ELECSYS PRECICONTROL MULTIANALYTE

K033937 · Roche Diagnostics Corp. · JJY · Jan 7, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033937
• Device Name: ELECSYS PRECICONTROL MULTIANALYTE
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.

Device Story

Elecsys PreciControl MultiAnalyte is a quality control product for Elecsys C-Peptide and Insulin immunoassay systems. It consists of lyophilized synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. Used in clinical laboratory settings to monitor assay performance. Healthcare providers reconstitute the product with distilled water and run it on Elecsys immunoassay analyzers to verify system accuracy and precision. Results help ensure reliability of patient test measurements.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material; analytical performance characteristics such as precision, linearity, and method comparison are not applicable to the control product itself.

Technological Characteristics

Lyophilized multi-analyte control; matrix: buffered equine serum; analytes: synthetic human C-Peptide and recombinant human insulin; format: two levels; reconstitution: 2.0mL distilled water; storage: 2-8°C (unopened), -20°C (reconstituted).

Indications for Use

Indicated for quality control of Elecsys C-Peptide and Elecsys Insulin 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 Cardiac (K032089)

Submission Summary (Full Text)

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JAN - 7 2004

| JAN - 7 2004 | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary <span style="float:right;">K033937</span> | |
| 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 Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723<br><br>Contact Person: Theresa M. Ambrose<br><br>Date Prepared: December 18, 2003 |
| Device Name | Proprietary name: Elecsys® PreciControl MultiAnalyte<br>Common name: PreciControl MultiAnalyte<br>Classification name: Multi-analyte Controls (assayed and unassayed) |
| Predicate device | The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the currently marketed Elecsys® PreciControl Cardiac (K032089). |
| Device Description | The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems. |
| Continued on next page | |

:

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# 510(k) Summary, Continued

The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the Comparison to predicate currently marketed Elecsys® PreciControl Cardiac (K032089).The below device tables compare Elecsys® PreciControl MultiAnalyte with the predicate device, Elecsys® PreciControl Cardiac (K032089).

## Similarities

. 7

| Characteristic | Elecsys®<br>PreciControl<br>MultiAnalyte | Predicate device<br>Elecsys® PreciControl<br>Cardiac |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl<br>MultiAnalyte is used<br>for quality control of<br>the Elecsys C-Peptide<br>and Elecsys Insulin<br>immunoassays on the<br>Elecsys immunoassay<br>systems. | PreciControl Cardiac is<br>used for quality control<br>of the Elecsys CK-MB,<br>Digoxin, Myoglobin,<br>and NT-proBNP<br>immunoassays on the<br>Elecsys immunoassay<br>systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with<br>exactly 2.0 mL distilled<br>water and allow to<br>stand closed for 15<br>minutes. | Same |

Continued on next page

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#### 510(k) Summary, Continued

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Differences

្រុះ

| Characteristic | Elecsys®<br>PreciControl<br>MultiAnalyte | Predicate device<br>Elecsys® PreciControl<br>Cardiac |
|----------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Equine serum with<br>added C-Peptide and<br>insulin | Human serum with<br>added CK-MB,<br>digoxin, myoglobin,<br>and NT-proBNP |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• At -20°C : 1 months<br>• On the analyzers : 3 hrs | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• At 2-8°C : 3 days<br>• At -20°C : 3 months<br>• On the analyzers : 3 hrs |

## Performance Characteristics

The Elecsys® PreciControl MultiAnalyte was evaluated for value assignment and 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 depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 7 2004

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

k033937 Re:

Trade/Device Name: Elecsys® PreciControl MultiAnalyte Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 18, 2003 Received: December 19, 2003

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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prices 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). and Oosmeter for ( ro ) re re re, subject to the general controls provisions of the Act. The r ou may, atteres 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 your de roo subject to such additional controls. Existing major regulations affecting your device it may be subject to back and Federal Regulations (CFR), Parts 800 to 895. In addition, I'DA 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 or any I 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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 K 0339 37

Device Name: Elecsys® PreciControl MultiAnalyte

Indications For Use:

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.

Prescription Use (Per 21 CFR 801 409)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Carl Bensen
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_E033937