the AEROSET System, the modified Alkaline Phosphatase assay method comparison yielded acceptable correlation with the Roche Alkaline Phosphatase assay on the Hitachi 717 Analyzer. Three (3) AEROSET systems were used for the comparative studies with the Hitachi system. Forty samples were run on each of the three AEROSET systems. The correlation coefficient of the pooled data = 0.999, slope = 1.06, and Y-intercept = -0.12 U/L. For the ARCHITECT c8000 System. the modified Alkaline Phosphatase assay method comparison vielded acceptable correlation with the AEROSET System. Three (3) ARCHITECT c8000 Systems were used for the comparative performance studies with the AEROSET system. The correlation coefficients were =1.000. 1.000, 1.000, slopes = 0.99, 0.99, 0.98, and Y-intercepts = -2.89, -1.67, 1.21 U/L respectively. Twenty (20) day precision studies were conducted using

the original Alkaline Phosphatase assay parameters on the AEROSET and

ARCHITECT c8000 systems. Five (5) day precision studies using the original and modified parameters were conducted on the AEROSET and ARCHITECT c8000 systems to determine the impact of the change in parameters on the assay precision performance. A statistical analysis was performed to compare the results obtained from the original parameters to the results obtained with the modified parameters. This analysis demonstrated equivalent precision performance between the original and modified parameters on both systems, with the F-test yielding p-values greater than 0.05. The parameter changes did not impact the precision performance, therefore results from the 20 day studies will be used for the AEROSETand ARCHITECT c8000 claims. Within-run, between-run, and between-day studies were performed using two levels of control material. On the AEROSET, the total

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%CV for Level 1 is 3.2% and Level II is 2.5%. On the ARCHITECT c8000 System, the total %CV for Level I ranged from 4.1% to 5.7%, and for Level II the total %CV ranged from 1.9% to 2.2%. The modified Alkaline Phosphatase assay is linear up to 4,555 U/L. The limit of quantitation (sensitivity) of the modified Alkaline Phosphatase assay is 4.6 U/L. These data demonstrate that the performance of the modified Alkaline Phosphatase assay is substantially equivalent to the performance of the cleared Alkaline Phosphatase.

Conclusion:

The modified Alkaline Phosphatase assay is substantially equivalent to the Alkaline Phosphatase (K981806) assay as demonstrated by results obtained in the studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

ockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist Abbott Diagnostics Manufacturing, Inc ADD Regulatory Affairs 1920 Hurd Drive Irving, TX 75038

DEC 26 2002

K023807 Re:

Trade/Device Name: Alkaline Phosphatase Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: November 12, 2002 Received: November 14, 2002

Dear Ms. Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other reguirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko 23 807 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.

tan Conyer

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.