DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K972580 · Bayer Corp. · JMM · Sep 22, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972580
• Device Name: DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: JMM · Clinical Chemistry
• Decision Date: Sep 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1400
• Device Class: Class 1

Intended Use

This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis.

Device Story

The Bayer Immuno 1™ system DPD assay is a heterogeneous competitive immunoassay used to measure deoxypyridinoline in human urine. The device is operated by laboratory personnel in a clinical setting. The assay requires an off-system measurement of urine creatinine, which is manually entered into the system to calculate the DPD/creatinine ratio. This ratio serves as an indicator of bone resorption, assisting clinicians in evaluating bone metabolic status alongside other diagnostic information. The device provides quantitative results to aid in clinical decision-making regarding bone health.

Clinical Evidence

Bench testing only. Performance evaluated via sensitivity (minimum detectable concentration 0.8 nM), imprecision studies (10-day period, 20 runs, 40 assays), and method comparison against the predicate (n=341 samples). Recovery studies showed an average recovery of 101.7% ± 3.8% for spiked samples.

Technological Characteristics

Heterogeneous competitive immunoassay format. Designed for use on the Bayer Immuno 1™ system. Quantitative measurement of DPD in human urine. Requires external input of urine creatinine values.

Indications for Use

Indicated for the quantitative measurement of deoxypyridinoline (DPD) in human urine as an indicator of bone resorption. Results are expressed as a ratio to urine creatinine.

Regulatory Classification

Identification

A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Predicate Devices

• Pyrilinks® -D (Metra Biosystems, Inc.)

Submission Summary (Full Text)

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SEP 22 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:

Gabriel
7/7

Mr. Gabriel J. Muraca, Jr.
Manager, Regulatory Affairs
Bayer Diagnostics
511 Benedict Avenue
Tarrytown, New York 10591-5097

- DEVICE: Deoxypvridinoline Assay for the Bayer Immuno 1™ System
#### PREDICATE DEVICE:

| Name: | Pyrilinks® -D |
|---------------|-------------------------------------------|
| Manufacturer: | Metra Biosystems, Inc. Mountain View, CA |

### INTENDED USE

This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in coniunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis.

### PRINCIPLE OF THE PROCEDURE

The IMMUNO 1 DPD assay is a heterogeneous competitive immunoassay format.

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# PERFORMANCE CHARACTERISTICS

## Sensitivity: Minimum Detectable Concentration

The minimum detectable concentration is 0.8 nM. This is a multisystem estimate of two times the within run standard deviation of the zero calibrator.

## Imprecision

Within run and total imprecision were evaluated for the IMMUNO 1 DPD assay over a 10 day period using two IMMUNO 1 instruments (20 runs total). Three controls were assayed in duplicate for each run making a total of 40 assays. The results are summarized in the following table:

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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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### IMPRECISION of IMMUNO 1 DPD Method

# Method Comparison

A total of 341 human urine samples were assayed by the IMMUNO 1 DPD method and the Pyrilinks® -D method. Urine samples were clarified by centrifugation prior to assay on the IMMUNO 1. The following table lists the correlation results:

### CORRELATION DATA

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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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# Recovery

Eleven urine samples with endogenous DPD levels ranging from 0 nM to 158,5 nM were spiked with 100 nM DPD and the recovered DPD was determined using the IMMUNO 1 DPD method. The recovery results ranged from 96% to 110% with an average of 101.7% ± 3.8%.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right.

SEP 2 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Gabriel J. Muraca, Jr. . Manaqer, Requlatory Affairs Bayer Diaqnostics 511 Benedict Avenue Tarrytown, NY 10591-5097

Re : K972580/S1 Deoxypyridinoline Assay for the Bayer Immuno 1™ System Regulatory Class: II Product Code: JMM, JIS, JJX Dated: September 10, 1997 Received: September 11, 1997

Dear Mr. Muraca

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 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 (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 Regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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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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 requlation (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 Sitman

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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Attachment 7

Page 1 of 1

510(k) Number (if known):

Device Name:

Deoxypyridinoline (DPD)

Indications For Use:

This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmoVL) must be entered from an off-system standard laboratory analysis.

This diagnostic method is not intended for use on any other system.

# EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl Benson for Alfred Montgomery

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K972580 |
|---------------|---------|
|---------------|---------|

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