(14 days)
Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes. • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
The provided text is a 510(k) summary for the Elecsys® Ferritin device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or a more comprehensive regulatory submission.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, data provenance, expert details, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone performance.
- Details on how ground truth was established for training and test sets.
The document is purely a summary for regulatory clearance, stating the device's function and its substantial equivalence to a previously approved device (Enzymun-Test® Ferritin), without going into the specifics of performance studies required to demonstrate that equivalence against pre-defined criteria.
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510(k) Summary
JUN – 2 1997
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| Introduction | 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. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000 |
| Contact Person: LeeAnn Chambers | |
| Date Prepared: May 15, 1997 | |
| 2) Device name | Proprietary name: Elecsys® Ferritin |
| Common name: Ferritin immunological test system | |
| Classification name: Ferritin immunological test system | |
| 3) Predicate device | We claim substantial equivalence to Enzymun-Test® Ferritin. |
| 4) Device Description | The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. |
| Total duration of assay: 18 minutes. | |
| • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. | |
| • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. | |
| Continued on next page |
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510(k) Summary, Continued
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Comments of Children Children
| 4) DeviceDescription | • The reaction mixture is aspirated into the measuring cell where themicroparticles are magnetically captured onto the surface of the electrode.Unbound substances are then removed with ProCell. Application of avoltage to the electrode then induces chemiluminescent emission which ismeasured by a photomultiplier.• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve providedvia the reagent bar code. |
|---|---|
| 5) Intended use | Immunoassay for the in vitro quantitative determination of ferritin in humanserum and plasma. |
| 6) Comparison` to predicatedevice | The Boehringer Mannheim Elecsys Ferritin is substantially equivalent toother products in commercial distribution intended for similar use. Mostnotably it is substantially equivalent to the currently marketed Enzymun-TestFerritin. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. LeeAnn Chambers, RAC Program Manager, Regulatory Affairs Boehringer Mannheim Corporation Regulatory Affairs Quality System and Compliance 9115 Hague Road Indianapolis, Indiana 46250
Re: K971833 Trade Name: Elecsys® Ferritin Regulatory Class: II Product Code: JMG Dated: May 15, 1997 Received: May 19, 1997
Dear Ms. Chambers:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 Regulations.
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 (770)488-7655.
UN - 2 1997
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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 yitto diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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® Ferritin Indications for Use:
Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
Peter E. Madini
Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).