(86 days)
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.
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.
The provided text is a 510(k) premarket notification summary for the Access Toxo IgM II assay, a diagnostic immunoassay, not an AI/ML-driven device. Therefore, many of the requested criteria (e.g., sample size for training set, number of experts for ground truth, MRMC study, AI assistance effect size) are not applicable to this type of medical device submission.
However, I can extract and present the relevant information regarding the device's acceptance criteria and the study proving it meets these criteria based on the provided text.
Acceptance Criteria and Device Performance for Access Toxo IgM II Assay
This document describes the validation of the Access Toxo IgM II assay on the DxI 9000 Access Immunoassay Analyzer, demonstrating its substantial equivalence to the previously cleared Access Toxo IgM II assay on the Access 2 Immunoassay System. The primary performance metrics reported are Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Imprecision (CV%).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the results presented, which showed 100% agreement for both positive and negative samples, and the imprecision results were well within the design specification.
| Performance Metric | Acceptance Criteria (Implied/Design Goal) | Reported Device Performance | Study Type |
|---|---|---|---|
| Method Comparison/Accuracy | High agreement with predicate device | Method Comparison | |
| Positive Percent Agreement (PPA) | N/A (demonstrated 100% agreement) | 100% (95% CI: 91.43% to 100.00%) | Method Comparison (Access 2 vs. DxI 9000) |
| Negative Percent Agreement (NPA) | N/A (demonstrated 100% agreement) | 100% (95% CI: 96.53% to 100.00%) | Method Comparison (Access 2 vs. DxI 9000) |
| Imprecision (Within-Laboratory) | ≤ 20.0% CV (Design Goal) | Precision (CLSI EP05-A3) | |
| Sample 1 (Non-Reactive) Overall CV% | ≤ 20.0% | 6.8% | Within-Laboratory Precision |
| Sample 2 (Reactive, Low) Overall CV% | ≤ 20.0% | 5.9% | Within-Laboratory Precision |
| Sample 3 (Reactive, Mid) Overall CV% | ≤ 20.0% | 5.9% | Within-Laboratory Precision |
| Sample 4 (Reactive, High) Overall CV% | ≤ 20.0% | 5.7% | Within-Laboratory Precision |
| Imprecision (Reproducibility) | N/A (Overall CV% for precision) | Reproducibility (CLSI EP05-A3) | |
| Sample 1 (Non-Reactive) Overall CV% | N/A (demonstrated acceptable precision) | 6.8% | Reproducibility |
| Sample 2 (Reactive, Low) Overall CV% | N/A (demonstrated acceptable precision) | 5.3% | Reproducibility |
| Sample 3 (Reactive, Mid) Overall CV% | N/A (demonstrated acceptable precision) | 4.1% | Reproducibility |
| Sample 4 (Reactive, High) Overall CV% | N/A (demonstrated acceptable precision) | 4.6% | Reproducibility |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Study: 152 samples.
- Data Provenance: Samples were "collected from the intended use population." The study was "performed at an internal site." No specific country of origin or whether the data was retrospective or prospective is mentioned, but "intended use population" generally implies clinical samples.
- Imprecision Studies (Within-Laboratory & Reproducibility):
- For each of the 4 samples tested: N = 240 (for within-laboratory precision) and N = 225 (for reproducibility). These represent the number of individual measurements.
- The study involved testing multiple samples in duplicate (for precision) or in replicates of 5 (for reproducibility) over multiple days, across three reagent/calibrator lots and three analyzers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a laboratory diagnostic immunoassay, not an image-based AI/ML device where expert consensus for ground truth is typically required. The "ground truth" for the method comparison study was the result from the FDA-cleared predicate device (Access Toxo IgM II on the Access 2 Immunoassay System).
4. Adjudication Method for the Test Set
N/A. The comparison was directly between the candidate device (DxI 9000) and the predicate device (Access 2). There was no human adjudication process involved in settling discrepancies between results from different analyzers beyond standard laboratory procedures for confirming unexpected results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for an automated immunoassay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies evaluate the standalone performance of the device/assay system (Access Toxo IgM II on the DxI 9000) against a reference standard (predicate device or established precision metrics). The system itself performs the measurement and provides a qualitative (Reactive, Equivocal, Non-Reactive) result. There isn't an "algorithm only" in the AI/ML sense, but the device operates autonomously to produce results.
7. The Type of Ground Truth Used
- Method Comparison: The results obtained from the FDA-cleared predicate device (Access Toxo IgM II on the Access 2 Immunoassay System) served as the reference for determining agreement.
- Imprecision: The consistency of the device's own measurements provided the "ground truth" for precision relative to established statistical methods (CLSI EP05-A3).
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device that requires a distinct "training set." The device is a chemical immunoassay system. The development of such assays involves extensive R&D, reagent formulation, and analytical validation, but not "training data" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
N/A. As stated above, there is no "training set" or corresponding ground truth establishment in the context of an AI/ML model. The assay's analytical performance relies on validated biochemical reactions and instrument calibration.
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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).
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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 &PredicateDevice(s): | K242095Candidate Device | K003259Predicate |
|---|---|---|
| Device TradeName | Same | Access Toxo IgM II Assay |
| General DeviceCharacteristicSimilarities | ||
| IntendedUse/Indications forUse | Same | The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for thequalitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum andplasma using the Access Immunoassay Systems.The Access Toxo IgM II assay is presumptive forthe diagnosis of acute, recent, or reactivatedToxoplasma gondii infection in males andpregnant or non-pregnant females. It isrecommended this assay be performed inconjunction with a Toxoplasma gondii-specificIgG antibody assay.Note: This assay has not been cleared/approved bythe FDA for the screening of blood or plasmadonors in the United States. |
| Analyte | Same | IgM antibody to T. gondii |
| Technology | Same | 2-step (sandwich) chemiluminescenceimmunoassay |
| Format | Same | Chemiluminescent |
| Method | Same | Automated |
| Calibration | Same | Utilizes a stored calibration curve |
| Calibrationfrequency | Same | 28 days |
Comparison of Technological Characteristics to the Predicate
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| Device &PredicateDevice(s): | K242095Candidate Device | K003259Predicate |
|---|---|---|
| Sample Type | Same | Serum and plasma |
| ResultsInterpretation | S/CO < 0.8 Non-Reactive$0.8 \u2264$ S.CO < 1.0 EquivocalS/CO $\u2265$ 1.0 Reactive | S/CO < 1.0 Non-Reactive$0.8 \u2264$ S.CO < 1.0 Grey ZoneS/CO $\u2265$ 1.0 Reactive |
| Capture Antibody | Same | Anti-human IgM antibody (sheep) |
| DetectionAntibody | Same | Inactivated T. gondii Ag - T. gondii (P30)-specificmouse monoclonal antibody conjugated toalkaline phosphatase (bovine) complex |
| Stability | Same | 28 days after opening, 2-10°C |
| General DeviceCharacteristicDifferences | ||
| Substrate | Lumi-Phos PRO substrate | Access Substrate |
| Instrument | DxI 9000 Access ImmunoassayAnalyzer | Access Immunoassay System |
Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline -Third Edition
CLSI EP12-3rd Edition-: Evaluation of Qualitative, Binary Output Examination Performance; Approved Guideline
Summary of Studies
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 and agreement analysis is shown in table below.
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Table 1 Performance Agreement of Access Toxo IgM II Assay on the Access 2 Immunoassay Analyzer to the DxI 9000 System (n=152)
| Access Toxo IgM II | Access 2 Immunoassay Analyzer | ||||
|---|---|---|---|---|---|
| Reactive | Grey Zone | Non-Reactive | |||
| DxI 9000System | Reactive | 41 | 0 | 0 | |
| System | Equivocal | 0 | 4 | 0 | |
| Non-Reactive | 0 | 0 | 107 | ||
| Total | 41 | 4 | 107 | ||
| PositivePercentAgreement(PPA) | $41 / 41 = 100%$ | 95% CIa =91.43% to100.00% | |||
| NegativePercentAgreement(NPA) | $107 / 107 = 100%$ | 95% CIa =96.53% to100.00% |
295% CI for PPA and NPA were estimated using the Wilson score method.
Imprecision:
The assay was designed to have within-laboratory imprecision of ≤ 20.0% CV.
Within-Laboratory Precision: A study based on CLSI EP05-A319 performed on the DxI 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days. Three lots of reagent and calibrator were tested on three analyzers for the study (one lot per instrument). Analysis was performed combining the imprecision studies for the three lots to estimate the contribution of instrument, reagent lot and calibrator lot factors. While the contribution of instrument, reagent lot, and calibrator lot variability is confounded across the three studies, a single between-lot & instrument vas estimated to represent the contribution of all three sources of variability. The combined results for all three lots are presented below.
| Sample | N | Mean(S/CO) | Repeatability(Within-Run) | Between-Run | Between-Day | Between Lot&Instrumenta | OverallPrecisionb | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Sample 1 | 240 | 0.14 | 0.004 | 2.8% | 0.005 | 3.6% | 0.003 | 1.9% | 0.006 | 4.7% | 0.009 | 6.8% |
| Sample 2 | 240 | 1.03 | 0.040 | 3.9% | 0.024 | 2.3% | 0.010 | 0.9% | 0.038 | 3.7% | 0.061 | 5.9% |
| Sample 3 | 240 | 5.59 | 0.151 | 2.7% | 0.083 | 1.5% | 0.160 | 2.9% | 0.230 | 4.1% | 0.329 | 5.9% |
| Sample 4 | 240 | 8.77 | 0.207 | 2.4% | 0.169 | 1.9% | 0.213 | 2.4% | 0.368 | 4.2% | 0.502 | 5.7% |
ª Access Toxo IgM II reagent lot, Access Toxo IgM II calibrator lot are confounded, and the confounding effect is represented by between-lot.
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b Overall within-laboratory variability includes within-run, between-day, and between-lot variance components.
A reproducibility study based on CLSI EP05-A3'' performed on the DxI 9000 Access Immunoassay Analyzer tested
multiple samples in replicates of 5 in 1 run per day for a minimu were tested on three analyzers for the study. The combined results for all three lots are presented below.
| Sample | N | Mean(S/CO) | Repeatability(Within-Run) | Between-Daya | Between-Instrument | Between- ReagentLot | Reproducibilityb | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample 1 | 225 | 0.14 | 0.004 | 3.2% | 0.005 | 4.0% | 0.004 | 2.8% | 0.005 | 3.5% | 0.009 | 6.8% |
| Sample 2 | 225 | 1.10 | 0.034 | 3.1% | 0.044 | 4.0% | 0.008 | 0.7% | 0.015 | 1.4% | 0.058 | 5.3% |
| Sample 3 | 225 | 4.83 | 0.117 | 2.4% | 0.154 | 3.2% | 0.000 | 0.0% | 0.047 | 1.0% | 0.199 | 4.1% |
| Sample 4 | 225 | 9.26 | 0.210 | 2.3% | 0.316 | 3.4% | 0.081 | 0.9% | 0.170 | 1.8% | 0.424 | 4.6% |
ª Days and runs are confounded
b Reproducibility includes within-run, between-instrument, and between-lot variance components.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Toxo IgM II assay on the DxI 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Toxo IgM II assay on the Access 2 Immunoassay System as demonstrated through the information and data provided in this submission.
§ 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).