ELECSYS PRECICONTROL ANEMIA

K051517 · Roche Diagnostics Corp. · JJY · Jul 5, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051517
• Device Name: ELECSYS PRECICONTROL ANEMIA
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.

Device Story

Elecsys® PreciControl Anemia is a lyophilized quality control product; consists of human serum matrix spiked with Ferritin and Aprotinine. Used in clinical laboratory settings to monitor performance of Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays. Product requires reconstitution with distilled water before use. Healthcare professionals use the control to verify assay accuracy and precision on Elecsys® immunoassay systems; results help ensure reliability of patient diagnostic testing for anemia-related markers.

Clinical Evidence

No clinical data. Performance evaluated via bench testing for value assignment and stability characteristics.

Technological Characteristics

Lyophilized human serum matrix containing ferritin (human origin) and aprotinine (bovine origin). Three levels of control. Reconstituted with distilled water. Stability verified for various storage conditions (refrigerated, frozen, and on-analyzer).

Indications for Use

Indicated for quality control of Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on Elecsys® immunoassay systems.

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

• Elecsys® PreciControl MultiAnalyte (k033937)

Submission Summary (Full Text)

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| JUL | 5 - 2005 |
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and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the

K 05/5/17

# 510(k) Summary

| Introduction | 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. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723<br><br>Contact Person: Corina Harper<br><br>Date Prepared: Jun 6, 2005 |
| Device Name | Proprietary name: Elecsys® PreciControl Anemia<br><br>Common name: PreciControl Anemia<br><br>Classification name: The FDA has classified Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I. |
| Predicate device | The Elecsys® PreciControl Anemia is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems. |
| | Continued on next page |

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## 510(k) Summary, Continued

| | Comparison to The Elecsys® PreciControl Anemia is substantially equivalent to the |
|------------------|----------------------------------------------------------------------------------------------------------------------------|
| predicate device | currently marketed Elecsys® PreciControl MultiAnalyte (K033937). The |
| | below tables compare Elecsys® PreciControl Anemia with the predicate device, Elecsys® PreciControl MultiAnalyte (K033937). |

#### Similarities

| Characteristic | Elecsys® PreciControl<br>Anemia | Predicate Device<br>Elecsys® PreciControl<br>MultiAnalyte<br>(K033937) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® PreciControl<br>Anemia is used for quality<br>control of the Elecsys®<br>Ferritin, Folate II, and<br>Vitamin B12 immunoassays<br>on the Elecsys®<br>immunoassay systems. | Elecsys® PreciControl<br>MultiAnalyte is used for<br>quality control of the Elecsys®<br>C-Peptide and Elecsys Insulin<br>immunoassays on the<br>Elecsys® immunoassay<br>systems. |
| Levels | Three | Two |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 2.0<br>mL of distilled water and<br>allow to stand closed for 30<br>minutes to reconstitute, and<br>then mix gently. | Reconstitute with exactly 2.0<br>mL of distilled water and allow<br>to stand closed for 15 minutes<br>to reconstitute, and then mix<br>gently. |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20 - 25 °C: up to 8 hrs<br>• on the analyzers at 20-<br>25°C: up to 5 hrs<br>• at 2-8°C: 3 days<br>• at -20°C: 1 month (freeze<br>only once)<br>• after thawing: use only<br>once | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• on the analyzers at 20-25°C:<br>up to 3 hrs<br>• at -20°C: 1 month (freeze<br>only once)<br>• after thawing: use only once |

Continued on next page

Roche Diagnostics Confidential

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### 510(k) Summary, Continued

| Characteristic | Elecsys® PreciControl<br>Anemia | Predicate Device<br>Elecsys® PreciControl<br>MultiAnalyte<br>(K033937) |
|----------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Matrix | Human serum with added<br>Ferritin (human origin) and<br>Aprotinine (bovine origin) | Equine serum with added<br>C-Peptide and insulin |

The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Ms. Corina Harper, RAC Regulatory Affairs Consultant Centralized Diagnostics Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416

JUL 5 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k051517

> Trade/Device Name: Elecsys® PreciControl Anemia Regulation Number: 21 CFR 862.1660 Regulation Name: Multi-Analyte controls all kinds (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 6, 2005 Received: June 8, 2005

Dear Ms. Harper:

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 vour 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) 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/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): K051517

Device Name:

Elecsys® PreciControl Anemia

Indications For Use:

Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

K
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number

Roche Diagnostics Confidential

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