OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET

K991917 · Metrika, Inc. · JJW · Jul 12, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991917
• Device Name: OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
• Applicant: Metrika, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

Device Story

Osteomark NTx POC Control Set is a human urine-based, liquid, 2-level control set; used in professional clinical settings to verify performance of Osteomark NTx POC test. Controls contain known concentrations of cross-linked N-telopeptides of type I collagen (NTx) and creatinine. Healthcare providers use these samples to monitor analytical precision and detect systematic deviations in device or reagent performance over time. By comparing observed values against expected concentrations, clinicians ensure the reliability of patient test results.

Clinical Evidence

Bench testing only. Three manufactured lots were evaluated for day-to-day performance using a single lot of the Osteomark NTx POC device. Each control level was tested six times daily for five days to demonstrate the ability to evaluate analytical precision and device performance.

Technological Characteristics

Human urine-based matrix with preservatives and food coloring. Quantitative control set. 2-level liquid formulation. Designed for professional use. No software or electronic components.

Indications for Use

Indicated for professional use as a quality control material to verify performance and analytical precision of the Osteomark NTx POC test, which measures cross-linked N-telopeptides of type I collagen normalized to urinary creatinine.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• UrichemTRAK Liquid Assayed Control (K981933)

Submission Summary (Full Text)

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JUL 1:2 1999

# M 三 T R I K A

Metrika Inc 510 Oakmead Parkway Sunnyvale, CA 94086 main 408 524 2255 fax [phone]

### 510(k) SUMMARY

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: | K991917 |
|--------------------------------|---------|
|--------------------------------|---------|

#### 807.92(a)(1) Submitters Information

| Contact Person: | Nancy Mallinak<br>or | Stephen J. Hardt |
|-----------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Address: | Ostex International, Inc.<br>2203 Airport Way South,<br>Suite 400<br>Seattle, WA 98134 | Metrika, Inc.<br>510 Oakmead Parkway<br>Sunnyvale, CA 94086 |
| Phone:<br>Fax: | [phone]<br>[phone] | [phone]<br>[phone] |

Date Summary Prepared: June 4, 1999

| 807.92 (a)(2) Device Information | |
|---------------------------------------------|---------------------------------------------------------------------|
| Trade Name: | Osteomark® NTx Point of Care (POC) Control Set |
| Common Name: | Assayed Urine Controls |
| Classification Name:<br>(Regulation number) | Quality Control Material (Assayed and Unassayed)<br>21 CFR 862.1660 |

| 807.92 (a)(3) Predicate Device Information | | | |
|--------------------------------------------|------------------------------------|--|--|
| Name: | UrichemTRAK Liquid Assayed Control | | |
| Manufacturer: | Medical Analysis System Inc | | |

### 807.92 (a)(4) Device Description

The Osteomark® NTx Point of Care Control Set is a human urine-based, liquid, 2-level control set to be used in quality control procedures with the Osteomark® NTx Point of Care test. The assayed control set is used for evaluating precision and systematic analytical deviations that may arise from reagent or device variations.

|||

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# 807.92 (a)(5) Statement of Intended Use

The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

### 807.92 (a)(6) Summary of Technological Characteristics

| CHARACTERISTIC | Osteomark® NTx Point of Care Control Set | UrichemTRAK Liquid Assayed Control K981933 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance. | UrichemTRAK Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK Control with patient urine specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. |
| Matrix | Human urine-based materials, preservative, and food coloring | Human urine-based material and preservative |
| Testing Environment | professional use | professional use |

# Similarities Between Osteomark® NTx Point of Care Control Set and UrichemTRAK Liquid Assayed Control

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### 807.92 (a)(6) Summary of Technological Characteristics (continued)

| CHARACTERISTIC | Osteomark® NTx Point of Care<br>Control Set | UrichemTRAK Liquid Assayed<br>Control<br>K981933 |
|----------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte(s) | cross-linked N-telopeptides of type 1<br>collagen and creatinine | (Various urinary constituents)<br>Amylase<br>Calcium<br>Glucose<br>Magnesium<br>Total protein<br>Uric acid<br>Phosphorus<br>Urea Nitrogen<br>Creatinine<br>Chloride<br>Potassium<br>Sodium<br>Microalbumin |
| Test Method | quantitative | quantitative and qualitative |

# Differences Between Osteomark® NTx Point of Care Control Set and UrichemTRAK Liquid Assayed Control

The differences in the two assayed control materials do not raise new issues of safety and effectiveness.

# 807.92 (b)(1) to b(3) Performance Data and Conclusion

Three manufactured lots of the Osteomark® NTx POC Control Set were evaluated to assess day to day performance with a single lot of Osteomark® NTx POC device. Each control level per control lot was tested six times a day for five days. The data demonstrated that Osteomark® NTx POC Control Set will evaluate the quality of day to day performance of the Osteomark® NTx POC device. Therefore, Osteomark® NTx POC Control is substantially equivalent to existing products in commercial distribution such as the UrichemTRAK Liquid Assayed Control system.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is slightly tilted.

JUL 1:2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen J. Hardt Metrika, Inc. 510 Oakmead Parkway Sunnyvale, California 94086

K991917 Re:

Trade Name: Osteomark® NTx Point of Care (POC) Control Set Regulatory Class: I Product Code: JJW Dated: June 4, 1999 Received: June 7, 1999

Dear Mr. Hardt:

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 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 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 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 (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 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 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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June 4, 1999 Premarket Notification

"

510(k) Number: K 991917

Device Name: Osteomark® NTx Point of Care Control Set

### INDICATIONS FOR USE

The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division Sign-Off**
Division of Clinical Laboratory Devices K991917
510(k) Number

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use (Optional Format 1-2-96)