(84 days)
No
The description details a standard immunoassay technology and mentions automated determination from a stored calibration, which is not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like image processing, training sets, or complex algorithms beyond standard analytical calculations.
No.
This device is an immunoassay intended for in vitro diagnostic use to measure sTfR levels and aid in the diagnosis and differential diagnosis of iron deficiency anemia and anemia of chronic disease. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)".
No
The device description clearly outlines a physical assay reagent pack containing chemical components and paramagnetic particles, which are hardware. The process involves physical steps like incubation, magnetic separation, and measurement using a luminometer, indicating a hardware-dependent system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma. It also states that it is "intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a laboratory assay that uses chemical and biological reagents to measure an analyte (sTfR) in a biological sample (serum and plasma). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The inclusion of performance studies like Method Comparison, Imprecision, Linearity, and Detection Capability, all conducted according to CLSI guidelines, further supports its classification as an IVD. These studies are standard for demonstrating the analytical performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K080634) and the name "Access sTfR" indicates that this device is being compared to a previously cleared IVD. This is a common regulatory pathway for new IVDs.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
Product codes
DDG
Device Description
Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.
The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Method Comparison:
A study based on CLSI EP09c, 3rd Edition using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
N: 200, Concentration Range: 0.10 - 142 nmol/L, Slope: 1.00, 95% CI Slope: 0.99 – 1.01, Intercept: -0.016, 95% CI Intercept: -0.14 - 0.15, Correlation Coefficient R: 1.00.
Imprecision:
A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
The assay was designed to have within-laboratory imprecision as listed below:
- 9 nmol/L
Linearity:
A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Detection Capability:
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2.
Limit of Blank (LoB): 0.04 nmol/L
Limit of Detection (LoD): 0.05 nmol/L
Limit of Quantitation (LoQ): 0.05 nmol/L at
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
0
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July 3, 2024
Beckman Coulter Inc. Neha Desai Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240987
Trade/Device Name: Access sTfR Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG Dated: April 10, 2024 Received: April 10, 2024
Dear Neha Desai:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240987
Device Name Access sTfR
Indications for Use (Describe)
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
| 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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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.
510(k) Number K240987
Submitted Bv:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primarv Contact:
Neha Desai Staff Quality and Regulatory Affairs Phone: (612) 244-9788 Email: nhdesai@beckman.com
Alternate Contact:
Kuljeet Kaur Senior Manager, Regulatory Affairs Phone: (952) 368-7816 Email: kkaur@beckman.com
Device Name
Common Name: Access sTfR Trade Name: Access sTfR on Dxl 9000 Access Immunoassay Analyzer Classification Name: Transferrin immunological test system Classification Requlation: [21 CFR 866.5880]
Predicate Device
Device Name: Access sTfR 510(k) Numbers: K080634
Device Description
Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.
The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on
4
the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Intended Use
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with an Access Ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
| Parameter | Access sTfR Assay on Access 2
Immunoassay System (Predicate) | Access sTfR Assay on
Dxl 9000 Access
Immunoassay System |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended use | The Access sTfR assay is a
paramagnetic particle, chemiluminescent
immunoassay for the quantitative
determination of soluble transferrin
receptor (sTfR) levels in human serum
and plasma (heparin) using the Access
Immunoassay Systems. The assay is
intended as an aid in the diagnosis of
Iron Deficiency Anemia (IDA), and for the
differential diagnosis of IDA and Anemia
of Chronic Disease (ACD).
This assay may also be used in
conjunction with an Access Ferritin
measurement to provide a calculated
sTfR/log ferritin index. This index is
intended as an aid in the diagnosis of
IDA, and for the differential diagnosis of
IDA and ACD. | Same |
| Technology | 2-site (sandwich) chemiluminescent | Same |
Comparison of Technological Characteristics to the Predicate
5
| Parameter | Access sTfR Assay on Access 2
Immunoassay System (Predicate) | Access sTfR Assay on
Dxl 9000 Access
Immunoassay System |
|--------------------|-----------------------------------------------------------------|---------------------------------------------------------------|
| Format | Chemiluminescent | Same |
| Calibration | Utilizes a stored multi-point calibration
curve | Same |
| Sample Type | Serum and plasma (heparin) | Same |
| Measuring
Range | 3.0 to 150 nmol/L | 0.05 – 150 nmol/L |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos Pro Substrate |
Standard/Guidance Document Referenced (if applicable):
These standards can be copied or found from regulatory submission reports:
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
CLSI EP06-2nd Edition : Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition
Summary of Studies
Method Comparison:
A study based on CLSI EP09c, 3rd Edition using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
| N | Concentration
Range*
(nmol/L) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | Correlation
Coefficient R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|------------------------------|
| 200 | 0.10 - 142 | 1.00 | 0.99 – 1.01 | -0.016 | -0.14 - 0.15 | 1.00 |
*Range is Access 2 values
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Imprecision:
The assay was designed to have within-laboratory imprecision as listed below:
- ≤ 0.72 nmol/L SD at concentrations ≤ 9 nmol/L
• ≤ 8.0% CV at concentrations > 9 nmol/L
A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
| Concentration (nmol/L) | Repeatability (Within-run) | Between-run | Between-day | Within- Laboratory (Total) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Sample 1 | 80 | 9.1 | 0.15 | 1.6 | 0.10 | 1.1 | 0.15 | 1.7 | 0.24 | 2.6 | |
| Sample 2 | 80 | 17 | 0.3 | 1.8 | 0.3 | 1.7 | 0.1 | 0.8 | 0.5 | 2.6 | |
| Sample 3 | 80 | 20 | 0.4 | 2.0 | 0.0 | 0.01 | 0.3 | 1.3 | 0.5 | 2.4 | |
| Sample 4 | 80 | 33 | 0.4 | 1.2 | 0.4 | 1.1 | 0.2 | 0.7 | 0.6 | 1.8 | |
| Sample 5 | 80 | 67 | 0.7 | 1.1 | 0.4 | 0.6 | 1.1 | 1.6 | 1.4 | 2.0 | |
| Sample 6 | 80 | 118 | 1.5 | 1.3 | 1.2 | 1.0 | 1.6 | 1.4 | 2.6 | 2.2 |
Linearitv:
A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Detection Capability:
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2.
| nmol/L | |
|---|---|
| Limit of Blank (LoB) | 0.04 |
| Limit of Detection (LoD) | 0.05 |
| Limit of Quantitation (LoQ) | 0.05 |
| ≤ 20% within-lab CV |
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access sTfR Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access sTTR Assay on the Access 2 Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.