PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS

K040280 · Roche Diagnostics Corp. · JJY · Mar 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040280
• Device Name: PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Precinorm PUC (Proteins in Urine/CSF) is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. The Precipath PUC (Proteins in Urine/CSF) is for the 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 consisting of buffered aqueous solutions with biological additives. They are formulated to represent normal and pathological analyte ranges for urine and CSF protein testing. Used in clinical laboratory settings by technicians or laboratory personnel to verify the performance of quantitative analytical methods. The healthcare provider compares the measured values of the control against the provided value sheet to assess the accuracy and precision of the test system. This monitoring ensures the reliability of patient diagnostic results.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed across seven external laboratories using five independent series per lab, with median values used as setpoints after outlier deletion.

Technological Characteristics

Buffered aqueous solution; liquid, ready-to-use format. Designed for use on Roche Hitachi and Cobas clinical analyzers. Stability: 4 weeks at 2-8 °C once opened.

Indications for Use

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

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

• Roche Diagnostic Precinorm Protein Precipath Protein Controls (K981401)

Submission Summary (Full Text)

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| MAR 1 1 2004 | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>510(k) Summary</b> | |
| <b>Introduction</b> | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| <b>Submitter<br/>name, address,<br/>contact</b> | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 521 - 3831<br><br>Contact Person: Sherri L Coenen<br><br>Date Prepared: February 6, 2004 |
| <b>Device Name</b> | Proprietary name: Precinorm Proteins in Urine/CSF and Precipath Proteins in Urine/CSF Controls<br><br>Common name: Precinorm PUC Precipath PUC<br><br>Classification name: Multi-analyte Controls, All Kinds (assayed and unassayed) |
| <b>Device<br/>Description</b> | The Precinorm PUC and Precipath PUC Controls consist of a buffered aqueous solution with biological materials added as required to obtain desired component levels in either the normal or pathological range. Values for constituent analytes are provided in product labeling. |
| <b>Intended use</b> | 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.<br><br>Precipath 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. |

:

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## 510(k) Summary, Continued

## Substantial Equivalence

The Precinorm PUC and Precipath PUC Controls are substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Precinorm Protein Precipath Protein Controls. (K981401). The intended use of both devices is quality control of their respective test systems.

### Substantial equivalence similarities

The following table compares the Precinorm PUC and Precipath PUC Controls with the predicate device.

and the same of the same of the same of the same of the same of the same of

| Feature | Precinorm PUC<br>Precipath PUC | Precinorm Protein<br>Precipath Protein<br>(Predicate Device) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Precinorm PUC (Proteins in<br>Urine/CSF) is for use in<br>quality control by monitoring<br>accuracy and precision for the<br>quantitative methods as<br>specified in the enclosed value<br>sheet.<br><br>Precipath PUC (Proteins in<br>Urine/CSF) is for use in<br>quality control by monitoring<br>accuracy and precision for the<br>quantitative methods as<br>specified in the enclosed value<br>sheet. | Precinorm Protein and<br>Precipath Protein are used for<br>quality control of the<br>quantitative determination of<br>serum proteins. The controls<br>are used for monitoring<br>accuracy and precision both<br>for manual techniques and for<br>assays on automated clinical<br>chemistry analyzers. |
| Format | Liquid ready-for-use control<br>based on a buffered aqueous<br>solution. Concentrations of<br>control components have been<br>adjusted to represent normal<br>and pathological ranges. | Liquid ready-for-use control<br>based on human serum.<br>Concentrations of control<br>components have been<br>adjusted to represent normal<br>and pathological ranges. |
| Stability | Same | • Unopened: Stable at 2-8°C<br>until expiration date.<br>• Opened: Stable for 4 weeks<br>at 2-8°C. |

ﻳﺎ

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# 510(k) Summary, Continued

Substantial equivalence differences

Comparison of proposed Precinorm PUC and Precipath PUC Controls and predicate device.

| Feature | Precinorm PUC<br>Precipath PUC | Precinorm Protein<br>Precipath Protein<br>(Predicate Device) |
|---------|--------------------------------|--------------------------------------------------------------|
| Matrix | Buffered aqueous solution | Stabilized human serum |

| Constituent Analytes | |
|--------------------------------|----------------------------------------------------------------|
| Precinorm PUC<br>Precipath PUC | Precinorm Proteins<br>Precipath Proteins<br>(Predicate Device) |
| Albumin | α1-acid glycoprotein |
| Creatinine | Albumin |
| Total Protein | α1-antitrypsin |
| Urine/CSF Protein | Antistreptolysin O |
| | C3c |
| | C4 |
| | Ceruloplasmin |
| | C-Reactive Protein |
| | Ferritin |
| | Haptoglobin |
| | IgA |
| | IgG |
| | IgM |
| | Prealbumin |
| | Total Protein |
| | Transferrin |

## Constituent Analytes

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three wavy lines representing the staff and a stylized head representing the snake.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

mar 1 1 2004

Ms Sherri L. Coenen Regulatory Affairs Associate Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k040280

> Trade/Device Name: Precinorm PUC and Precipath PUC Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 6, 2004 Received: February 6, 2004

Dear Ms. Coenen:

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). 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.

Yean 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 Statement

510(k) Number (if known): N/A

Device Name: Precinorm PUC and Precipath PUC Controls

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 PUC (Proteins ir: 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
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Carol C Benson
Division Sign Off

Division Sign-Of

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040280