MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA

K041227 · Roche Diagnostics Corp. · JJY · May 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041227
• Device Name: MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Precinorm ® U/ Precipath ® U 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 Universal and Precipath Universal are assayed quality control sera; used in clinical laboratories to monitor precision of testing procedures. Modification involves addition of bovine plasma albumin to existing human serum protein base. Device functions as reference material for laboratory quality assurance; provides expected values for specific analytes to verify assay performance. Used by laboratory technicians/pathologists to ensure analytical accuracy and consistency of clinical chemistry testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human sera; two-level control product. Analyte source for albumin/total protein in Precinorm U includes human serum and bovine plasma albumin. Stable at 2-8°C until expiration; reconstituted stability varies by temperature (5 days at 2-8°C, 12 hours at 15-25°C, 1 month at -15 to -25°C).

Indications for Use

Indicated for use as assayed quality control sera to monitor precision of laboratory testing procedures for clinical chemistry analytes in human serum samples.

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 (K992900)

Submission Summary (Full Text)

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MAY 27 2004

K041227

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

| 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]<br><br>Contact person: Theresa M. Ambrose<br><br>Date prepared: May 7, 2004 |
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal and Precipath ®<br>Universal Control Sera<br><br>Common name: Precinorm U / Precipath U<br><br>Classification name: Multi-analyte controls, all kinds (assayed and<br>unassayed) |
| Device<br>description | Precinorm ® U/ Precipath ® U is a two level quality control product<br>consisting of lyophilized human sera with constituents added as required to<br>obtain desired component levels |
| Intended use | Precinorm ® U/ Precipath ® U is for use in quality control by monitoring<br>accuracy and precision for the quantitative methods as specified in the<br>enclosed value sheet |
| | Continued on next page |

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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>(K992900). |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence -<br>Device<br>comparison | The table below compares Precinorm U/ Precipath U with the predicate<br>device (currently marketed Precinorm U/ Precipath U). |

| Characteristic | Precinorm U/ Precipath U<br>(Predicate device, K992900) | 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 | Lyophilized human sera with<br>constituents added as required to<br>obtain desired component levels | Same |
| Analyte source for<br>albumin and total<br>protein methods in<br>Precinorm U | Human serum | Human serum and bovine<br>plasma albumin |
| Analyte source for<br>albumin and total<br>protein methods in<br>Precipath U | Human serum | Same |
| Levels | Two levels | Same |
| Stability | Lyophilized<br>Stable at 2-8°C until expiration date<br>Reconstituted:<br>· 2 to 8°C : 5 days<br>· 15 to 25 °C : 12 hours<br>· -15 to -25°C: 1 month (when<br>frozen once)<br>Exceptions for total and direct<br>bilirubin as noted in package insert. | Same |

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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 lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 7 2004

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

k041227 Re:

Trade/Device Name: Precinorm ® Universal and Precipath ® Universal Control Sera Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assay and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 7, 2004 Received: May 10, 2004

Dear Dr. Ambrosc:

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 docs 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter with and in your finding of substantial equivalence of your device to a legally promation hotel noticated 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 you destions 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 Four may 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):

K041227

Precinorm ® Universal and Precipath ® Universal Control Sera Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Precinorm U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath U is for use in quality quantitative methods as specificul in the cholorous value in 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)

Carol C. Benson

vision Sign-Off

fice of In Vitro Diagnostic Device valuation and Safety

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510(k) K041227

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