ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

K023840 · Bayer Diagnostics Corp. · CKB · Jan 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023840
• Device Name: ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
• Applicant: Bayer Diagnostics Corp.
• Product Code: CKB · Clinical Chemistry
• Decision Date: Jan 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1020
• Device Class: Class 2

Intended Use

The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

Device Story

ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic reagent system for use on the ADVIA 1650 clinical chemistry analyzer. The device measures total and non-prostatic acid phosphatase concentrations in human serum using a colorimetric procedure. Tartrate is used to inhibit prostatic acid phosphatase, allowing for the specific measurement of non-prostatic acid phosphatase; prostatic acid phosphatase levels are derived by calculating the difference between total and non-prostatic measurements. The system is operated by laboratory personnel in a clinical setting. Results are provided to clinicians to assist in the diagnosis and monitoring of various metabolic and malignant conditions, including metastatic prostate cancer and bone-related diseases. The assay provides quantitative data to support clinical decision-making regarding patient disease status.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (11-day, 22-run, 44-replicate protocol) and method comparison against the Roche Hitachi system (N=64 for npACP, N=71 for Total ACP). Correlation coefficients (R) were 0.987 and 0.993 respectively. Minimum Detectable Concentration (MDC) established at 1.98 U/L for total ACP and 2.22 U/L for npACP. Interference testing conducted for bilirubin, hemoglobin, and lipids.

Technological Characteristics

Colorimetric enzymatic assay. Measures total and non-prostatic acid phosphatase via tartrate inhibition. Analytical range: 4 to 200 U/L. Designed for use on the automated ADVIA 1650 clinical chemistry analyzer. Reagents and calibrators are liquid-stable. No specific material standards or software algorithm class specified beyond standard clinical chemistry photometric detection.

Indications for Use

Indicated for the quantitative measurement of total and non-prostatic acid phosphatase in human serum to aid in the diagnosis and monitoring of conditions such as metastatic prostate cancer, Paget's disease, hyperparathyroidism, Gaucher's disease, Niemann-Pick disease, and myelocytic leukemia.

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

• Roche ACP (Reagent 1553437, Calibrator 759350)

Submission Summary (Full Text)

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# JAN 0 7 2003

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Acid Phosphatase method for ADVIA® 1650™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Ka23840

## 1. Intended Use

The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.

### 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|--------------|----------------|-------------------|
| Roche ACP | 1553437 | 759350 |

### 3. Device / Method

| Product Name | Reagent BAN | Calibrator BAN |
|-----------------------------------------|-------------|----------------|
| Bayer ADVIA® 1650TM Acid<br>Phosphatase | B01-4803-01 | B03-4821-01 |

### SUMMARY AND EXPLANATION

Acid phosphatase includes all phosphatases with optimal activity below a pH of 7.0. The greatest concentrations of acid phosphatases are found in human in liver, spleen, milk, erythrocytes, platelets, bone marrow, and prostate gland. Prostatic acid phosphatase is found primarily in the prostate and is tartrate-sensitive. In normal males, prostatic acid phosphatase accounts for about 50% of the serum total acid phosphatase. Enzymatic activity of prostatic acid phosphatase is found elevated in sera of about 60% of men with metastatic prostate cancer. But for carcinomas confined in the prostate gland, the enzyme activity can be normal or only slightly increased. Transient increase in prostatic acid phosphatase can occur after prostate surgery. biopsy, manipulation or catherization, and in the presence of benign prostate hypertrophy, prostatitis and prostate infarction. Serum total acid phosphatase levels, on the other hand, can be elevated in other diseases and conditions such as Paget's disease, hyperparathyroidism with skeletal involvement, cancer metastases to the bone, Gaucher's disease. Niemann-Pick disease and myelocytic leukemia.

The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

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# Imprecision

TOTAL ACP :

| ADVIA 1650 | | |
|----------------|-------------------------|----------------|
| Level<br>(U/L) | Within<br>Run CV<br>(%) | Total<br>CV(%) |
| 18.39 | 3.0 | 9.2 |
| 36.98 | 2.2 | 4.0 |
| 42.23 | 1.9 | 3.8 |

NpACP:

| ADVIA 1650 | | |
|----------------|-------------------------|----------------|
| Level<br>(U/L) | Within<br>Run CV<br>(%) | Total<br>CV(%) |
| 10.01 | 6.2 | 9.2 |
| 24.50 | 3.4 | 4.8 |
| 28.88 | 5.1 | 7.0 |

### Correlation (Y=ADVIA 1650, X=comparison system)

The performance of this method (Y) was compared to the Roche Acid Phosphatase method on the Hitachi system (X). The previously marketed device to which the ADVIA 1650 is compared, uses 1,5 pentanediol. This may be the reason for the observed bias between the two (2) devices.

| Method | Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
|-----------|---------------|-----------------------|----|---------------------|-------------|-------|----------------------|
| NpACP | Serum | Hitachi | 64 | $0.82 x +1.8$ | 2.56 | 0.987 | 6.56 to 98.58 |
| Total ACP | Serum | Hitachi | 71 | $0.76 x +0.91$ | 1.95 | 0.993 | 4.98 to 106.4 |

| | NpACP | ACP |
|-------------------------------------|----------------|---------------|
| 95% confidence level for slope: | 0.787 to 0.856 | 0.7345-0.7781 |
| 95% confidence level for intercept: | 0.793 to 2.811 | 0.189-1.627 |

#### Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | ACP Conc<br>(U/L) | Effect<br>(% change) |
|--------------------------|-----------------------------------|-------------------|----------------------|
| Bilirubin (unconjugated) | 6.25 | 17.19 | -9.3 |
| Bilirubin (conjugated) | 6.25 | 18.42 | -1.7 |
| Hemoglobin | 50 | 11.44 | -8.8 |
| Lipids (Triglycerides) | 1000 | 17.23 | +4.49 |

## Analytical Range

4 to 200 U/L Serum

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#### Minimum Detectable Concentration

Minimum Detectable Concentration (MDC) was determined from the total standard deviation for water obtained from the Precision study – 11 day, 22 runs, and 44 replicates. The concentration equivalent to Mean+2SD for such samples gave the following MDC: total ACP = 1.98 U/L, npACP = 2.22 U/L.

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle head. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 0 7 2003

Mr. Andres Holle Regulatory Affairs Manager Bayer Diagnostics Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k023840

Trade/Device Name: Acid Phosphatase Assay for the ADVIA® 1650™ Regulation Number: 21 CFR 862.1020 Regulation Name: Acid Phosphatase test system Regulatory Class: Class II Product Code: CKB; JIX; JJY Dated: December 23, 2002 Received: December 24, 2002

Dear Mr. Holle:

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, 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 (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 requirements 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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#### Page 2 -

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 [phone]. 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 [phone] or [phone] 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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Page _1_of _1

510(k) Number: ¥っ23840

Device Name: Acid Phosphatase Assay for the ADVIA® 1650™

Indications for Use:

The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| | Division of Clinical Laboratory Devices | | |
| | 510(k) Number_________________________________________________________________________________________________________________________________________________________________ | | |
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| Prescription Use | OR | Over-The-CounterUse | |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |