(30 days)
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No
The summary describes a standard immunoassay system for measuring folate levels and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay designed to quantitatively determine folic acid levels in human samples, which assesses folate status. It does not directly treat or prevent any disease or condition; rather, it provides diagnostic information.
Yes
The device is used for the "quantitative determination of folic acid levels" in human samples, and these levels "are used to assess folate status" and can "indicate a prolonged folate deficiency," which directly supports clinical diagnosis of folate-related conditions.
No
The device description explicitly lists reagents, calibrators, lysing agent, and immunoassay analyzers as components of the system, indicating it is a hardware and reagent-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells." This involves testing biological samples in vitro (outside the body) to provide information about a person's health status (folate levels).
- Device Description: The description lists reagents, calibrators, and analyzers used to perform the test on these biological samples.
- Purpose: The purpose of measuring folate levels is to "assess folate status," which is a diagnostic purpose. Low levels can indicate a "prolonged folate deficiency."
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.
Product codes (comma separated list FDA assigned to the subject device)
CGN
Device Description
The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator S0 and the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, UniCel Dxl™ 800, and UniCel DxC 600i) comprise the Access Immunoassay Systems for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
APR 2 1 2006
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K060774
Submitter's Name and Address
Beckman Coulter. Inc. 1000 Lake Hazeltine Drive Chaska. MN 55318 Telephone: (952) 368-7869 Fax: (952) 368-7610 Contact: Carolyn Anderson
Date Prepared: March 20, 2006
Device Names
Folate on the Access® Immunoassay Systems Proprietary Name:
- Common Name: Folate test system
Classification Name: Folic Acid test system
Predicate Device
Access Folate Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Numbers: K932887, K943149, K955434
Device Description
The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator S0 and the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, UniCel Dxl™ 800, and UniCel DxC 600i) comprise the Access Immunoassay Systems for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells.
1
Intended Use
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.
| Attribute | Access Folate Assay | Access Folate Assay (modified) |
|---|---|---|
| Intended Use | Quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is and indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency. | Same |
| Methodology | Chemiluminescent immunoassay (two step competitive binding receptor assay) | Same |
| Product type | Reagent | Same |
| Sample type | Human serum, plasma (heparin) or red blood cells | Same |
| Assay components | Reagent pack, calibrators, lysing agent, Folate Calibrator S0 | Same |
| Solid Phase | Goat anti-mouse capture antibody coupled to paramagnetic particles | Same |
| Conjugate | Folic acid-alkaline phosphatase conjugate | Same |
| Calibrators | Folate (pteroylglutamic acid) in buffered matrix at levels of 0 and approximately 1.0, 2.5, 5.0, 10.0, and 20.0 ng/mL (2.3, 5.7, 11.3, 22.7, and 45.3 nmol/L) | Same |
| Reportable Range | Serum folate: 0.5 – 20 ng/mL | Serum folate: 0.5 – 20 ng/mL |
| Sample Size | 55 μL | 55 μl |
Comparison of Technological Characteristics
Summary of Technological Characteristics
The device modification consists of a change in buffers for pH adjustment and the reestablishment of the reference interval to reflect the prevalence of folic acid fortification of foods. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device.
Conclusion
The modified Access Folate on the Access Immunoassay Systems is substantially equivalent to the Access Folate assay for the quantitative determination folic acid levels in human serum, plasma (heparin) and red blood cells.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with a stylized human services symbol inside a circle. The symbol consists of three curved lines that resemble a person with outstretched arms. The text around the circle is not legible due to the image's resolution. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carolyn Anderson Schior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
APR 2 1 2006
Re: K060774
Trade/Device Name: Access Folate on the Access® Immunoassay Systems Regulation Number: 21 CFR& 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: March 20, 2006 Received: March 22, 2006
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto Gutt
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Access Folate on the Access® Immunoassay Systems
Indications For Use:
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.
Prescription Use
:
AND/OR
alary
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Hemen
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