ELECSYS RBC FOLATE HEMOLYZED REAGENT

K051292 · Roche Diagnostics Corp. · CGN · Jun 17, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051292
• Device Name: ELECSYS RBC FOLATE HEMOLYZED REAGENT
• Applicant: Roche Diagnostics Corp.
• Product Code: CGN · Clinical Chemistry
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate II assay for the quantitative determination of folate in erythrocytes (RBC folate).

Device Story

The Elecsys RBC Folate Hemolyzing Reagent is an ascorbic acid solution used to prepare whole blood samples (heparin or EDTA) for folate measurement. The reagent lyses erythrocytes to liberate and stabilize intracellular folate. The resulting hemolysate serves as a prediluted sample for the Elecsys Folate II assay. The device is used in clinical laboratory settings by trained personnel. The output is a quantitative folate concentration value, which assists healthcare providers in diagnosing and monitoring anemias. The reagent improves stability of the hemolysate compared to previous versions, allowing for a 14-day stability period for the ascorbic acid solution.

Clinical Evidence

Bench testing only. Precision studies were conducted using a modified NCCLS protocol (N=63) on Elecsys 2010 and E170 analyzers. Results showed CVs ranging from 3.6% to 9.5% across various folate concentrations. Expected values were established using clinical cohorts (US N=105; Europe N=282).

Technological Characteristics

Ascorbic acid solution; liquid reagent. Used for erythrocyte lysis and folate stabilization. Compatible with Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. Competitive chemiluminescence test principle.

Indications for Use

Indicated for the quantitative determination of folate in human erythrocytes (RBC folate) to aid in the diagnosis and treatment of anemias. Intended for use on Roche Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay 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 Red Blood Cell Folate Lysing Reagent (K981931)

Submission Summary (Full Text)

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Ko5/292

JUN 1 7 2005

## 510(k) Summary – Elecsys RBC Folate Hemolyzing Reagent

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| 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: May 17, 2005 |
| Device Name | Proprietary name: Elecsys RBC Folate Hemolyzing Reagent |
| | Common name: Folate Assay |
| | Classification name: Acid, Folic, Radioimmunoassay |
| Device<br>description | The Elecsys RBC Folate Hemolyzing Reagent is an ascorbic acid solution<br>with which whole blood treated with anticoagulants (heparin or EDTA) is<br>diluted. After incubation the erythrocytes are lysed and intracellular folate is<br>liberated and stabilized. The hemolysate is then used as a prediluted sample<br>for subsequent measurement in the Elecsys Folate II assay. |
| Intended use | Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys<br>Folate II assay for the quantitative determination of folate in erythrocytes<br>(RBC folate). |
| Predicate<br>Device | We claim substantial equivalence to the Elecsys Red Blood Cell Folate<br>Lysing Reagent currently marketed on the Elecsys 2010 and MODULAR<br>ANALYTICS E170. (K981931). |

:

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## 510(k) Summary – Elecsys RBC Folate Hemolyzing Reagent, continued

Device Comparison The table below illustrates the similarities between the Elecsys Red Blood Cell Folate Lysing Reagent (K981931) and the Elecsys RBC Folate Hemolyzing Reagent (modified device).

| Topic | Elecsys Red Blood Cell Folate<br>Lysing Reagent (K981931) | Elecsys RBC Folate Hemolyzing<br>Reagent (Modified Device) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Red Blood Cell Folate<br>Lysing Reagent to be used in combination<br>with the Elecsys Folate Assay for the<br>quanitation of folate in human red blood<br>cells. | Elecsys RBC Folate Hemolyzing Reagent<br>is used together with the Elecsys Folate II<br>assay for the quantitative determination of<br>folate in erythrocytes (RBC folate). |
| Test Principle | Competitive chemiluminescence | Same |
| Sample Type | Whole blood, heparinized or EDTA | Same |
| Sample / Lysing<br>Reagent Ratio | 1:31 | Same |
| Measuring range | Not provided | Without considering the hematocrit value:<br>up to 1407 nmol/L (620 ng/mL) |
| Pretreatment<br>incubation | 90 minutes ± 15 | Same |
| Stability<br>Ascorbic Acid | 7 days | 14 days |
| Whole blood at -<br>room temp | 4 hours<br>1 day | 2 hours<br>Same |
| Hemolysate at<br>- room temp | not recommended | 3.5 hours |
| Expected Values | N=111, 342 - 786 ng/ml | (US) N=105, 342 - 786 ng/ml<br>(Europe) N=282, 176 - 589 ng/ml |
| Precision | Modified NCCLS (N=60) Whole blood<br>2010 analyzer<br>6.5% CV @ 469 ng/ml<br>4.8% CV @ 850 ng/ml | Modified NCCLS (N=63) Whole blood<br>2010 analyzer<br>6.8% CV @ 478 ng/ml<br>6.6% CV @ 573 ng/ml<br>5.5% CV @ 623 ng/ml<br>E170 analyzer<br>9.5% CV @ 188 ng/ml<br>6.1% CV @ 312 ng/ml<br>3.6% CV @ 410 ng/ml |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

JUN 17 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kay A. Taylor MT(ASCP), RAC Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250

k051292 Re:

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: May 17, 2005 Received: May 18, 2005

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined 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 conninered prior to may 20, 2011 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 Cosmetic (110. (110.) that as nevice, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general voltable provided ing, 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 it may be subject to back dational denal 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 I lease of acrised that I Drimination that your device complies with other requirements of the Act that I Dr Hab Intact and regulations administered by other Federal agencies. You must or any I each 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 CFR Part 807), tacemis 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 me letter will and it your te 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. Benson

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

12051292 510(k) Number (if known):

Device Name: Roche Elecsys Folate II Immunoassay

Indications For Use:

Binding assay for the in vitro quantitative determination of folate in human serum. Dinding assurements obtained by this devices are used in the diagnosis and 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 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)

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Office of In Vitro Diaan Device Evaluation

510(k) k051292

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