(53 days)
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and may be used to assess the immune status of pregnant women.
Note: In the United States, this product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.
The Access Toxo IgG Assay, Toxo IgG Calibrators, Toxo IgG QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600 and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative and qualitative determination of anti- Toxoplasma gondii IgG in human serum.
The Access Toxo IgG Assay is intended for the quantitative and qualitative determination of IgG antibodies to Toxoplasma gondii in human serum. It aids in the diagnosis of Toxoplasma gondii infection and can assess the immune status of pregnant women.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit acceptance criteria. However, performance metrics were evaluated in comparison to a predicate device and a CDC panel. The key performance indicators and results are summarized below:
| Performance Metric | Acceptance Criteria (Implied/Predicate-based) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LoQ) | Not explicitly stated as an acceptance criterion, but low detection limit is desirable. | Mean Limit of Quantitation (LoQ) was 3.2 IU/mL. |
| Dilution Recovery (Linearity) | Recovery close to 100% for WHO standards and high patient samples across dilutions. | WHO Standard Recovery: Ranged from 78.1% to 108.5% across five dilutions of the Third International Standard for Anti-Toxoplasma Serum (TOXM). Linearity with High Patient Samples: Mean recovery was 100%, ranging from 93.8% to 109.1%. |
| Analytical Specificity/Interference | Low cross-reactivity with common interfering substances and other infectious agents. Ideally, no equivocal or reactive results in non-reactive samples. | Out of 311 samples tested for cross-reactivity and interference, 9 samples (2.9%) that were non-reactive by another commercial assay were equivocal or reactive in the Access Toxo IgG Assay. Most categories showed 0 equivocal/reactive results. No significant effect from bilirubin, triolein, albumin, or hemoglobin. |
| Reproducibility (Total %CV) | Consistent results across different sites, calibration methods, and runs. While specific %CV thresholds are not stated as acceptance criteria, industry standards for immunoassays typically define acceptable variability. | Combined Results (Daily Calibration): Average total %CV was 12.6% (ranging from 10.3% to 20.0% across samples A001-A007). Combined Results (Stored Calibration): Average total %CV was 15.3% (ranging from 13.7% to 17.3% across samples A001-A007). |
| Method Agreement (Predicate Comparison) | High positive and negative agreement with the predicate device (Abbott AxSYM Toxo IgG method). | Positive Agreement: Ranged from 80.0% to 99.4% across different sites and sample types. Negative Agreement: Ranged from 94.7% to 100% across different sites and sample types. |
| CDC Toxoplasma 1998 Human Serum Panel | 100% sensitivity and specificity (as demonstrated by predicate devices or general expectations for such panels). | Exhibited 100% sensitivity and 100% specificity with the 100-member CDC Toxoplasma 1998 Human Serum Panel. |
2. Sample Size Used for the Test Set and Data Provenance:
- Analytical Specificity/Interference: 311 samples
- Reproducibility: 9 serum samples, tested over 7 days with 5 replicates per run per day, across 3 sites (total N=35 replicates per sample per site category). Total 105 replicates for combined results.
- Method Comparison (Predicate):
- Site 1: 406 samples (frozen, predominantly prenatal screening, also males/non-pregnant females). Provenance: South-central France.
- Site 2: 28 samples (fresh) and 433 samples (frozen) (prenatal screening, also males/non-pregnant females). Provenance: Northeastern United States.
- Site 3 (Manufacturer's site): 558 prenatal specimens (frozen). Provenance: North-central France.
- CDC Toxoplasma 1998 Human Serum Panel: 100-member panel. Provenance: CDC (United States).
- Data Provenance: The data used for method comparison was from various locations including south-central France, north-central France, and the northeastern United States. Sample types included prenatal screening populations, males, and non-pregnant females. The data included both prospective (fresh) and retrospective (frozen) collections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.
- For the analytical studies (sensitivity, linearity, specificity, reproducibility), the "ground truth" is based on the inherent properties of the samples (e.g., known concentrations of WHO standards, defined interfering substances).
- For the method comparison studies, the "ground truth" was established by the predicate device (Abbott AxSYM Toxo IgG method). As such, no human experts were involved in establishing the ground truth for these comparison studies.
- For the CDC Toxoplasma 1998 Human Serum Panel, the panel itself is a "masked, characterized serum panel." This implies the CDC (a reputable organization) established the true positive/negative status of these samples through their own established methods, which may involve expert consensus or other reference methods, but the specifics are not detailed here.
4. Adjudication Method for the Test Set:
- None specifically described for expert adjudication. The "ground truth" for method comparison was the result from the predicate device. If there were discrepancies between the new device and the predicate, the document does not describe a process of expert adjudication to resolve these. Discrepancies are simply presented as part of the agreement tables.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an automated immunoassay for in vitro diagnostic testing, not an imaging device or a system requiring human interpretation with AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone study. The Access Toxo IgG Assay is an automated immunoassay system. All the performance data (analytical sensitivity, linearity, specificity, reproducibility, and method comparison) represents the performance of the algorithm/device alone, without human interpretation of the assay results during the testing process. Human intervention would be limited to standard laboratory procedures (sample loading, maintenance, result interpretation post-analysis).
7. The Type of Ground Truth Used:
- Predicate device results: For the method comparison studies, the results from the Abbott AxSYM Toxo IgG method served as the comparative ground truth.
- Internationally recognized standards: For dilution recovery/linearity, the Third International Standard for Anti-Toxoplasma Serum (TOXM) from WHO was used.
- Characterized serum panels: The CDC Toxoplasma 1998 Human Serum Panel, a masked and characterized panel, was used to assess sensitivity and specificity.
- Known properties of samples/substances: For analytical sensitivity, specificity, and reproducibility, the ground truth was based on the inherent characteristics of the samples (e.g., low-dose samples, samples with known interferents).
8. The Sample Size for the Training Set:
The document does not provide details on a separate "training set" as it is typically understood in machine learning. This is an immunoassay device, and its development likely involved internal optimization and validation rather than training a machine learning model on a distinct dataset. If any "training" refers to internal development and optimization, the size and nature of such internal datasets are not disclosed. The studies described are primarily for validation and verification.
9. How the Ground Truth for the Training Set Was Established:
- As noted above, the concept of a "training set" as in machine learning is not directly applicable here. The document describes validation studies rather than a training process. Therefore, how the "ground truth for the training set" was established is not provided.
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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.
The assigned 510(k) number is: K080869
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1361 Fax: (952) 368-7610 Contact: David M. Ikeda
Date Prepared: May 22, 2008
Device Names
| Proprietary Name: | Access Toxo IgG Assay, Access Toxo IgG Calibrators, Access ToxoIgG QC |
|---|---|
| Common Name: | Toxoplasma gondii serological reagents |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Predicate Devices
Access Toxo IgG Assay, Calibrators, QC (Part Numbers: 34450, 34455, 34459) Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: K951495, K032162
AxSYM Toxo IgG Antibody Assay Abbott Laboratories, Inc. 100 Abbott Park Road Abbott Park, IL 60064 510(k) Number: K954575
Device Description
The Access Toxo IgG Assay, Toxo IgG Calibrators, Toxo IgG QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600 and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative and qualitative determination of anti- Toxoplasma gondii IgG in human serum.
Intended Use
The Access Toxo IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative and qualitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
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Summary of Analytical Studies
Analytical Sensitivity
The analytical sensitivity of the Access Toxo IgG Assay was estimated by repeat testing of a low does sample following CLSI document, EP17-A. The mean limit of quantitation (LoQ) was 3.2 IU/mL.
Dilution Recovery (Linearity)
Recovery with WHO Standard
Five dilutions of the Third International Standard for Anti-Toxoplasma Serum (TOXM) were tested in duplicate in a single run. The recovery performance is presented in the following table.
| WHO Standard Recovery | |||
|---|---|---|---|
| Expected Dose(IU/mL) | Observed Dose(IU/mL) | Mean ObservedDose (IU/mL) | Recovery |
| 6.0 | 5.86.0 | 5.9 | 98.3% |
| 30.0 | 26.625.2 | 25.9 | 86.3% |
| 60.0 | 65.464.8 | 65.1 | 108.5% |
| 120.0 | 117.0114.4 | 115.7 | 96.4% |
| 240.0 | 183.6191.1 | 187.4 | 78.1% |
WHO Standard Recovery
Linearity with High Patient Samples
Four highly reactive sera were diluted from 1/1.5 to 1/32 in Access Toxo IgG Calibrator, S0. These dilutions were tested in quadruplicate and the results were compared to expected values based on the neat sample determination (eight replicates). The mean recovery for the four sera was 100% and ranged from 93.8% to 109.1%.
Analytical Specificity/Interference
A study was conducted to investigate potential cross-reactivity with immunoglobulins resulting from exposure to other infectious agents that can produce symptoms similar to Toxoplasma infection (CMV, Epstein-Barr virus, HIV, HSV-1, HSV-2, malaria, measles, rubella VZV, mumps and Treponema). In addition, interference due to heterophilic antibodies (HAMA), abnormal immune system conditions (myeloma, rheumatoid factor, ANA) and influenza vaccine was evaluated. A total of 311 samples were tested. Nine samples (2.9%) that were non-reactive by another commercially available assay were equivocal or reactive in the Access Toxo IgG Assay. The observed performance with each condition is presented in the following fable:
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| Condition | Number tested | Equivocal or Reactivein Access Toxo IgG |
|---|---|---|
| ANA | 14 | 0 |
| CMV IgG | 8 | 0 |
| EBV IgG | 13 | 0 |
| HAV Ab | 10 | 0 |
| HBV (HBsAg) | 11 | 0 |
| HCV Ab | 14 | 0 |
| HIV | 43 | 2 |
| HSV-1 IgG | 3 | 0 |
| HSV-2 IgG | 8 | 2 |
| Malaria | 7 | 0 |
| Measles IgG | 13 | 0 |
| Myeloma IgG | 12 | 0 |
| Rheumatoid Factor | 15 | 0 |
| Rubella IgG | 12 | 0 |
| VZV IgG | 11 | 0 |
| HAMA/HeterophilicAntibody | 20 | 2 |
| Mumps IgG | 65 | 2 |
| Influenza (vaccinerecipients) | 23 | 0 |
| Syphilis | 43 | 1 |
The Access Toxo IgG Assay was not significantly affected by the presence of 300 mg/L bilirubin (100 mg/L free + 200 mg/L conjugated), 30 g/L triolein (triglycerides), 90 g/L albumin or 20 g/L hemoglobin.
Reproducibility
Reproducibility/repeatability of the Access Toxo IgG Assay was estimated at one internal (Site 3) and two external sites (Sites 1 and 2). Each site performed one run per day over seven test days. Nine serum samples were run in replicates of five in each run.
| Site 1 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Daily Calibration | Stored Calibration | ||||||||
| Mean | Intra- | Inter- | Total | Mean | Intra- | Inter- | Total | ||
| Dose | assay | assay | %CV | Dose | assay | assay | %CV | ||
| Sample | N | (IU/mL) | %CV | %CV | %CV | (IU/mL) | %CV | %CV | %CV |
| A001 | 35 | 3.18 | 14.2 | 6.3 | 15.5 | 3.44 | 12.2 | 5.5 | 13.4 |
| A002 | 35 | 9.51 | 5.9 | 6.3 | 8.7 | 9.71 | 5.8 | 6.3 | 8.5 |
| A010 | 35 | 12.6 | 5.1 | 8.2 | 9.6 | 12.9 | 5.1 | 2.3 | 5.6 |
| A003 | 35 | 14.9 | 5.4 | 9.6 | 11.0 | 15.3 | 5.6 | 5.6 | 8.0 |
| A004 | 35 | 19.4 | 8.9 | 6.9 | 11.2 | 19.9 | 8.9 | 6.9 | 11.3 |
| A009 | 35 | 44.1 | 4.4 | 6.3 | 7.7 | 46.0 | 4.6 | 2.7 | 5.3 |
| A005 | 35 | 92.7 | 4.9 | 3.5 | 6.1 | 95.6 | 4.7 | 7.1 | 8.5 |
| A006 | 35 | 235.2 | 7.0 | 6.4 | 9.5 | 261.0 | 8.0 | 6.6 | 10.4 |
| A007 | 35 | 271.7 | 7.7 | 5.0 | 9.2 | 304.2 | 8.1 | 8.2 | 11.5 |
Site 1
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| Site | 2 |
|---|---|
| ------ | --- |
| Daily Calibration | Stored Calibration | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | N | Mean Dose (IU/mL) | Intra-assay %CV | Inter-assay %CV | Total %CV | Mean Dose (IU/mL) | Intra-assay %CV | Inter-assay %CV | Total %CV |
| A001 | 35 | 4.15 | 6.0 | 7.8 | 9.8 | 3.78 | 5.8 | 10.5 | 12.0 |
| A002 | 35 | 7.92 | 3.5 | 7.6 | 8.4 | 7.17 | 3.5 | 6.3 | 7.2 |
| A010 | 35 | 11.4 | 5.6 | 5.9 | 8.1 | 10.3 | 5.5 | 2.7 | 6.1 |
| A003 | 35 | 12.2 | 3.4 | 7.3 | 8.0 | 11.1 | 3.4 | 4.7 | 5.9 |
| A004 | 35 | 17.3 | 4.6 | 6.8 | 8.2 | 15.8 | 4.7 | 4.9 | 6.8 |
| A009 | 35 | 39.8 | 4.5 | 2.7 | 5.3 | 36.7 | 4.5 | 4.6 | 6.5 |
| A005 | 35 | 84.0 | 7.5 | 9.0 | 11.7 | 76.2 | 8.0 | 7.4 | 10.9 |
| A006 | 35 | 235.5 | 5.0 | 6.3 | 8.0 | 219.6 | 5.1 | 9.9 | 11.1 |
| A007 | 35 | 266.7 | 4.7 | 4.7 | 6.7 | 250.5 | 5.0 | 8.4 | 9.8 |
Site 3
| Daily Calibration | Stored Calibration | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| MeanDose(IU/mL) | Intra-assay%CV | Inter-assay%CV | Total%CV | MeanDose(IU/mL) | Intra-assay%CV | Inter-assay%CV | Total%CV | ||||
| Sample | N | ||||||||||
| A001 | 35 | 3.78 | 8.0 | 18.6 | 20.3 | 3.98 | 7.3 | 13.5 | 15.4 | ||
| A002 | 35 | 9.22 | 6.6 | 4.5 | 7.9 | 9.30 | 4.3 | 4.9 | 6.5 | ||
| A010 | 35 | 14.1 | 4.5 | 7.0 | 8.4 | 14.0 | 4.4 | 5.7 | 7.2 | ||
| A003 | 35 | 13.7 | 4.7 | 4.9 | 6.8 | 13.7 | 4.5 | 3.4 | 5.7 | ||
| A004 | 35 | 19.4 | 3.7 | 0.8 | 3.8 | 19.1 | 3.6 | 1.6 | 3.9 | ||
| A009 | 35 | 47.4 | 3.2 | 5.3 | 6.2 | 46.2 | 3.3 | 4.3 | 5.4 | ||
| A005 | 35 | 91.6 | 2.9 | 5.5 | 6.2 | 95.0 | 3.4 | 4.2 | 5.4 | ||
| A006 | 35 | 268.7 | 4.9 | 4.5 | 6.6 | 269.4 | 4.5 | 0.0 | 4.3 | ||
| A007 | 35 | 321.8 | 5.3 | 2.7 | 5.9 | 322.7 | 6.2 | 2.4 | 6.7 |
| Combined Results | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Daily Calibration | Stored Calibration | ||||||||||
| Sample | N | Mean Dose (IU/mL) | Intra-assay %CV | Inter-assay %CV | Inter-site %CV* | Total %CV* | Mean Dose (IU/mL) | Intra-assay %CV | Inter-assay %CV | Inter-site %CV* | Total %CV* |
| A001 | 105 | 3.70 | 13.5 | 6.9 | 13.0 | 20.0 | 3.73 | 12.1 | 5.7 | 6.9 | 15.1 |
| A002 | 105 | 8.88 | 7.7 | 2.5 | 9.4 | 12.5 | 8.73 | 6.9 | 2.7 | 15.6 | 17.3 |
| A010 | 105 | 12.7 | 8.1 | 2.4 | 10.5 | 13.5 | 12.4 | 6.3 | 0.3 | 15.2 | 16.4 |
| A003 | 105 | 13.6 | 8.1 | 3.1 | 9.8 | 13.1 | 13.4 | 6.6 | 0.7 | 15.6 | 17.0 |
| A004 | 105 | 18.7 | 7.6 | 3.1 | 6.3 | 10.3 | 18.3 | 7.8 | 1.8 | 11.8 | 14.3 |
| A009 | 105 | 43.8 | 6.1 | 1.6 | 8.6 | 10.7 | 43.0 | 5.4 | 1.1 | 12.6 | 13.7 |
| A005 | 105 | 89.4 | 7.2 | 3.4 | 5.1 | 9.5 | 88.9 | 7.1 | 3.9 | 12.3 | 14.8 |
| A006 | 105 | 246.4 | 7.2 | 3.2 | 7.7 | 11.0 | 250.0 | 7.9 | 3.5 | 10.6 | 13.7 |
| A007 | 105 | 286.7 | 7.0 | 1.3 | 10.6 | 12.7 | 292.5 | 8.8 | 2.9 | 12.8 | 15.8 |
*The inter-site and total estimates also include contributions from inter-lot variation.
The observed average total %CV was 12.6% with daily calibration and 15.3% using a stored calibration curve.
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Summary of Clinical Studies
Method Comparison
Studies comparing the performance of the Access Toxo IgG assay with the Abbott AxSYM Toxo lgG method were conducted at one external site in south-central France (Site 1), one external site in the northeastern United States (Site 2) and at the manufacturer's site (Site 3). The external sites tested samples collected from their own routine prenatal screening population as well as specimens from males and non-pregnant females that had Toxo IgG testing ordered. Two clinical sample suppliers provided the routine Toxo IgG test specimens for the U.S. site. The manufacturer tested prenatal specimens collected at three hospitals in north-central France.
Method agreement results for the prospective (frozen) and retrospective (frozen) collections by test site are presented in the following two tables.
| Comparison EIA | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| + | + | + | EQV | EQV | EQV | - | - | - | ||||
| n | Access | + | EQV | - | + | EQV | - | + | EQV | - | ||
| Site 1 | 406 | Frozen | 154 | 3 | 2 | 3 | 3 | 4 | 0 | 2 | 235 | |
| Site 2 | 28 | Fresh | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 23 | |
| Site 2 | 433 | Frozen | 190 | 2 | 0 | 4 | 6 | 0 | 1 | 0 | 230 | |
| Site 3 | 558 | Frozen | 356 | 2 | 0 | 2 | 0 | 0 | 1 | 1 | 196 |
Retrospective/Prospective Patient Population
| Agreement Table for Retrospective/Prospective Patient Population | ||||||
|---|---|---|---|---|---|---|
| n | PositiveAgreement(%) | 95% Conf.Int. | NegativeAgreement(%) | 95% Conf.Int. | ||
| Site 1 | 406 | Frozen | 94.5 | 89.8 - 97.4 | 97.9 | 95.2 - 99.3 |
| Site 2 | 28 | Fresh | 80.0 | 28.5 - 99.5 | 100 | 85.3 - 100 |
| Site 2 | 433 | Frozen | 99.0 | 96.3 - 99.9 | 97.9 | 95.1 - 99.3 |
| Site 3 | 558 | Frozen | 99.4 | 98.0 - 99.9 | 98.0 | 94.9 - 99.4 |
Agreement Table for Retrospective/Prospective Patient Population
These results are presented for the prenatal and diagnostic populations (male and female) by test site in the next two tables.
| Pregnant/Non-Pregnant Population | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Access | Comparison EIA + | EQV | - | |||||||
| + | EQV | - | + | EQV | - | + | EQV | - | |||
| Site 1 | 229 | Pregnant | 37 | 3 | 0 | 2 | 2 | 2 | 0 | 1 | 182 |
| Site 2 | 173 | Pregnant | 13 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 158 |
| Site 3 | 558 | Pregnant | 356 | 2 | 0 | 2 | 0 | 0 | 1 | 1 | 196 |
| Site 1 | 76 | Female | 47 | 0 | 2 | 1 | 0 | 2 | 0 | 0 | 24 |
| Site 1 | 101 | Male | 70 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 29 |
| Site 2 | 180 | Female | 97 | 2 | 0 | 4 | 6 | 0 | 0 | 0 | 71 |
| Site 2 | 108 | Male | 84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 |
Pregnant/Non-Pregnant Population
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| n | PositiveAgreement(%) | 95% Conf.Int. | NegativeAgreement(%) | 95% Conf.Int. | ||
|---|---|---|---|---|---|---|
| Site 1 | 229 | Pregnant | 88.1 | 74.4 - 96.0 | 98.4 | 95.3 - 99.7 |
| Site 2 | 173 | Pregnant | 92.9 | 66.3 - 99.8 | 99.4 | 96.5 - 100 |
| Site 3 | 558 | Pregnant | 99.4 | 98.0 - 99.9 | 98.0 | 94.9 - 99.4 |
| Site 1 | 76 | Female | 92.2 | 81.1 - 97.8 | 96.0 | 79.7 - 99.9 |
| Site 1 | 101 | Male | 100 | 94.9 - 100 | 96.7 | 82.8 - 99.9 |
| Site 2 | 180 | Female | 98.0 | 92.9 - 99.8 | 94.7 | 86.9 - 98.5 |
| Site 2 | 108 | Male | 100 | 95.7 - 100 | 100 | 85.8 - 100 |
Table 4: Agreement Table for Pregnant/Non-Pregnant Population
CDC Toxoplasma 1998 Human Serum Panel
The Access Toxo IgG Assay exhibited 100% sensitivity and specificity with the 100-member CDC Toxoplasma 1998 Human Serum Panel. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
Conclusion
The Access Toxo IgG Assay, Calibrators and QC (Part numbers: A31588, A31589) on the Access Immunoassay Systems are substantially equivalent to the AxSYM Toxo IgG Assay and the Access Toxo IgG Assay, Calibrators and QC (Part numbers: 34450, 34455, 34459) for the quantitative and qualitative determination of IgG antibodies to Toxoplasma gondii in human serum.
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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three lines representing the branches of government and a wavy line at the bottom.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David M. Ikeda Staff Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
MAY 2 3 2008
Re: K080869
Trade/Device Name: Access® Toxo IgG Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma Gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: March 31, 2008 Received: March 31, 2008
Dear Mr. Ikeda:
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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), v please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080869
| Device Name: | Access Toxo IgG |
|---|---|
| Access Toxo IgG Calibrators | |
| Access Toxo IgG QC |
Indications For Use:
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and may be used to assess the immune status of pregnant women.
Note: In the United States, this product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.
Prescription Use -----------× (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| ------------------- | -- |
Office of In Vitro Diagnostic Device Evaluation and Safety
| Page 1 of | 1 |
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| 510(k) | k 080869 |
§ 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).