(80 days)
Not Found
No
The summary describes a standard immunoassay for measuring CA 125 levels and does not mention any AI or ML components in the device description or performance studies.
No
This device is an in vitro diagnostic (IVD) test that measures CA 125 antigen levels to aid in the management of ovarian cancer patients. It does not provide treatment or directly restore function, which are characteristics of therapeutic devices.
Yes
The device quantitatively determines CA 125 antigen levels to aid in the management of ovarian cancer patients, which indicates its use in aiding in diagnosis or monitoring of a disease.
No
The device description explicitly states that the device consists of a reagent pack and calibrators, which are physical components, and is designed for use with a specific hardware analyzer (Dxl 9000 Access Immunoassay Analyzer). This indicates it is not a software-only device.
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 CA 125 antigen levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "sandwich immunoenzymatic assay" using reagents and calibrators, which are components typical of in vitro diagnostic tests.
- Clinical Laboratory Setting: The device is designed for use in a "clinical laboratory setting," which is where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Linearity, Limit of Blank, Limit of Detection, Limit of Quantitation) are all standard analytical performance studies conducted for in vitro diagnostic devices.
- Predicate Device: The mention of a "predicate device" with a K number (K023597) indicates a comparison to a previously cleared in vitro diagnostic device.
All of these points strongly indicate that the Access OV Monitor assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Product codes (comma separated list FDA assigned to the subject device)
LTK
Device Description
The Access OV Monitor assay is a sandwich immunoenzymatic assay. The Access OV Monitor assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access OV Monitor assay reagent pack, Access OV Monitor assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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
clinical laboratory setting.
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 method comparison study was performed to compare the Access OV Monitor assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred fifty-two (152) samples falling within the measuring range of the Access OV Monitor assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.09.
Imprecision: A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in triplicate in 2 runs per day for a minimum of 20 days. On the Dxl 9000 Access Immunoassav Analyzer, the within-laboratory (total) % CV ranged from 2.6% to 6.1%, for OV Monitor concentrations > 15 U/mL and the within-laboratory SD of 0.2 for a sample concentration ≤ 15 U/mL was observed.
Linearity: A verification study was performed to evaluate the linearity of the Access OV Monitor assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access OV Monitor assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 2.0 - 5,000 U/mL.
Limit of Blank (LoB): The LoB for Access OV Monitor assay is 0.5 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The LoD estimate for the Access OV Monitor assay is 0.7 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The maximum LoQ determined for the Access OV Monitor assay is 2.0 U/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
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2024
Beckman Coulter, Inc Kuljeet Kaur Senior Manager Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240479
Trade/Device Name: Access OV Monitor Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: LTK Dated: February 19, 2024 Received: February 20, 2024
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 (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
Submission Number (if known)
K240479 Device Name
Access OV Monitor
Indications for Use (Describe)
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access lmmunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
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
Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, followed by the company name "BECKMAN COULTER" in bold, black letters. The word "BECKMAN" is stacked on top of the word "COULTER".
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
510(k) Number: K240479
Date Prepared: May 01, 2024
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kuljeet Kaur, Senior Regulatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Alternate Contact:
Kate Oelberg, Senior Staff Quality and Regulatory Affairs Email: kmoelberg@beckman.com Phone: (612) 431-7315
Trade Name: Access OV Monitor Common Name: OV Monitor Chemiluminescence Immunoassay Classification Regulation: 21 CFR 866.6010 Classification Product Code: LTK
Predicate Device:
Access OV Monitor 510(k) Number K023597
Device Description
The Access OV Monitor assay is a sandwich immunoenzymatic assay. The Access OV Monitor assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access OV Monitor assay reagent pack, Access OV Monitor assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Intended Use
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA
4
125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
| System
Attribute/Characteristic | Predicate Access OV Monitor assay
(K023597) run on the Access
Immunoassay System | Access OV Monitor
assay run on the Dxl
9000 Access
Immunoassay
Analyzer Instrument |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Access OV Monitor assay is a
paramagnetic particle,
chemiluminescent immunoassay for
the quantitative determination of CA
125 antigen levels in human serum
and plasma using the Access
Immunoassay Systems. This device is
indicated for use in the measurement
of CA 125 antigen to aid in the
management of ovarian cancer
patients. Serial testing for patient CA
125 antigen concentrations should be
used in conjunction with other clinical
methods used for monitoring ovarian
cancer. | Same |
| Analyte Measured | CA 125 | Same |
| Standardization | Working Calibrators | Same |
| Technology | chemiluminescent | Same |
| Format | Sandwich Immunoassay | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum/Plasma | Same |
| Stability | 28 days after opening | Same |
| Reagent Pack
formulation and
packaging | Access Reagent Pack formulation and
packaging. | Same |
| Reagent Configurations | One Configuration:
100 determinations, 2 packs, 50
tests/pack | Same |
| Measuring Range | 0.5 - 5000 U/mL | 2.0 - 5,000 U/mL |
| Sample Volume | 25 uL | 30 uL |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO
substrate |
Comparison of Technological Characteristics to the Predicate (Assay)
5
Standard/Guidance Document Referenced (if applicable):
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: Measurement Procedure Comparison and Bias Estimation Using Patient Samples- Third Edition
Summary of Studies:
Method Comparison: A method comparison study was performed to compare the Access OV Monitor assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred fifty-two (152) samples falling within the measuring range of the Access OV Monitor assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.09.
| N | Concentration
Range*
(U/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | R2 |
|-----|-----------------------------------|-------|-----------------|-----------|---------------------|------|
| 152 | 2.4 - 5001 | 0.98 | 0.97 - 0.99 | -0.14 | -0.38 - 0.13 | 1.00 |
*Range is Access 2 values
Imprecision: A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in triplicate in 2 runs per day for a minimum of 20 days. On the Dxl 9000 Access Immunoassav Analyzer, the within-laboratory (total) % CV ranged from 2.6% to 6.1%, for OV Monitor concentrations > 15 U/mL and the within-laboratory SD of 0.2 for a sample concentration ≤ 15 U/mL was observed.
| Concentration (U/mL) | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory
(Total) | | |
|----------------------|-----|-------------------------------|-------|-------------|------|-------------|-------|----------------------------------|-------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 120 | 5.5 | 0.1 | 1.7 | 0.1 | 1.6 | 0.2 | 3.4 | 0.2 | 4.1 |
| Sample 2 | 120 | 54 | 1.6 | 2.9 | 0.0 | 0.0 | 1.2 | 2.2 | 2.0 | 3.6 |
| Sample 3 | 120 | 89 | 1.5 | 1.6 | 1.7 | 1.9 | 1.2 | 1.3 | 2.5 | 2.8 |
| Sample 4 | 120 | 524 | 9.4 | 1.8 | 5.8 | 1.1 | 8.7 | 1.7 | 14.0 | 2.7 |
| Sample 5 | 120 | 1578 | 30.0 | 1.9 | 17.8 | 1.1 | 20.8 | 1.3 | 40.6 | 2.6 |
| Sample 6 | 120 | 2837 | 94.9 | 3.3 | 23.3 | 0.8 | 131.2 | 4.6 | 163.7 | 5.8 |
| Sample 7 | 120 | 3632 | 101.6 | 2.8 | 52.9 | 1.5 | 162.4 | 4.5 | 198.7 | 5.5 |
| Sample 8 | 120 | 4489 | 128.1 | 2.9 | 28.4 | 0.6 | 239.4 | 5.3 | 273.0 | 6.1 |
Linearity: A verification study was performed to evaluate the linearity of the Access OV Monitor assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access
6
OV Monitor assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 2.0 - 5,000 U/mL.
Limit of Blank (LoB): The LoB for Access OV Monitor assay is 0.5 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The LoD estimate for the Access OV Monitor assay is 0.7 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The maximum LoQ determined for the Access OV Monitor assay is 2.0 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access OV Monitor assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to OV Monitor assay on the Access Immunoassay System (K023597) 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.