Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

AI/ML Overview

Acceptance Criteria and Device Performance for ACP (Acid Phosphatase) Assay

Metric	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (ACP Assay)
Total Acid Phosphatase
Correlation Coefficient	Acceptable correlation with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer (implicit)	0.995 (with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer)
Slope	Acceptable (implicit)	1.057
Y-intercept	Acceptable (implicit)	0.417 U/L
Total %CV (Level 1)	Acceptable (implicit)	3.9%
Total %CV (Level 2)	Acceptable (implicit)	2.7%
Linearity	Up to 87.90 U/L (implicit, as the "up to" value for the new device is the acceptance itself)	Up to 87.90 U/L
Limit of Quantitation	0.513 U/L (implicit, as the value for the new device is the acceptance itself)	0.513 U/L
Prostatic Acid Phosphatase
Correlation Coefficient	Acceptable correlation with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer (implicit)	0.989 (with Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer)
Slope	Acceptable (implicit)	1.062
Y-intercept	Acceptable (implicit)	0.651 U/L
Total %CV (Level 1)	Acceptable (implicit)	4.0%
Total %CV (Level 2)	Acceptable (implicit)	4.0%
Linearity	Up to 77.46 U/L (implicit, as the "up to" value for the new device is the acceptance itself)	Up to 77.46 U/L
Limit of Quantitation	0.674 U/L (implicit, as the value for the new device is the acceptance itself)	0.674 U/L

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study demonstrating substantial equivalence to a legally marketed predicate device.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "comparative performance studies" and "precision studies conducted using two levels of control material," but the precise number of patient samples or runs for method comparison is not provided.
- Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission for a clinical chemistry assay in the US, the data would likely be from prospective studies conducted in a laboratory setting for regulatory submission in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of in vitro diagnostic assay typically refers to the results obtained from the predicate device (Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer), which itself is a validated and legally marketed device. Expert human interpretation, as found in imaging or pathology studies, is not the primary method for establishing ground truth in clinical chemistry assays measuring analyte concentrations.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. In this case, the comparison is made between quantitative measurements of two assays.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often with and without AI assistance, which is irrelevant for a quantitative clinical chemistry assay where results are generated by an instrument.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study in the sense that it evaluates the instrument and reagent system (the ACP assay) itself. There isn't a "human-in-the-loop" component in the direct measurement process of a clinical chemistry assay in the same way there might be for an AI-assisted diagnostic tool for image interpretation. The performance characteristics (correlation, precision, linearity, sensitivity) are intrinsic to the assay system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for comparative studies in clinical chemistry is typically established by the legally marketed predicate device's performance results. In this case, the Trace® Acid Phosphatase Assay on the Hitachi® 717 Analyzer served as the comparator or "gold standard" against which the new ACP assay's performance was measured for substantial equivalence.
The sample size for the training set:
- Not applicable. This device is an in vitro diagnostic assay, not an AI/ML algorithm that requires a "training set" to learn from data. The performance characteristics are determined by the chemical reagents and instrument design.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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MAY 1 9 1000

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510(k) Summary

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

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

Date of Preparation of this Summary:	March 25, 1999
Device Trade or Proprietary Name:	ACP
Device Common/Usual Name or Classification Name:	Acid Phosphatase
Classification Number/Class:	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: 49910 / O

Test Description:

Acid Phosphatasc is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

Acid Phosphatase 510(k) March 25, 1999 ACP_5_V3.lwp

Section 11

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Substantial Equivalence:

The Acid Phosphatase assay is substantially equivalent to the Trace® Acid Phosphatase Assay (K880798) on the Hitachi® 717 Analyzer.

These assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of total and . prostatic acid phosphatase.
Both assays yield similar clinical results. .

Differences:

There is a minor difference in the assay range. .

Intended Use:

The Acid Phosphatase assay is used for the quantitation of total and prostatic acid phosphatase in human serum.

Performance Characteristics:

Comparative performance studies for the Total Acid Phosphatase protocol werc conducted using the AEROSET™ System. The Total Acid Phosphatase method comparison yielded acceptable correlation with the Trace Acid Phosphatase assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.995, slope = 1.057, and the Y-intercept = 0.417 U/L. Precision studies were conducted using the Total Acid Phosphatasc protocol. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level I/Panel 101 is 3.9% and Level 2/Panel 102 is 2.7%. Total Acid Phosphatase is linear up to 87.90 U/L. The limit of quantitation (sensitivity) of Total Acid Phosphatasc is 0.513 U/L. These data demonstrate that the performance of Total Acid Phosphatasc is substantially equivalent to the performance of the Trace Acid Phosphatase assay on the Hitachi 717 Analyzer.

Acid Phosphatase 510(k) March 25, 1999 ACP_5_V3.1wp

Section II

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Comparative performance studies for the Prostatic Acid Phosphatase protocol were Conducted using the AEROSET™ System. The Prostatic Acid Phosphatase method comparison yielded acceptable correlation with the Trace Acid Phosphatase assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.989, slope = 1.062, and the the Thison = 0.651 U/L. Precision studies were conducted using the Prostatic Acid Phosphatase protocol. Within-run, between-run, and between-day studies were I respiration i I personal 102 is 4.0% and Level 2/Panel 102 is 4.0%. Prostatic Acid Phosphatase is linear up 1011 10 1211
to 77.46 U/L. The limit of quantitation (sensitivity) of Prostatic Acid Phosphatase is 0.674 U/L. These data demonstrate that the performance of Prostatic Acid Phosphatase is substantially cquivalent to the performance of the Trace Acid Phosphatase assay on the Hitachi 717 Analyzer

Conclusion:

The Acid Phosphatasc assay is substantially equivalent to the Trace Acid Phosphatase assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Acid Phosphatase 510(k) March 25, 1999 ACP 5_V3.lwp

Section II

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 1 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K991010 Trade Name: Acid Phosphatase (ACP) Regulatory Class: II Product Code: CKB Dated: March 25, 1999 Received: March 26, 1999

Dear Ms. Morris:

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 usc 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). 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, listing of devices, good manufacturing practicc, labcling, 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 Regulations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (I DA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Rogister. 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 docs, 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 procced 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/dsma/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): 1991010

Devicc Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

An acid phosphatase (total or prostatic) test system is a device intended to mcasure the activity of the acid phosphatasc enzyme in serum.

(Division Sign-Off)
Division of Clinical Laboratory Device
510(k) Number K991010

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc_ (Pei 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1020 Acid phosphatase (total or prostatic) test system.

(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.