MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)

K041812 · Roche Diagnostics Corp. · JJY · Jul 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041812
• Device Name: MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Precinorm ® PUC/ Precipath ® PUC is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet

Device Story

Precinorm® PUC and Precipath® PUC are liquid, ready-to-use quality control materials based on buffered aqueous solutions. They are used in clinical laboratory settings to monitor the accuracy and precision of quantitative analytical methods on Roche/Hitachi MODULAR and COBAS INTEGRA analyzer systems. The modification involved adding Immunoglobulin A (IgA) and Immunoglobulin M (IgM) constituents to the Precipath® PUC formulation and updating the associated value sheets. The device functions as a control sample; healthcare providers compare analyzer results against assigned values to verify system performance and ensure reliable clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid, ready-to-use control based on buffered aqueous solution. Analyte concentrations adjusted for normal and pathological ranges. Stability: Unopened at 2-8 °C until expiration; opened at 2-8 °C for 4 weeks. Multi-analyte control (Class I, 21 CFR 862.1660).

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and precision of quantitative laboratory methods for proteins in urine and cerebrospinal fluid (CSF).

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

• Precinorm® Universal and Precipath® Universal Control Sera (K040280)

Submission Summary (Full Text)

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K041812

JUL 2 7 2004

## 510(k) Summary - Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® Proteins in Urine/CSF (PUC)

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Theresa M. Ambrose |
| | Date prepared: July 2, 2004 |
| Device Name | Proprietary name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ®<br>Proteins in Urine/CSF (PUC) |
| | Common name: Precinorm ® PUC/ Precipath ® PUC |
| | Classification name: Multi-analyte controls, all kinds (assayed and<br>unassayed) |
| Device<br>description | Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control based<br>on a buffered aqueous solution. Concentrations of control components have<br>been adjusted to represent normal and pathological ranges. |
| Intended use | Precinorm ® PUC/ Precipath ® PUC is for use in quality control by<br>monitoring accuracy and precision for the quantitative methods as specified in<br>the enclosed value sheet |
| | Continued on next page |

23

ﮨﮯ

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## 510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued

| Substantial<br>Equivalence | Roche claims substantial equivalence to the currently marketed Roche<br>Diagnostics Precinorm® Universal and Precipath® Universal Control Sera<br>(K040280). |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence –<br>Device<br>comparison | The table below compares Precinorm® PUC / Precipath® PUC with the<br>predicate device (currently marketed Precinorm® PUC / Precipath® PUC). |

| Characteristic | Precinorm U/ Precipath U<br>(Predicate device, K040280) | Precinorm U/ Precipath U<br>(Modified Device) |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in quality control by<br>monitoring accuracy and precision<br>for the quantitative methods as<br>specified in the enclosed value sheet | Same |
| Format | Liquid ready-for-use control based<br>on a buffered aqueous solution.<br>Concentrations of control<br>components have been adjusted to<br>represent normal and pathological<br>ranges. | Same |
| Stability | Unopened<br>Stable at 2-8°C until expiration date<br>Opened:<br>Stable at 2 to 8°C for 4 weeks | Same |
| Constituent Analytes<br>with Assigned Values | Precinorm<br>• Albumin<br>• Creatinine<br>• Total Protein<br><br>Precipath<br>• Albumin<br>• Creatinine<br>• Total Protein | Precinorm<br>Same<br><br>Precipath<br>• Albumin<br>• Creatinine<br>• Total Protein<br>• Immunoglobulin A<br>• Immunoglobulin M |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Theresa M. Ambrose, PhD RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

k041812 Re:

Trade/Device Name: Precinorm® Proteins in Urine/ CSF (PUC) Precipath ® Proteins in Urine/ CSF (PUC) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 2, 2004 Received: July 6, 2004

Dear Dr.. Ambrose:

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).

JUL 27 2004

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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). You may obtain other general information on your responsibilities under the Act 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,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Ko41812

Device Name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® Proteins in Urine/CSF (PUC)

Indications For Use:

Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® and proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberts
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

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