ALKP

K981806 · Abbott Laboratories · CJE · Jun 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981806
• Device Name: ALKP
• Applicant: Abbott Laboratories
• Product Code: CJE · Clinical Chemistry
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma.

Device Story

In vitro diagnostic assay for quantitative determination of alkaline phosphatase in human serum or plasma; utilizes p-nitrophenyl phosphate (p-NPP) substrate; alkaline phosphatase catalyzes hydrolysis of p-NPP to p-nitrophenol and inorganic phosphate; rate of absorbance increase at 404 nm measured; zinc and magnesium ions used as activators; performed on AEROSET System; results used by clinicians to diagnose and monitor liver, bone, parathyroid, and intestinal diseases.

Clinical Evidence

Bench testing only. Method comparison study against predicate (Hitachi 717 Analyzer) yielded correlation coefficient of 0.9992, slope 1.031, and Y-intercept 1.397 U/L. Precision studies (within-run, between-run, between-day) showed total %CV of 3.2% (Level 1) and 2.5% (Level 2). Assay linear up to 8,254.6 U/L; limit of quantitation 5.7 U/L.

Technological Characteristics

In vitro diagnostic chemical assay; utilizes p-nitrophenyl phosphate substrate; zinc and magnesium ion activators; photometric detection at 404 nm; designed for use on automated clinical chemistry analyzers (AEROSET System).

Indications for Use

Indicated for the measurement of alkaline phosphatase in human serum or plasma to aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Regulatory Classification

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.

Predicate Devices

• Boehringer Mannheim Alkaline Phosphatase/AMP assay (K823213)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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:

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.

### 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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Page 2

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 [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 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 [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/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:

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.

(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<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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