ELECSYS FOLATE

K973674 · Boehringer Mannheim Corp. · CDD · Nov 12, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973674
• Device Name: ELECSYS FOLATE
• Applicant: Boehringer Mannheim Corp.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

Assay for the in vitro quantitative determination of folate in human serum. The visual "ECLIA" is intended for use on the Boehringer Mannheim Elecsys assay analyzers.

Device Story

Elecsys FOLATE is an electrochemiluminescent immunoassay (ECLIA) for quantitative folate determination in human serum. Input: 15 µl serum sample. Process: 18-minute sandwich assay involving sample pretreatment to liberate bound folate, incubation with ruthenylated folate binding protein, and addition of streptavidin-coated microparticles and biotinylated folate. Microparticles are magnetically captured on an electrode; unbound substances are washed away. Voltage application induces chemiluminescent emission measured by a photomultiplier. Output: Folate concentration calculated via instrument-specific calibration curve and master curve from reagent bar code. Used in clinical laboratories on Elecsys assay analyzers. Benefits: Provides quantitative folate levels to assist clinicians in patient diagnosis and management.

Clinical Evidence

Performance studies included evaluation of assay precision per NCCLS recommendations, determination of lower detection limit, linearity, and correlation with the predicate device. Interference studies evaluated the effect of endogenous substances (biotin, triglyceride, lipemia, rheumatoid factor) and common pharmaceutical compounds. Stability studies were also performed.

Technological Characteristics

Electrochemiluminescent immunoassay (ECLIA) using sandwich principle. Components: Ruthenylated folate binding protein, streptavidin-coated microparticles, biotinylated folate. Detection: Photomultiplier tube measuring chemiluminescent emission upon voltage application to electrode. Connectivity: Instrument-specific calibration via reagent bar code. Form factor: Reagent kit for use on Elecsys assay analyzers.

Indications for Use

Indicated for the in vitro quantitative determination of folate in human serum for clinical laboratory use.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Bio-Rad Quantaphase II® B12/FOLATE Radioassay (K935286)

Submission Summary (Full Text)

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## DUPLICATE

K973674

## 510(k) Summary

NOV 1 2 1997

| | 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. |
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BOEHRINGER MANNHEIM CORPORATIONinduction

| 1) Submitter name, address, contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94588-2722<br>[phone]<br><br>Contact Person: Patricia M. Klimley<br>Date Prepared: September 24, 1997 |
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| 2) Device name | Proprietary name: Elecsys® FOLATE<br>Common name: Electrochemiluminescent assay for the determination of FOLATE.<br>Classification name: Folate Test System. |
| 3) Predicate device | We claim substantial equivalence to the Bio-Rad Quantaphase II® B12/FOLATE Radioassay (K935286). |
| 4) Device Description | The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes.<br>● 1st Incubation (9 min.): 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.<br>● 2nd Incubation (9 min.): By incubating the pretreated sample with the Ruthenylated folate binding protein (80 µl), an FBP-folate complex is formed, the amount of which is dependent upon the analyte concentration in the sample.<br>● 3rd incubation (9 min.): after the addition of streptavidin-coated microparticles (30 µl) and folate labeled with biotin (50 µl), the unbound sites of the Ruthenylated folate binding protein become occupied, with formation of a Ruthenylated folate binding protein-folate biotin complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. |

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## 510(k) Summary, Continued

| 510(k) Summary, Continued | |
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| BOEHRINGER<br>MANNHEIM<br>CORPORATION | Image: boehringer logo |
| 4) Device<br>Description,<br>cont. | The reaction mixture is aspirated into the measuring cell where the<br>microparticles are magnetically captured onto the surface of the electrode.<br>Unbound substances are then removed by washing with ProCell.<br>Application of a voltage to the electrode then induces chemiluminescent<br>emission which is measured by a photomultiplier (0.4 second read frame). Results are determined via a calibration curve which is instrument-specific<br>generated by 2-point calibration and a master curve provided via the<br>reagent bar code. |
| 5) Intended use | Assay for the in vitro quantitative determination of folate in human serum. |
| 6) Comparison<br>to predicate<br>device | The Boehringer Mannheim Elecsys FOLATE is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably it is substantially equivalent to the currently marketed Bio-Rad<br>Quantaphase II® B12/FOLATE Radioassay (K935286).<br>Studies performed include: evaluation of assay precision according to NCCLS recommendations determination of the lower detection limit demonstration of linearity correlation with the predicate device evaluation of the effect of various endogenous substances (biotin,<br>triglyceride, lipemia, and rheumatoid factor), and commonly used<br>pharmaceutical compounds and serum sample comparisons, and stability studies. |

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia M. Klimley Head, Elecsys Regulatory Program Boehringer Mannheim Corporation 4300 Hacienda Drive Pleasanton, California 94588-2722

NOV 1 2 1997

Re: K973674 Trade Name: Elecsys® FOLATE Regulatory Class: II Product Code: CDD Dated: September 24, 1997 Received: September 26, 1997

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, Drug, and Cosmetic Act (Act). 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 (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 requirement, 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 regulation may result in regulatory 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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® FOLATE Indications for Use:

Assay for the in vitro quantitative determination of folate in human serum. Fisody for are in The visual "ECLIA" is intended for use on the Boehringer Mannheim Elecsys assay analyzers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KC973674

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)