(260 days)
Not Found
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay used to aid in the diagnosis of an infection, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is to be used as an aid in the diagnosis of acute or recent Toxoplasma gondii infection in suspected individuals."
No
The device is an immunoassay kit used on an automated system (Alinity i system) and includes physical reagents (Microparticles and Conjugate), Calibrator, and Controls. This indicates it is a hardware-dependent device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, serum separator, and plasma tubes... on the Alinity i system." This involves testing human specimens in vitro (outside the body) to provide information for diagnosis.
- Indications for Use: It is used "as an aid in the diagnosis of acute or recent Toxoplasma gondii infection in suspected individuals." This directly links the test results to providing diagnostic information.
- Device Description: The description details an "automated, two-step immunoassay for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology." This describes a laboratory test performed on biological samples.
- Performance Studies: The document includes extensive performance studies (Assay Cutoff, Precision, Analytical Specificity, Cross-Reactivity, Matrix Equivalency, Class Specificity, CDC Panel Agreement, Expected Values, Reproducibility, Clinical Agreement) which are typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a predicate device (bioMérieux VIDAS TOXO IgM assay, K923166) is a strong indicator that this device is being compared to an already cleared IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alinity i Toxo IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.
The Alinity i Toxo IgM assay is to be used as an aid in the diagnosis of acute or recent Toxoplasma gondii infection in suspected individuals including women of child-bearing age. It is recommended that the assay be performed in conjunction with a Toxoplasma gondii IgG assay.
The Alinity i Toxo IgM assay has not been cleared for use in screening blood, plasma, or tissue donors.
Product codes (comma separated list FDA assigned to the subject device)
LGD
Device Description
The Alinity i Toxo IgM assay is an automated, two-step immunoassay for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.
Pre-diluted sample and anti-human IgM murine monoclonal antibody coated paramagnetic microparticles are combined and incubated. Together with IgM antibodies of other specificities, anti-Toxo specific IgM present in the sample binds to the anti-human IgM murine monoclonal antibody coated microparticles, forming an antibody-antibody complex. The mixture is washed. A conjugate complex consisting of an acridinium-labeled anti-Toxo p30 antigen murine monoclonal F(ab')2 fragment and native Toxoplasma gondii lysate, containing the p30 antigen, is added to create a reaction mixture and incubated. This conjugate complex is bound by anti-Toxo specific IgM that has been captured by the anti-human IgM murine monoclonal antibody coated microparticles, forming an antibody-antibody-conjugate complex. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.
The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-Toxo IgM in the sample and the RLU detected by the system optics.
The presence or absence of anti-Toxo IgM in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active 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
Prescription Use (Part 21 CFR 801 Subpart D)
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
A clinical method comparison study was conducted to evaluate the clinical performance of the Alinity i Toxo IgM assay based on guidance from CLSI EP12-A2, 2nd ed. * , to evaluate the percent agreement between the Alinity i Toxo IgM investigational assay and a current FDA-cleared, commercially available anti-Toxo IgM assay with specimens collected from 2 populations. Population 1 was comprised of 897 consecutively collected remnant specimens sent to a laboratory for anti-Toxo IgM testing including specimens collected in the US (n = 169) and outside of the US (n = 710), and Population 2 was comprised of 207 consecutively collected remnant specimens from pregnant women sent to a laboratory for anti-Toxo IgM testing in the US.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assay Cutoff
The cutoff for the Alinity i Toxo IgM assay was established using samples characterized with a commercially available anti-Toxo IgM assay. A total of 1219 samples (1053 anti-Toxo IgM nonreactive samples and 166 anti-Toxo IgM reactive samples) were included. A receiver-operating characteristic analysis showed a clear separation of the nonreactive and reactive results using a cutoff of 1.00 S/CO (with a grayzone from 0.83 to
§ 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).
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August 30, 2024
Abbott Laboratories Laura Fraczek Regulatory Affairs Senior Specialist 100 Abbott Park Rd. Abbott Park, Illinois 60064
Re: K233932
Trade/Device Name: Alinity i Toxo IgM Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma Gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: December 13, 2023 Received: December 14, 2023
Dear Laura Fraczek:
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 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-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).
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature indicates that the document was digitally signed by JORGE L. MUNOZ -S. The date of the signature is August 30, 2024. The timestamp of the signature is 10:42:40 -04'00'.
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) K233932
Device Name Alinity i Toxo IgM
Indications for Use (Describe)
The Alinity i Toxo IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum separator, and plasma tubes (Ithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.
The Alinity i Toxo IgM assay is to be used as an aid in the diagnosis of acute or recent Toxoplasma gondii infection in suspected individuals including women of child-bearing age. It is recommended that the assay be performed in conjunction with a Toxoplasma gondii IgG assay.
The Alinity i Toxo IgM assay has not been cleared for use in screening blood, plasma, or tissue donors.
| 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 the 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. 510(k) Number
II. Applicant Name
Abbott Laboratories Department 09AA 100 Abbott Park Road Abbott Park, IL 60064
Primary contact person for all communications:
Laura Fraczek, Senior Specialist Regulatory Affairs Abbott Diagnostics Division Telephone Number: (224) 668-8852 Fax Number: (224) 667-5810
Secondary contact person for all communications:
Jacob Richards, Associate Director, Regulatory Affairs Abbott Diagnostic Division Telephone Number: (224) 668-5877 Fax Number: (224) 667-5810
Date summary prepared: August 28, 2024
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III. Device Name
Alinity i Toxo IgM
Reagents
Trade Name: Alinity i Toxo IgM Reagent Kit Device Classification: Class II Classification Name: Toxoplasma gondii serological reagents Governing Regulation: 21 CFR 866.3780 Code: LGD
Calibrator
Trade Name: Alinity i Toxo IgM Calibrator Device Classification: Class II Classification Name: Toxoplasma gondii serological reagents Governing Regulation: 21 CFR 866.3780 Code: LGD
Controls
Trade Name: Alinity i Toxo IgM Controls Device Classification: Class II Classification Name: Toxoplasma gondii serological reagents Governing Regulation: 21 CFR 866. 3780 Code: LGD
IV. Predicate Device
bioMérieux VIDAS TOXO IgM assay (K923166)
V. Description of Device
Reagents
The kit configurations of the Alinity i Toxo IgM Reagent Kit are described below.
| List Number (LN) | 07P4740 | 07P4745 |
|---|---|---|
| Tests per cartridge | 100 | 500 |
| Number of cartridges per kit | 2 | 2 |
| Tests per kit | 200 | 1000 |
| Microparticles | 6.6 mL | 27.0 mL |
| Conjugate | 6.1 mL | 26.5 mL |
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- Microparticles: Anti-human IgM (murine, monoclonal) antibody coated microparticles in TRIS buffer with protein (bovine and goat) stabilizers, and detergent. Minimum concentration: 0.08 % solids. Preservatives: antimicrobial agents.
- Conjugate: Conjugate complex consisting of acridinium-labeled anti-Toxoplasma ● p30 antigen antibody (murine, monoclonal) and native Toxoplasma gondii lysate in phosphate buffer with protein (bovine) stabilizer, and detergent. Minimum concentration: 25 µg/mL. Preservative: sodium azide.
Calibrator
The Alinity i Toxo IgM Calibrator is described below.
- Calibrator 1: Contains anti-Toxoplasma p30 antigen IgM antibody (human, • monoclonal) prepared in recalcified human plasma. The calibrator is reactive for IgM antibodies to Toxoplasma gondii (anti-Toxo IgM). Preservatives: ProClin 950 and sodium azide.
| Calibrator | Quantity |
|---|---|
| Calibrator 1 | 1 x 3.0 mL |
The Alinity i Toxo IgM Calibrator is manufactured and referenced to an internal reference standard.
Controls
The Alinity i Toxo IgM Controls are described below.
- Negative Control: Contains recalcified human plasma. •
- Positive Control: Contains anti-Toxoplasma p30 antigen IgM antibody (human, . monoclonal) prepared in recalcified human plasma. The positive control is reactive for IgM antibodies to Toxoplasma gondii (anti-Toxo IgM).
- Preservatives: ProClin 950 and sodium azide. •
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| Anti-Toxo IgM | |||
|---|---|---|---|
| Control | Quantity | Target | |
| (S/CO) | Range | ||
| (S/CO) | |||
| Negative Control | 1 x 4.0 mL | - | Toxoplasma gondii lysate |
| • Anti-human IgM murine monoclonal | |||
| antibody | • Immunocomplex of T. gondii antigen (RH Sabin | ||
| strain) | |||
| • Mouse monoclonal anti-P30 antibodies | |||
| Type of Specimen | Serum and Plasma | Serum | |
| Methodology | Chemiluminescent microparticle immunoassay | Enzyme-linked fluorescent immunoassay | |
| Interpretation of | |||
| Results | Nonreactive: Toxoplasma gondii lysate in phosphate | ||
| buffer with protein (bovine) stabilizer, and | |||
| detergent. Minimum concentration: 25 µg/mL. | |||
| Preservative: sodium azide. | Solid Phase Receptacle (SPR) – SPR coated goat | ||
| anti-μ chain antibodies | |||
| Reagent Strip – Strip consists of 10 wells covered | |||
| with labeled, foil seal. The wells contain the various | |||
| reagents required for the assay including: | |||
| • Sample diluent: 300 µL of TRIS buffered saline | |||
| (0.05 mol/L, pH 7.4) with protein and chemical | |||
| stabilizers and 1 g/L sodium azide. | |||
| • Pre-wash: 600 µL of TRIS buffered saline | |||
| (0.05 mol/L, pH 7.4) with protein and chemical | |||
| stabilizers and 1 g/L sodium azide. | |||
| • Wash buffer: 600 µL of TRIS buffered saline | |||
| (0.05 mol/L, pH 7.4) with protein and chemical | |||
| stabilizers and 1 g/L sodium azide. | |||
| • Conjugate: 400 µL of immunocomplex of | |||
| T. gondii antigen (RH Sabin strain) grown in mice | |||
| (9) and mouse monoclonal anti-P30 antibodies | |||
| Subject Device | |||
| Alinity i Toxo IgM | |||
| K233932 | Predicate Device | ||
| VIDAS TOXO IgM Assay | |||
| K923166 | |||
| Characteristics | conjugated to alkaline phosphatase with | ||
| gentamycin 0.02% and 0.9 g/L sodium azide. | |||
| • Reading cuvette with substrate: 4-Methyl- | |||
| umbelliferyl phosphate (0.6 mmol/L) + | |||
| diethanolamine (DEA) (0.62 mol/L or 6.6%, | |||
| pH 9.2) + 1 g/L sodium azide (300 µL). | |||
| Calibration Storage | Maximum of 30 days | 14 days |
Assay Similarities
10
Assay Differences
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VIII. Summary of Nonclinical Performance
A. Assav Cutoff
The cutoff for the Alinity i Toxo IgM assay was established using samples characterized with a commercially available anti-Toxo IgM assay. A total of 1219 samples (1053 anti-Toxo IgM nonreactive samples and 166 anti-Toxo IgM reactive samples) were included. A receiver-operating characteristic analysis showed a clear separation of the nonreactive and reactive results using a cutoff of 1.00 S/CO (with a grayzone from 0.83 to * Clinical and Laboratory Standards Institute (CLSI). Evaluation of Quantitative Measurement Procedures: Approved Guideline-Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.
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C. Analytical Specificity
Potentially Interfering Endogenous Substances
The Alinity i Toxo IgM assay was evaluated for potential interference caused by endogenous substances based on guidance from CLSI EP07, 3rd ed. * and CLSI EP37, 1st ed. * Each substance was evaluated using samples containing anti-Toxo IgM at the target ranges of 0.60 to 0.99 S/CO and 1.00 to 2.00 S/CO.
No significant interference (interference ≤ +0.10 S/CO for samples * Clinical and Laboratory Standards Institute (CLSI). Supplemental Tables for Interference Testing in Clinical Chemistry. 1st ed. CLSI supplement EP37. Wayne, PA: CLSI; 2018.
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| No Significant Interference | |
|---|---|
| Potentially Interfering Other Condition | Interferent Level |
| HAMA | 800 ng/mL |
| RF | 200 IU/mL |
Potentially Interfering Drugs and Other Substances
The Alinity i Toxo IgM assay was evaluated for potential interference caused by exogenous substances based on guidance from CLSI EP07, 3rd ed. and CLSI EP37, 1 st ed. Each substance was evaluated using samples containing anti-Toxo IgM at the target ranges of 0.60 to 0.99 S/CO and 1.00 to 2.00 S/CO.
No significant interference (interference ≤ +0.10 S/CO for samples * Clinical and Laboratory Standards Institute (CLSI). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition. CLSI Document EP12-A2. Wayne, PA: CLSI; 2008.
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| Specimen
Category | Alinity i Toxo IgM
Result | Comparator Result | | | Positive %
Agreement
(95% CI)a | Negative %
Agreement
(95% CI)a |
|--------------------------|------------------------------|-------------------|----|-----|--------------------------------------|----------------------------------------|
| Population 1
(n=897) | Reactive | 150 | 16 | 11 | 94.94
(150/158)
(90.33, 97.41) | 94.44
(697/738)
(92.55, 95.88) |
| | Grayzone/Equivocal | 1 | 1 | 14 | | |
| | Nonreactive | 6 | 1 | 697 | | |
| | Total | 157 | 18 | 722 | | |
| Specimen
Category | Alinity i Toxo IgM
Result | Comparator Result | | | Positive %
Agreement
(95% CI)a | Negative %
Agreement
(95% CI)a |
| Population 2b
(n=234) | Reactive | 18 | 0 | 0 | 94.74
(18/19)
(75.36, 99.06) | 100.00
(215/215)
(98.24, 100.00) |
| | Grayzone/Equivocal | 0 | 0 | 0 | | |
| | Nonreactive | 1 | 0 | 215 | | |
| | Total | 19 | 0 | 215 | | |
PPA and NPA between the Alinity i Toxo IgM assay and an FDA-cleared assay was calculated for each population separately and are shown in the tables below.
a The 95% CI for PPA and NPA were estimated using the Wilson score method.
b Twenty-seven specimens from Population 1 were from pregnant females and therefore, were also included in Population 2.
X. Conclusion Drawn from Nonclinical and Clinical Laboratory Studies
The results presented in this 510(k) premarket notification demonstrate that the subject device (Alinity i Toxo IgM) performance is substantially equivalent to the predicate assay (bioMérieux VIDAS TOXO IgM assay, K923166).