(86 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, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) assay designed to detect specific antibodies for diagnostic purposes, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection". This direct mention of diagnosis indicates it is a diagnostic device.
No
The device description clearly states it is a paramagnetic-particle chemiluminescent immunoassay and includes physical components like reagent packs, calibrators, QCs, substrate, and wash buffer, designed for use with an immunoassay analyzer. This indicates it is a hardware-based assay system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma". This involves testing samples taken from the human body in vitro (outside the body).
- Device Description: The description details a "paramagnetic-particle chemiluminescent immunoassay" which is a laboratory test performed on biological samples. It also mentions the use of reagent packs, calibrators, QCs, substrate, and wash buffer, all components of an in vitro diagnostic test.
- Clinical Laboratory Setting: The device is designed for use in a "clinical laboratory setting", which is where IVD tests are typically performed.
- Performance Studies: The document describes performance studies like method comparison, imprecision, and reproducibility, which are standard evaluations for IVD devices to demonstrate their analytical performance.
The core function of the device is to analyze a biological sample (serum and plasma) outside the body to provide information about a person's health status (presence of Toxoplasma gondii-specific IgM antibody), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.
The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.
Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.
Product codes (comma separated list FDA assigned to the subject device)
LGD
Device Description
The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II 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 callorators, Access QCs, along with the UniCel DxI Wash Buffer II are designed for use with the DxI 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
adult
Intended User / Care Setting
DxI 9000 Access Immunoassay Analyzer in a 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 conducted to evaluate the performance of the Access Toxo IgM II assay by testing 152 samples, collected from the intended use population, to establish positive percent agreement between the Access Toxo IgM II assay on the candidate DxI 9000 Immunoassay Analyzer and FDA-cleared Access 2 Immunoassay System. This study was performed at an internal site. PPA = 100% (95% CI 91.43% to 100.00%) and NPA = 100% (95% CI 96.53% to 100.00%).
Imprecision: Within-Laboratory Precision: A study based on CLSI EP05-A319 performed on the DxI 9000 Access Immunoassay Analyzer tested multiple samples (240 runs per sample) in duplicate in 2 runs per day for a minimum of 20 days. Three lots of reagent and calibrator were tested on three analyzers. Overall Precision (%CV): Sample 1 (0.14 S/CO) - 6.8%; Sample 2 (1.03 S/CO) - 5.9%; Sample 3 (5.59 S/CO) - 5.9%; Sample 4 (8.77 S/CO) - 5.7%. All results were within the specification of
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Beckman Coulter Inc. Stefanie K Berg Senior Staff Quality Assurance 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K242095
Trade/Device Name: Access Toxo IgM II Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma Gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: July 17, 2024 Received: July 17, 2024
Dear Stefanie K Berg:
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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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assistance/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).
Image /page/2/Picture/2 description: The image shows a digital signature. The signature is for Jorge L. Munoz. The date of the signature is 2024.10.11, and the time is 12:38:31 -04'00'.
Sincerely, Jorge Munoz, Ph.D. Branch Chief Division of Microbiology 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) K242095
Device Name Access Toxo IgM II
Indications for Use (Describe)
The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.
The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.
Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 K242095
Date Prepared: October 9, 2024
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Berg Stefanie K Senior Staff Quality Assurance Phone: (952)-737-9492 Email: skberg@beckman.com
Alternate Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612)-431-7315 Email: kmoelberg@beckman.com
Device Name
Common Name: enzyme linked immunoabsorbent assay, toxoplasma gondii Trade Name: Access Toxo IgM II Classification Name: Toxoplasma gondii serological reagents. Classification Code: LGD Classification Regulation: 21 CFR 866.3780
Predicate Device Device Name: Access Toxo IgM II 510(k) Numbers: K003259
Device Description
The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II 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 callorators, Access QCs, along with the UniCel DxI Wash Buffer II are designed for use with the DxI 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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Intended Use
The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.
The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.
Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.
| Device &
Predicate
Device(s): | K242095
Candidate Device | K003259
Predicate |
|--------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name | Same | Access Toxo IgM II Assay |
| General Device
Characteristic
Similarities | | |
| Intended
Use/Indications for
Use | Same | The Access Toxo IgM II assay is a paramagnetic-
particle chemiluminescent immunoassay for the
qualitative detection of Toxoplasma gondii-
specific IgM antibody in adult human serum and
plasma using the Access Immunoassay Systems.
The Access Toxo IgM II assay is presumptive for
the diagnosis of acute, recent, or reactivated
Toxoplasma gondii infection in males and
pregnant or non-pregnant females. It is
recommended this assay be performed in
conjunction with a Toxoplasma gondii-specific
IgG antibody assay.
Note: This assay has not been cleared/approved by
the FDA for the screening of blood or plasma
donors in the United States. |
| Analyte | Same | IgM antibody to T. gondii |
| Technology | Same | 2-step (sandwich) chemiluminescence
immunoassay |
| Format | Same | Chemiluminescent |
| Method | Same | Automated |
| Calibration | Same | Utilizes a stored calibration curve |
| Calibration
frequency | Same | 28 days |
Comparison of Technological Characteristics to the Predicate
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| Device &
Predicate
Device(s): | K242095
Candidate Device | K003259
Predicate |
|-------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Same | Serum and plasma |
| Results
Interpretation | S/CO