MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY

K043318 · Roche Diagnostics Corp. · CGN · Dec 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043318
• Device Name: MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: CGN · Clinical Chemistry
• Decision Date: Dec 23, 2004
• 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 (Elecsys module) immunoassay analyzers.

Device Story

Modified Class II/III/I device; modifications include increased sample volume, reagent formulation change, value assignment process change, and onboard stability reduction from 6 weeks to 1 week. Device utilizes existing fundamental scientific technology. Design control activities, including risk analysis and verification/validation, performed to ensure performance criteria met. Intended use remains unchanged from previously cleared device.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison of analytical performance characteristics.

Technological Characteristics

In vitro diagnostic device; modifications include reagent formulation, sample volume, and value assignment process. Onboard stability adjusted to 1 week. Fundamental scientific technology remains unchanged.

Indications for Use

Indicated for the in vitro quantitative determination of folate in human serum to aid in the diagnosis and treatment of anemias.

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.

Submission Summary (Full Text)

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DEC 2 3 2004

## 510(k) Summary - Elecsys® Folate II

| 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] |
| | Contact person: Kay A. Taylor |
| | Date prepared: December 1, 2004 |
| Device Name | Proprietary name: Roche Elecsys® Folate II Immunoassay |
| | Common name: Folate Assay |
| | Classification name: Acid, Folic, Radioimmunoassay |
| Device<br>description | The Elecsys Folate II Assay employs a competitive test principle. In the first<br>step, bound folate in the sample is released from endogenous folate binding<br>proteins through incubation with pretreatment reagents. In the second step,<br>ruthenium labeled folate binding protein complexes with the sample. In the<br>third step, after the addition of streptavidin-coated microparticles and folate<br>labeled with biotin, the unbound sites of the ruthenium labeled folate binding<br>protein become occupied, with formation of a ruthenium labeled folate<br>binding protein-folate biotin complex. The complex becomes bound to the<br>solid phase. The reaction mixture is aspirated into the measuring cell where<br>the microparticles are magnetically captured onto the surface of the electrode,<br>unbound substances are removed. Voltage is applied to the electrode<br>inducing chemiluminescent emission which is measured by a photomultiplier.<br>Results are determined using a calibration curve that is generated specifically<br>on each instrument by a 2 point calibration and a master curve provided with<br>the reagent bar code. |

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## 510(k) Summary - Elecsys® Folate II, continued

| 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 (Elecsys module) immunoassay analyzers. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | We claim substantial equivalence to the Elecsys Folate II Immunoassay currently marketed on the MODULAR ANALYTICS E170. (K031756). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate II (K031756) and the Elecsys Folate II (modified device). |

| Topic | Elecsys® Folate II (K031756) | Elecsys® Folate II (Modified Device) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Binding assay for the in vitro<br>quantitative determination of folate in<br>human serum.<br>The binding assay is intended for use<br>on the Roche Elecsys 2010 and<br>MODULAR ANALYTICS E170<br>(Elecsys module) immunoassay<br>analyzers. | Binding assay for the in vitro<br>quantitative determination of folate in<br>human serum.<br>The binding assay is intended for use<br>on the Roche Elecsys 2010 and<br>MODULAR ANALYTICS E170<br>(Elecsys module) immunoassay<br>analyzers. |
| Indications for<br>Use | Measurements obtained by this<br>devices are used in the diagnosis and<br>treatment of anemias of the<br>gastrointestinal malabsorption. | Measurements obtained by this<br>devices are used in the diagnosis and<br>treatment of anemias |
| Test Principle | Competitive chemiluminescence | Same |
| Sample Type | Serum | Same |
| Expected<br>Values | 3.1-17.5 ng/ml | Same |
| Measuring<br>range | 0.600-20.00 ng/ml | Same |

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## 510(k) Summary - Elecsys® Folate II, continued

| Topic | Elecsys® Folate II<br>(K031756) | Elecsys® Folate II<br>(Modified Device) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Traceability | Standardized against Elecsys Folate<br>which was itself standardized against a<br>commercially available radiobinding<br>folate assay | Standardized against Elecsys Folate |
| Stability | Store at 2-8°C unopened up to the<br>expiration date. | Same |
| | Opened: | Opened: |
| | At 2-8°C for 12 weeks | Same |
| | On E170 / 2010 for 6 weeks | On E170 / 2010 for 1 week |

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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 features a stylized eagle with three wavy lines emanating from its head, representing the department's focus on health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 2004

Ms. Kay A. Taylor MT (ASCP), RAC Regulatory Affairs Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Rd. PO Box 50457 Indianapolis, IN 46250-0457

Re: k043318

Trade/Device Name: Roche Elecsys Folate II Immunoassay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: December 1, 2004 Received: December 2, 2004

Dear Ms. Taylor:

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

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my Journe FDA finding of substantial equivalence of your device to a legally premaired 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 Tou may obtain other general 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,

Caul C. Benson for

Cornelia B. Rooks, MA 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): K043318

Device Name: Roche Elecsys Folate II Immunoassay

Indications For Use:

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

The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Prescription Use XX (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 Benam
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safely

510(k) k0413318