(84 days)
No
The summary describes a laboratory reagent and assay kit for measuring folate in red blood cells using an immunoassay analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a reagent used in combination with an immunoassay for the quantitation of folate in human red blood cells, indicating it is an in vitro diagnostic product, not a therapeutic device.
Yes
The device is used for the "quantitation of folate in human red blood cells," which provides information on a patient's health status related to folate levels. This falls under the definition of a diagnostic device as it measures a physiological parameter to aid in diagnosis or monitoring.
No
The device description clearly outlines a reagent and assay kit used with a specific immunoassay analyzer, indicating it is a chemical and hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent is used "for the quantitation of folate in human red blood cells." This is a measurement performed in vitro (outside the body) on a biological sample (red blood cells) to provide information about a patient's health status (folate levels).
- Device Description: The description details a laboratory assay ("electrochemiluminescence assay 'ECLIA'") performed on an analyzer ("Boehringer Mannheim Elecsys 2010 immunoassay analyzer"). This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The sample is "human red blood cells," which is a biological specimen taken from the body for analysis.
- Predicate Device: The predicate device is a "Radiobinding assay," which is another type of in vitro diagnostic test for measuring folate.
- Reference Device: The reference device is the "Elecsys® Folate Assay," which is the core assay this lysing reagent is used with, and is also an in vitro diagnostic test.
All these elements point to the device being used to perform a diagnostic test on a biological sample outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CGN
Device Description
The Elecsys® test principle is based on the competitive principle. Total 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human red blood cells
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Elecsys studies performed include:
• evaluation of assay precision according to NCCLS recommendations
• demonstration of linearity
• correlation with the predicate device
• sample type studies
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1295 Folic acid test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '981931', and ends with a vertical line. The characters are written in a dark ink, and the background is white.
510(k) Summary
| 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 | Roche Diagnostics/Boehringer Mannheim Corporation
4300 Hacienda Drive
Pleasanton, CA 94566-0900
(925) 730-8215
Contact Person: Patricia M. Klimley
Date Prepared: June 1, 1998 |
| 2) Device name | Proprietary name: Elecsys® Red Blood Cell Folate Lysing Reagent
Common name: 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.
Classification name: Folate Test System. |
| 3) Predicate
device | We claim substantial equivalence to the Bio-Rad Quantaphase II® FOLATE
Radiobinding assay (K935286). |
| 4) Device
Description | The Elecsys® test principle is based on the competitive principle. Total
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
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. |
| 6) Comparison
to predicate
device | The Roche Diagnostics/Boehringer Mannheim Elecsys Red Blood Cell Folate
is substantially equivalent to other products in commercial distribution
intended for similar use. Most notably it is substantially equivalent to the
currently marketed Bio-Rad Quantaphase II® Folate Radiobinding assay . |
| | Elecsys studies performed include:
• evaluation of assay precision according to NCCLS recommendations
• demonstration of linearity
• correlation with the predicate device
• sample type studies |
Continued on next page
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510(k) Summary, Continued
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.
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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Page 2
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.
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 (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 qeneral 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 (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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