(265 days)
Not Found
No
The summary describes a standard immunoassay for measuring folate levels and does not mention any AI or ML components. The performance studies focus on analytical characteristics like imprecision, linearity, and method comparison, which are typical for laboratory assays.
No.
The device is an immunoassay for the quantitative determination of folic acid levels, used in diagnosis and assessment of folate status, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia." This indicates that the device provides information for medical diagnosis.
No
The device is an immunoassay kit used with an immunoassay system, which are hardware components, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells". This involves testing biological samples in vitro (outside the body).
- Diagnosis and Treatment: The intended use also states that the measurements are "used in the diagnosis and treatment of megaloblastic anemia". This directly links the test results to clinical decision-making for a specific medical condition.
- Sample Types: The device analyzes human serum, plasma, and red blood cells, which are all biological specimens.
- Method: The device uses a "paramagnetic particle, chemiluminescent immunoassay", which is a common technique used in IVD testing.
- Prescription Use: The "Intended User / Care Setting" indicates "Prescription Use", which is typical for IVD devices used in a clinical setting.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
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, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.
Product codes
CGN
Device Description
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and lithium heparin plasma or red blood cells using the Access Immunoassay Systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Method Comparison: The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.12 and supports the equivalence of the Access Folate assay on Dxl 9000 to the predicate device, the Access Folate assay on Access 2 Instrument. N=123, Concentration Range=1.4 - 25 ng/mL, Slope=1.04 (95% CI: 1.01 - 1.07), Intercept=0.081 (95% CI: -0.074 - 0.19), Correlation Coefficient R=0.99.
Linearity: A verification study was performed to evaluate the linearity of the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The results met the acceptance criterion, indicating linearity throughout the analytical measuring interval (2.0 - 24.8 ng/mL).
Serum Imprecision: Verification studies were performed to determine the imprecision of the Access Folate assay for serum samples on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was run on three Dxl 9000 Immunoassay analyzers, three reagent lots, and three calibrator lots. Five (5) serum samples were assayed in duplicate with two runs per day, over 20-22 days. The within-laboratory (total) % CV was between 2.2% and 4.4% for Folate concentrations > 2.0 ng/mL. The within-laboratory (total) SD was between 0.10 - 0.21 for Folate concentrations ≤ 2.0 ng/mL. The repeatability (within-run) % CV was between 1.6% and 2.7% for Folate concentrations > 2.0 ng/mL. The repeatability (within-run) SD was between 0.08 -0.09 for Folate concentrations ≤ 2.0 ng/mL. Sample N=88.
RBC Imprecision: Verification studies were performed to determine the imprecision of the Access Folate assay for hemolysate samples on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was run on one Dxl 9000 Access Immunoassay Analyzer, one reagent lot, and one calibrator lot. Six whole blood hemolysate samples were tested. The within-laboratory (total) % CV ranged from 1.9% to 4.9%. Sample N=80.
LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) for the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The assay is designed to meet the claimed LoB of 0.80 ng/mL (1.81 nmol/L), LoD of 1.0 ng/mL (2.27 nmol/L).
LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) for the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The LoQ for Access Folate is designed to meet the claimed LoQ of
§ 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.
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August 23, 2023
Beckman Coulter, Inc. Kuljeet Kaur Regulatory Affairs Manager 1000 Lake Hazeline Drive Chaska, Minnesota 55318
Re: K223590
Trade/Device Name: Access Folate Assay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic Acid Test System Regulatory Class: Class II Product Code: CGN Dated: November 30, 2022 Received: July 27, 2023
Dear Kuljeet Kaur:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223590
Device Name Access Folate Assay
Indications for Use (Describe)
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Access Folate Assay 510(k) Summary
510(k) Number: K223590
Date Prepared: Aug 21, 2023
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Kuljeet Kaur Regulatory Affairs Manager Phone: (952)-465-1914 Email: kkaur@beckman.com
Alternate Contact:
Madhuri Boppana Senior Regulatory Affairs Analyst Email: mboppana@beckman.com
Common Name: Folate test system Trade Name: Access Folate Assay Classification Name: Folic acid test system Classification Requlation: 21 CFR 862.1295 Classification Product Code: CGN
Predicate Device: Device Name: Access Folate Assay 510(k) Numbers: Primary predicate: K060774, Secondary predicate: K111952
Device Description:
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and lithium heparin plasma or red blood cells using the Access Immunoassay Systems.
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Intended Use:
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.
| System
Attribute/Characteristic | Predicate Access
Immunoassay Systems
(K060774) | Access Folate on Dxl
9000 Access
Immunoassay
Analyzer |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use/Indications
for Use | The Access Folate assay is a
paramagnetic particle,
chemiluminescent immunoassav
for the quantitative determination
of folic acid levels in human serum
and plasma (heparin) or red blood
cells using the Access
Immunoassay Systems. | Same |
| Analyte Measured | Access Folate | Same |
| Technology | Competitive binding Immunoassay
System | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum, plasma, or red blood cells | Same |
| Stability | Stable at 2 to 10°C for 14 days
after initial use | Same |
| Instrument | Access 2 Immunoassay System | DxI 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO |
| Measuring Range | 1.0 - 24.8 ng/mL | 2.0 - 24.8 ng/mL |
Comparison of Technological Characteristics to the Predicate
Comparison of Technological Characteristics to the Predicate
| System
Attribute/Characteristic | Predicate Access
Immunoassay Systems
(K111952) | Access Folate on Dxl
9000 Access
Immunoassay Analyzer |
|------------------------------------|------------------------------------------------------------|-------------------------------------------------------------|
| Standardization | World Health Organization
(WHO) International Standards | Same |
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Summary of Studies:
Method Comparison: The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.12 and supports the equivalence of the Access Folate assay on Dxl 9000 to the predicate device, the Access Folate assay on Access 2 Instrument. The estimated bias at concentration corresponding to reference limits defined on the predicate system suggest that such values have not changed appreciably on the Dxl 9000 analyzer.
| N | Concentration Range* (ng/mL) | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation Coefficient R |
|---|---|---|---|---|---|---|
| 123 | 1.4 - 25 | 1.04 | 1.01 - 1.07 | 0.081 | -0.074 - 0.19 | 0.99 |
*Range is Access 2 values
Linearity: A verification study was performed to evaluate the linearity of the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The results of this study met the acceptance criterion, indicating that the Access Folate assay is linear on the Dxl 9000 Immunoassay Analyzer throughout the analytical measuring interval (2.0 - 24.8 ng/mL).
Serum Imprecision: Verification studies were performed to determine the imprecision of the Access Folate assay for serum samples on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was run on three Dxl 9000 Immunoassay analyzers, three reagent lots, and three calibrator lots. Five (5) serum samples, with varying Folate concentrations, were assayed in duplicate with two runs per day, over 20-22 days. The study met the minimum requirement of 80 replicates per sample on each instrument and reagent lot combination. The within-laboratory (total) % CV was between 2.2% and 4.4% for Folate concentrations > 2.0 ng/mL. The within-laboratory (total) SD was between 0.10 - 0.21 for Folate concentrations ≤ 2.0 nq/mL.
The repeatability (within-run) % CV was between 1.6% and 2.7% for Folate concentrations > 2.0 ng/mL. The repeatability (within-run) SD was between 0.08 -0.09 for Folate concentrations ≤ 2.0 ng/mL.
| Serum Folate
(ng/mL) | | Repeatability
(Within-Run) | | Between-Run | | | Between-Day | | Within-
Laboratory | |
|-------------------------|----|-------------------------------|------|-------------|------|-----|-------------|-----|-----------------------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 88 | 1.7 | 0.09 | N/A | 0.10 | N/A | 0.16 | N/A | 0.21 | N/A |
| Sample 2 | 88 | 4.7 | 0.10 | 2.1 | 0.07 | 1.4 | 0.17 | 3.6 | 0.21 | 4.4 |
| Sample 3 | 88 | 9.2 | 0.25 | 2.7 | 0.00 | 0.0 | 0.27 | 2.9 | 0.36 | 3.9 |
| Sample 4 | 88 | 16 | 0.3 | 2.0 | 0.2 | 1.2 | 0.4 | 2.7 | 0.6 | 3.6 |
| Sample 5 | 88 | 21 | 0.4 | 2.1 | 0.3 | 1.3 | 0.6 | 2.7 | 0.8 | 3.7 |
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RBC Imprecision: Verification studies were performed to determine the imprecision of the Access Folate assay for hemolysate samples on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was run on one Dxl 9000 Access Immunoassay Analyzer, one reagent lot, and one calibrator lot. Six whole blood hemolysate samples, with varying Folate concentrations, were tested in the study. The within-laboratory (total) % CV ranged from 1.9% to 4.9%.
| Hemolysate Folate
Concentration (ng/mL) | | Repeatability
(Within-run) | | Between-run | | Between-
day | | Within-
Laboratory | | |
|--------------------------------------------|----|-------------------------------|------|-------------|------|-----------------|------|-----------------------|------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 5.0 | 0.21 | 4.3 | 0.00 | 0.004 | 0.00 | 0.001 | 0.21 | 4.3 |
| Sample 2 | 80 | 11 | 0.3 | 2.8 | 0.3 | 2.8 | 0.0 | 0.02 | 0.5 | 4.0 |
| Sample 3 | 80 | 11 | 0.5 | 4.4 | 0.0 | 0.02 | 0.2 | 2.2 | 0.5 | 4.9 |
| Sample 4 | 80 | 13 | 0.2 | 1.9 | 0.1 | 0.5 | 0.0 | 0.002 | 0.3 | 1.9 |
| Sample 5 | 80 | 18 | 0.4 | 2.2 | 0.3 | 1.8 | 0.3 | 1.4 | 0.6 | 3.1 |
| Sample 6 | 80 | 22 | 0.4 | 1.8 | 0.3 | 1.2 | 0.0 | 0.003 | 0.5 | 2.1 |
LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) for the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The assay is designed to meet the claimed LoB of 0.80 ng/mL (1.81 nmol/L), LoD of 1.0 ng/mL (2.27 nmol/L).
LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) for the Access Folate assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The LoQ for Access Folate is designed to meet the claimed LoQ of