ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

K031756 · Roche Diagnostics Corp. · CGN · Jun 25, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031756
• Device Name: ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: CGN · Clinical Chemistry
• Decision Date: Jun 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.

Device Story

Elecsys Folate II Assay is an in vitro diagnostic binding assay for quantitative folate measurement in human serum. It utilizes a competitive chemiluminescent immunoassay principle where folate in the patient sample competes with biotin-labeled folate for binding sites on a ruthenium-labeled folate binding protein (FBP) complex. The assay is performed on Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers. Healthcare providers use the resulting folate concentration levels to assist in the diagnosis and clinical management of anemias associated with gastrointestinal malabsorption. The device provides automated quantitative results to the clinician.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance comparisons and method validation.

Technological Characteristics

Competitive chemiluminescent immunoassay. Reagents include ruthenium-labeled folate binding protein (FBP) and biotin-labeled folate. Designed for use on Roche Elecsys 2010 and Modular Analytics E170 automated immunoassay analyzers. Measuring range: 0.600 - 20.00 ng/ml (1.36 - 45.4 nmol/L).

Indications for Use

Indicated for the in vitro quantitative determination of folate in human serum to aid in the diagnosis and treatment of anemias of gastrointestinal malabsorption. For use on Roche Elecsys 2010 and Modular Analytics E170 analyzers.

Regulatory Classification

Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

Predicate Devices

• Elecsys® Folate Assay (K973674)

Submission Summary (Full Text)

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## JUN 2 5 2003

510(k) Summary - Elecsys® Folate II Assay

| 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 Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Sherri L. Coenen |
| | Date prepared: June 6, 2003 |
| Device Name | Proprietary name: Elecsys® Folate II Assay |
| | Common name: Elecsys® Folate II Assay |
| | Classification name: Vitamin B12 Test System |
| Device<br>description | The Elecsys® Folate II Assay employs a competitive test principle using<br>natural folate binding protein (FBP) specific for folate. Folate in the sample<br>competes with the added folate labeled with biotin for the binding sites on the<br>ruthenium labeled FBP-complex. |
| Intended use | Binding assay for the in vitro quantitative determination of folate in human<br>serum. The binding assay is intended for use on the Roche Elecsys 2010 and<br>Modular Analytics E170 immunoassay analyzers. |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Elecsys® Folate<br>Assay. (K973674). |

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Reagent Summary

The following table describes the similarities and differences between the Elecsys® Folate II Assay and the predicate device.

| Topic | Elecsys® Folate<br>(K973674) | Elecsys® Folate II<br>(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Intended Use | Binding assay for the in vitro<br>quantitative determination of folate in<br>human serum. The binding assay is<br>intended for use on the Roche<br>Elecsys 2010 and Modular Analytics<br>E170 (Elecsys Module) immunoassay<br>analyzers. | Same |
| Method | competitive chemiluminescent<br>immunoassay | Same |
| Sample type | Human Serum | Same |
| Measuring<br>range | 0.600 - 20.00 ng/ml or<br>1.36 - 45.4 nmol/L | Same |
| Expected<br>values | 4.2 - 19.9 ng/ml | 3.1 - 17.5 ng/ml |

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JUN 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

k031756 Re:

> Trade/Device Name: Elecsys® Folate II Assay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: June 3, 2003 Received: June 6, 2003

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. Ilsting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If vour 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,

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

Device Name: Elecsys® Folate II Assay

Indications For Use:

Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

gastomicsema intracted for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |

Alberto Suts

| Division Sign-Off | for Jean Cooper |
|-------------------|-----------------|
|-------------------|-----------------|

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K031756 |
|--------|---------|
|--------|---------|

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