SPECIALITY URINE 1,2

K971405 · Chiron Diagnostics Corp. · JJY · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971405
• Device Name: SPECIALITY URINE 1,2
• Applicant: Chiron Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Speciality Urine 1,2 is used to monitor miscellaneous specialized urine constituents and bone resorption test procedures.

Device Story

Speciality Urine 1,2 functions as a quality control material for in vitro diagnostic testing. It is used by laboratory personnel to monitor the performance and accuracy of assays measuring specialized urine constituents and bone resorption markers. By providing known values for these analytes, the device allows clinicians to verify the reliability of patient test results, ensuring consistent performance of laboratory test procedures. It is intended for professional use in clinical laboratory environments.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Quality control material for in vitro diagnostic use. Formulated to contain specific urine constituents and bone resorption markers for assay monitoring. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a quality control material to monitor specialized urine constituents and bone resorption test procedures in a clinical laboratory setting.

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

• Beta 2-Micro globulin (Pharmacia)
• Bladder Tumor Antigen (Bard Diagnostic Sciences)
• C-telopeptide (Diagnostic Systems Laboratories, Inc.)
• Creatinine (Ciba Corning Urine 1,2)
• Deoxypyridonoline (DPD) (Chiron ACS 180)
• DPD & PYD (Metra Biosystems, Inc.)
• N-telopeptide (NTX) (Ostex)

Submission Summary (Full Text)

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K971405

CHIRON | DIAGNOSTICS

Chiron Diagnostics Corporation 17392 Daimler Street Irvine, California 92614-5512 714.261.3058 - Fax [phone]

JUN 1 6 1997

## SUMMARY

## 510(k) FOR CHIRON DIAGNOSTICS SPECIALITY URINE 1,2

- 1. Submitter's name, etc.
Chiron Diagnostics Corporation 17392 Daimler St. Irvine, CA 92614

Contact: Dr. Ronald D. Schaefer

Telephone: [phone] FAX: [phone]

April 10, 1997

- Classification Name: CONTROLS MULTIANALYTE CONTROLS, ALL KINDS 2. (ASSAYED AND UNASSAYED)
Common/Usual Name: QUALITY CONTROL MATERIAL

Proprietary Name: Speciality Urine 1,2

- Intended Use: Speciality Urine 1,2 is used to monitor miscellaneous 3. specialized urine constituents and bone resorption test procedures.
- 4. Predicate:
- Beta 2-Micro globulin: Pharmacia 1.
- 2. Bladder Tumor Antigen: Bard Diagnostic Sciences
- 3. C-telopeptide: Diagnostic Systems Laboratories, Inc.
- Creatinine: Ciba Corning Urine 1,2 র্বা
- ട. Deoxypyridonoline (DPD): Chiron ACS 180
- 6. DPD & PYD: Metra Biosystems, Inc.
- 7. N-telopeptide (NTX): Ostex

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUM SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 16 1997

Ronald D. Schaefer, Ph.D. Manager QA/RA Chiron Diagnostics Corporation 17392 Daimler Street Irvine, California 92614-5512

Re : K971405 Speciality Urine 1, 2 Regulatory Class: I Product Code: JJY Dated: April 14, 1997 Received: April 16, 1997

Dear Dr. Schaefer:

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, Druq, 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 Good Manufacturing Practice for Medical Devices :- General-(GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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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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.qov/cdrh/dsmamain.html".

sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number:

Device Name: Speciality Urine 1,2

Indications For Use:

参

Speciality Urine 1,2 is used to monitor miscellaneous specialized urine constituents and bone resorption test procedures.

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

Concurrence of CDRJ, Office of Device Evaluation (ODE)

Prescription Use ﺎ Per 21 CFR §801.109)

OR

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

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