ACP

K991010 · Abbott Diagnostics Mfg., Inc. · CKB · May 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991010
• Device Name: ACP
• Applicant: Abbott Diagnostics Mfg., Inc.
• Product Code: CKB · Clinical Chemistry
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1020
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic assay for quantitative determination of total and prostatic acid phosphatase in human serum; utilizes clinical chemistry method where acid phosphatase catalyzes hydrolysis of alpha-naphthylphosphate; alpha-naphthol couples with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form diazo dye; absorbance measured at 412 and 660 nm; L-Tartrate used to inhibit prostatic acid phosphatase to differentiate total vs. non-prostatic levels; used on AEROSET System; results used by clinicians to assess enzyme activity; aids in clinical decision-making regarding patient disease state.

Clinical Evidence

Bench testing only. Method comparison studies on AEROSET System vs. Trace Acid Phosphatase assay on Hitachi 717. Total Acid Phosphatase: r=0.995, slope=1.057, intercept=0.417 U/L. Prostatic Acid Phosphatase: r=0.989, slope=1.062. Precision: Total Acid Phosphatase CV 2.7-3.9%; Prostatic Acid Phosphatase CV 4.0%. Linearity up to 87.90 U/L (Total) and 77.46 U/L (Prostatic). Sensitivity (LOQ) 0.513 U/L (Total) and 0.674 U/L (Prostatic).

Technological Characteristics

In vitro clinical chemistry assay; photometric detection (412/660 nm); enzymatic hydrolysis principle; L-Tartrate inhibition for isoenzyme differentiation; liquid reagent system for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of total and prostatic acid phosphatase in human serum for clinical diagnostic purposes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Trace Acid Phosphatase Assay (K880798)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)