CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY

K981931 · Roche Diagnostics/Boehringer Mannheim GmbH · CGN · Aug 25, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981931
• Device Name: CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY
• Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
• Product Code: CGN · Clinical Chemistry
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Device Story

Elecsys® Red Blood Cell Folate Lysing Reagent facilitates folate measurement in human red blood cells; used in conjunction with Elecsys® Folate Assay. Process involves reconstituting ascorbic acid packet in water; incubating 15 μl sample with pretreatment reagents (15 μl and 10 μl) to liberate bound folate into serum. Subsequent analysis performed on Boehringer Mannheim Elecsys 2010 immunoassay analyzer using electrochemiluminescence (ECLIA) competitive assay principle. Total assay duration approximately 90 minutes. Intended for clinical laboratory use to assist in folate status assessment.

Clinical Evidence

Bench testing only. Studies included evaluation of assay precision per NCCLS recommendations, demonstration of linearity, correlation with the predicate device, and sample type studies.

Technological Characteristics

Reagent kit for sample pretreatment; utilizes electrochemiluminescence (ECLIA) competitive assay principle on the Elecsys 2010 immunoassay analyzer. Includes ascorbic acid for reconstitution and pretreatment reagents for folate liberation. No specific material standards or software architecture details provided.

Indications for Use

Indicated for the quantitation of folate in human red blood cells when used in combination with the Elecsys® Folate Assay on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

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

• Bio-Rad Quantaphase II® FOLATE Radiobinding assay (K935286)

Reference Devices

• Elecsys® Folate Assay (K973674)

Submission Summary (Full Text)

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## 510(k) Summary

| 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. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics/Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94566-0900<br>[phone]<br><br>Contact Person: Patricia M. Klimley<br>Date Prepared: June 1, 1998 |
| 2) Device name | Proprietary name: Elecsys® Red Blood Cell Folate Lysing Reagent<br><br>Common name: Elecsys® Red Blood Cell Folate Lysing Reagent is to be used<br>in combination with the Elecsys® Folate Assay for the quantitation of folate in<br>human red blood cells.<br><br>Classification name: Folate Test System. |
| 3) Predicate<br>device | We claim substantial equivalence to the Bio-Rad Quantaphase II® FOLATE<br>Radiobinding assay (K935286). |
| 4) Device<br>Description | The Elecsys® test principle is based on the competitive principle. Total<br>duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions. |
| 5) Intended use | The Elecsys Red Blood Cell Folate Lysing Reagent is to be used in<br>combination with the Elecsys Folate Assay for the quantitation of folate in<br>human red blood cells.<br>The electrochemiluminescence assay "ECLIA" is intended for use on the<br>Boehringer Mannheim Elecsys 2010 immunoassay analyzer. |
| 6) Comparison<br>to predicate<br>device | The Roche Diagnostics/Boehringer Mannheim Elecsys Red Blood Cell Folate<br>is substantially equivalent to other products in commercial distribution<br>intended for similar use. Most notably it is substantially equivalent to the<br>currently marketed Bio-Rad Quantaphase II® Folate Radiobinding assay . |
| | Elecsys studies performed include:<br>• evaluation of assay precision according to NCCLS recommendations<br>• demonstration of linearity<br>• correlation with the predicate device<br>• sample type studies |

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## 510(k) Summary, Continued

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 25 1998

Patricia M. Klimley Regulatory Affairs Manager Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

Re: K981931 Elecsys® Red Blood Cell Folate Lysing Reagent Requlatory Class: II Product Code: CGN Dated: June 1, 1998 Received: June 2, 1998

Dear Ms. Klimley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Elecsys® Red Blood Cell Folate Lysing Reagent Indications for Use:

The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number ___ ﺎ