(39 days)
Not Found
No
The summary describes a standard immunoassay for detecting antibodies and does not mention any AI or ML components in the device description or performance studies.
No
The device is an in vitro diagnostic assay intended to aid in the diagnosis of pernicious anemia by detecting intrinsic factor antibody; it does not treat or alleviate the condition.
Yes
The "Intended Use" section explicitly states that the device is "intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia."
No
The device description explicitly states it consists of a reagent pack, calibrators, QCs, substrate, and wash buffer, which are all physical components used with an immunoassay analyzer. This indicates it is a hardware-based in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is "intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia." This is the primary indicator of an IVD.
- Device Description: It describes an assay that analyzes human serum and plasma, which are biological samples tested in vitro (outside the body).
- Intended User/Care Setting: It is designed for use in a "clinical laboratory setting," which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Product codes
LIG
Device Description
The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, 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
Method Comparison: A comparison of 128 serum samples using the Access Intrinsic Factor Ab assay on the Dxl 9000 Access Immunoassay Analyzer and Access 2 Immunoassay System gave the following statistical data using statistical analysis:
Negative: 39
Equivocal: 9
Positive: 80
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A comparison of 128 serum samples using the Access Intrinsic Factor Ab assay on the Dxl 9000 Access Immunoassay Analyzer and Access 2 Immunoassay System gave the following statistical data using statistical analysis:
Negative Agreement: 39 / 39 = 100%
Positive Agreement: 78 / 80 = 97.5%
Total Agreement: (39 + 78 + 7) / 128 = 96.9%
Imprecision: The assay was designed to have within-laboratory imprecision as listed below: CV
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a stylized human services symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The human services symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
May 3, 2024
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240800
Trade/Device Name: Access Intrinsic Factor Ab Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: LIG Dated: March 22, 2024 Received: March 25, 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" (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).
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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, 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 (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,
Paula V. Caposino -5
Paula Caposino, Ph.D. Deputy 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
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Indications for Use
510(k) Number (if known) K240800
Device Name Access Intrinsic Factor Ab
Indications for Use (Describe)
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
| 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 K240800
Date Prepared: Mav 2, 2024
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberq@beckman.com
Alternate Contact:
Kuljeet Kaur Senior Manager, Requlatory Affairs Phone: (952) 465-1914 Email: kkaur@beckman.com
Device Name
Common Name: Access Intrinsic Factor Ab Trade Name: Access Intrinsic Factor Ab Classification Name: Radioassay, vitamin b12 Classification Code: LIG Classification Regulation: 862.1810
Predicate Device
Device Name: Access Intrinsic Factor Ab 510(k) Numbers: K033603
Device Description
The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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Intended Use
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
| Parameter | Access Intrinsic Factor Ab on Access
2 Immunoassay System (Predicate) | Access Intrinsic Factor Ab on
Dxl 9000 Access Immunoassay System |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia | The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia. |
| Technology | Two-step immunoenzymatic assay | Same |
| Format | Chemiluminescent | Same |
| Calibration | Single level calibrator of liquid synthetic matrix with an intrinsic factor antibody concentration of 1.0 AU/mL | Same |
| Sample Type | Serum and plasma | Same |
| Results
Interpretation |