(90 days)
Not Found
No
The description details a standard chemiluminescent immunoassay and does not mention any AI or ML components.
No
This device is an immunoassay intended for in vitro diagnostic use to measure erythropoietin levels, aiding in the diagnosis of anemias and polycythemias. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the assay is "intended as an aid in the diagnosis of anemias and polycythemias."
No
The device is a paramagnetic particle, chemiluminescent immunoassay, which is a laboratory test kit involving physical reagents and processes, not solely software.
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 erythropoietin levels in human serum and plasma and is "intended as an aid in the diagnosis of anemias and polycythemias." This clearly indicates that the device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" that measures a substance (erythropoietin) in human samples (serum and plasma). This is a typical description of an in vitro diagnostic test.
- Calibration: The description mentions "Access EPO Calibrators" which are used to calibrate the assay for quantitative determination of EPO levels in human samples. Calibration is a standard process for quantitative IVD tests to ensure accurate measurements.
- Assay Method: The detailed description of the "two-site immunoenzymatic ('sandwich') assay" involving paramagnetic particles, antibodies, and a chemiluminescent substrate is a common methodology used in IVD tests to detect and quantify specific analytes in biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, a state of health or disease, or a congenital abnormality.
N/A
Intended Use / Indications for Use
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
Product codes (comma separated list FDA assigned to the subject device)
GGT
Device Description
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. 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 tested 141 native and 11 spiked samples across three Access 2 Immunoassay Systems and three Dxl 9000 Access Immunoassay Analyzers.
N: 152
Concentration Range (mIU/mL): 0.79 - 697
Slope: 0.99
Slope 95% CI: 0.97 – 1.00
Intercept: -0.040
Intercept 95% CI: (-0.19) - 0.22
Correlation Coefficient R: 1.00
Imprecision: A study based on CLSI EP05-A3 performed on each of four Dxl 9000 Access Immunoassay Analyzers tested four native samples and one spiked sample in duplicate in 2 runs per day for 20 days.
The assay was designed to have within-laboratory imprecision as listed below:
- 3.0 mIU/mL
Sample 1: Mean 2.0, Repeatability SD 0.05, Repeatability %CV 2.3, Between-run SD 0.02, Between-run %CV 1.0, Between-day SD 0.06, Between-day %CV 2.8, Within-Laboratory SD 0.07, Within-Laboratory %CV 3.8
Sample 2: Mean 18, Repeatability SD 0.2, Repeatability %CV 1.2, Between-run SD 0.1, Between-run %CV 0.5, Between-day SD 0.5, Between-day %CV 2.7, Within-Laboratory SD 0.5, Within-Laboratory %CV 3.0
Sample 3: Mean 105, Repeatability SD 2.2, Repeatability %CV 2.2, Between-run SD 1.0, Between-run %CV 1.0, Between-day SD 1.4, Between-day %CV 1.4, Within-Laboratory SD 2.8, Within-Laboratory %CV 2.7
Sample 4: Mean 267, Repeatability SD 4.9, Repeatability %CV 1.8, Between-run SD 1.2, Between-run %CV 0.4, Between-day SD 3.8, Between-day %CV 1.4, Within-Laboratory SD 6.3, Within-Laboratory %CV 2.4
Sample 5: Mean 548, Repeatability SD 9.3, Repeatability %CV 1.7, Between-run SD 0.0, Between-run %CV 0.003, Between-day SD 18.1, Between-day %CV 3.3, Within-Laboratory SD 20.4, Within-Laboratory %CV 3.7
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.
Limit of Blank (LoB): The claimed LoB for Access assay is 0.6 mIU/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The claimed LoD for Access assay is 0.6 mIU/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The claimed LoQ for Access assay is 0.6 mlU/mL on Dxl 9000 Access Immunoassay Analyzer.
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.
Not Found
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
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 22, 2024
Beckman Coulter Inc Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240182
Trade/Device Name: Access EPO Regulation Number: 21 CFR 864.7250 Regulation Name: Erythropoietin Assay Regulatory Class: Class II Product Code: GGT Dated: January 22, 2024 Received: January 23, 2024
Dear Kate Oelberg:
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"
1
K240182 - Kate Oelberg
(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).
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 QS 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) 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 (QS) 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, Min Wu
Min Wu, 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) K240182
Device Name Access EPO
Indications for Use (Describe)
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 K240182
Submitted Bv:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primarv Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberg@beckman.com
Alternate Contact:
Kuljeet Kaur Senior Manager, Regulatory Affairs Phone: (952) 368-7816 Email: kkaur@beckman.com
Device Name
Common Name: Access EPO Trade Name: Access EPO Reagent on Dxl 9000 Access Immunoassay Analyzer Classification Name: Ervthropoietin assay Classification Requlation: [21 CFR 864.7250]
Predicate Device
Device Name: Access EPO 510(k) Numbers: K052223
Device Description
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate.
4
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 EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
| Parameter | Access EPO Assay on Access 2
Immunoassay System (Predicate) | Access EPO Assay on Dxl 9000
Access Immunoassay System |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended use | The Access EPO assay is a
paramagnetic particle, chemiluminescent
immunoassay for the quantitative
determination of erythropoietin levels in
human serum and plasma (heparin) using
the Access Immunoassay Systems. This
assay is intended as an aid in the
diagnosis of anemias and polycythemias. | Same |
| Technology | 2-site (sandwich) chemiluminescent | Same |
| Format | Chemiluminescent | Same |
| Calibration | Utilizes a stored multi-point calibration
curve
Calibrators are provided at six levels –
zero and approximately 5, 25, 125, 375
and 750 mIU/mL | Same |
| Sample Type | Serum and plasma (heparin) | Same |
| Measuring
Range | 0.6-750 mIU/L | Same |
| Instrument | Access Immunoassay system | Dxl 9000 Access Immunoassay
Analyzer |
| Substrate | Access Substrate | Lumi-Phos Pro Substrate |
Comparison of Technological Characteristics to the Predicate
Standard/Guidance Document Referenced (if applicable):
5
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 30 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 tested 141 native and 11 spiked samples across three Access 2 Immunoassay Systems and three Dxl 9000 Access Immunoassay Analyzers.
| N | Concentration
Range*
(mIU/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 152 | 0.79 - 697 | 0.99 | 0.97 – 1.00 | -0.040 | (-0.19) - 0.22 | 1.00 |
*Range is Access 2 values
Imprecision: The assay was designed to have within-laboratory imprecision as listed below:
- ≤ 0.30 mIU/mL SD at concentrations ≤ 3.0 mIU/mL
- ≤ 10.0% CV at concentrations > 3.0 mlU/mL
A study based on CLSI EP05-A3performed on each of four Dxl 9000 Access Immunoassay Analyzers tested four native samples and one spiked sample in duplicate in 2 runs per day for 20 days.
| Concentration (mIU/L) | | Repeatability
(Within-run) | | Between-run | | Between-
day | | Within-
Laboratory | | |
|-----------------------|----|-------------------------------|------|-------------|------|-----------------|------|-----------------------|------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 2.0 | 0.05 | 2.3 | 0.02 | 1.0 | 0.06 | 2.8 | 0.07 | 3.8 |
| Sample 2 | 80 | 18 | 0.2 | 1.2 | 0.1 | 0.5 | 0.5 | 2.7 | 0.5 | 3.0 |
| Sample 3 | 80 | 105 | 2.2 | 2.2 | 1.0 | 1.0 | 1.4 | 1.4 | 2.8 | 2.7 |
| Sample 4 | 80 | 267 | 4.9 | 1.8 | 1.2 | 0.4 | 3.8 | 1.4 | 6.3 | 2.4 |
| Sample 5 | 80 | 548 | 9.3 | 1.7 | 0.0 | 0.003 | 18.1 | 3.3 | 20.4 | 3.7 |
6
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.
Limit of Blank (LoB): The claimed LoB for Access assay is 0.6 mIU/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The claimed LoD for Access assay is 0.6 mIU/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The claimed LoQ for Access assay is 0.6 mlU/mL on Dxl 9000 Access Immunoassay Analyzer.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access EPO Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access EPO 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.