ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC

K080869 · Beckman Coulter, Inc. · LGD · May 23, 2008 · Microbiology

Device Facts

• Record ID: K080869
• Device Name: ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
• Applicant: Beckman Coulter, Inc.
• Product Code: LGD · Microbiology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

The Access Toxo IgG assay is a paramagnetic-perticle, 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 and may be used to assess the immune status of pregnant women. This product is not FDA cleared/approved for the screening of blood of plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens of infants.

Device Story

Device is an automated chemiluminescent immunoassay for detecting IgG antibodies to Toxoplasma gondii in human serum. Input: human serum sample. Operation: sample added to reaction vessel with paramagnetic particles coated with T. gondii membrane antigen; specific antibodies bind to antigen; unbound materials washed away via magnetic field; alkaline phosphatase-conjugated anti-human IgG added; second wash removes unbound conjugate; chemiluminescent substrate (Lumi-Phos 530) added; light output measured by luminometer. Output: quantitative/qualitative IgG concentration. Used in clinical laboratories on Beckman Coulter Access Immunoassay Systems. Healthcare providers use results to diagnose infection or assess immune status in pregnant patients. Benefits: aids in clinical management of T. gondii infection.

Clinical Evidence

Clinical performance evaluated via method comparison against Abbott AxSYM Toxo IgG assay across three sites (n=1427 total). Studies included prospective and retrospective collections from prenatal and diagnostic populations. Positive agreement ranged from 80.0% to 99.4%; negative agreement ranged from 94.7% to 100%. Additional validation performed using the 100-member CDC Toxoplasma 1998 Human Serum Panel, showing 100% sensitivity and specificity.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Analyzers: Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600, UniCel Dxl 800. Quantitative/qualitative detection of IgG antibodies. Standardized against WHO International Standard for Anti-Toxoplasma Serum. Analytical sensitivity (LoQ) 3.2 IU/mL.

Indications for Use

Indicated for qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum to aid in diagnosis of infection and assessment of immune status in pregnant women. Not for blood/plasma donor screening. Performance not established for immunocompromised/immunosuppressed patients, cord blood, neonates, or infants.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma 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.

Predicate Devices

• Access Toxo IgG Assay, Calibrators, QC (K951495, K032162)
• AxSYM Toxo IgG Antibody Assay (K954575)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Contact: David M. Ikeda

Date Prepared: May 22, 2008

#### Device Names

| Proprietary Name: | Access Toxo IgG Assay, Access Toxo IgG Calibrators, Access Toxo<br>IgG QC |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | <i>Toxoplasma gondii</i> serological reagents |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, <i>Toxoplasma Gondii</i> |

#### 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<br>(IU/mL) | Observed Dose<br>(IU/mL) | Mean Observed<br>Dose (IU/mL) | Recovery |
| 6.0 | 5.8<br>6.0 | 5.9 | 98.3% |
| 30.0 | 26.6<br>25.2 | 25.9 | 86.3% |
| 60.0 | 65.4<br>64.8 | 65.1 | 108.5% |
| 120.0 | 117.0<br>114.4 | 115.7 | 96.4% |
| 240.0 | 183.6<br>191.1 | 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 Reactive<br>in 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/Heterophilic<br>Antibody | 20 | 2 |
| Mumps IgG | 65 | 2 |
| Influenza (vaccine<br>recipients) | 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 | | | |
|--------|----|-------------------------|------------------------|------------------------|--------------|-------------------------|------------------------|------------------------|--------------|--|--|
| | | Mean<br>Dose<br>(IU/mL) | Intra-<br>assay<br>%CV | Inter-<br>assay<br>%CV | Total<br>%CV | Mean<br>Dose<br>(IU/mL) | Intra-<br>assay<br>%CV | Inter-<br>assay<br>%CV | Total<br>%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 | | Positive<br>Agreement<br>(%) | 95% Conf.<br>Int. | Negative<br>Agreement<br>(%) | 95% Conf.<br>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 | | Positive<br>Agreement<br>(%) | 95% Conf.<br>Int. | Negative<br>Agreement<br>(%) | 95% Conf.<br>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 [phone] or [phone] 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)

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|-------------------|--|

Office of In Vitro Diagnostic Device Evaluation and Safety

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| 510(k) | k 080869 |