TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS

K112343 · Siemens Healthcare Diagnostics, Inc. · LIP · Jan 20, 2012 · Microbiology

Device Facts

• Record ID: K112343
• Device Name: TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: LIP · Microbiology
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostics immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA. lithium or sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis. The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening. ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostics use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The performance of the SYPH quality control material has not been established with any other Syphilis assay.

Device Story

Fully automated, antigen sandwich immunoassay using chemiluminometric technology. Input: human serum or plasma samples. Process: sample mixed with acridinium-ester-labeled T. pallidum recombinant antigens; biotinylated T. pallidum recombinant antigens on streptavidin-coated magnetic latex particles capture antigen-antibody complexes. System detects relative light units (RLUs) proportional to antibody concentration. Output: qualitative result (reactive, nonreactive, equivocal) based on Index Value. Used in clinical laboratories; operated by trained personnel. Results assist clinicians in syphilis diagnosis. Benefits: automated, high-throughput screening for T. pallidum antibodies.

Clinical Evidence

Clinical study across three sites compared ADVIA Centaur Syphilis assay to predicate device using 2,108 samples. Overall negative percent agreement: 99.4% (98.8-99.7% CI); positive percent agreement: 97.9% (96.6-98.8% CI). In expected positive population (n=561), positive percent agreement was 99.4% (98.4-99.9% CI). Additional testing included cross-reactivity (265 specimens) and interference studies showing no significant impact from endogenous substances up to tested levels.

Technological Characteristics

Fully automated chemiluminometric immunoassay. Reagents: acridinium-ester-labeled T. pallidum recombinant antigens (TpN17, TpN15) and biotinylated T. pallidum recombinant antigens on streptavidin-coated magnetic latex particles. System: ADVIA Centaur/Centaur XP. Qualitative measurement via RLU detection. Liquid-stable reagents, calibrators, and controls.

Indications for Use

Indicated for qualitative detection of Treponema pallidum antibodies in human serum or plasma (EDTA, lithium/sodium heparin, citrate) to aid syphilis diagnosis. Not for blood/tissue donor screening. Used on ADVIA Centaur and ADVIA Centaur XP systems.

Regulatory Classification

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Predicate Devices

• Immulite 2000 Syphilis Screen (K091361)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness for the

## ADVIA® Centaur Syphilis Assay

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.

A. 510(k) Number:

B. Date of Preparation: November 1, 2011

## C. Proprietarv and Established Names:

ADVIA® Centaur Syphilis Assay ADVIA® Centaur Syphilis Quality Control Materials

## D. Applicant:

Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Kira Gordon, Sr. Regulatory Affairs Specialist Office: [phone] Fax: [phone]

## E. Regulatory Information:

ADVIA® Centaur Syphilis Assay (reagents and calibrators)

- 1. Regulation section: 21 CFR § 866.3830 Treponema pallidum treponemal test reagents
- 2. Classification: Class II
- 3. Product Code: LIP, enzyme linked immunoabsorption assay, treponema pallidum
- 4. Panel: Microbiology

#### ADVIA® Centaur Syphilis Quality Control Materials

- 1. Regulation section: 21 CFR § 862.1660
Quality control material (assayed and unassayed).

- 2. Classification: Class I-
- 3. Product Code: MJY; Kit, serological, negative control

MJX; Kit, serological, positive control

- 4. Panel: Microbiology
#### F. Predicate Device:

ADVIA® Centaur Syphilis Assay (reagents and calibrators) and ADVIA® Centaur Syphilis Quality Control Materials are substantially equivalent to the IMMULITE 2000 Syphilis Screen Test System cleared under k091361

## G. Device Description:

The ADVIA Centaur syphilis assay is a fully automated, antigen sandwich assay, using direct chemiluminometric technology. The ancillary pack reagent containing acridinium-ester-labeled T. pallidum recombinant antigens is added to the sample.

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These T. pallidum antigens complex with the antibodies in the sample. The solid phase containing biotinylated T. pallidum recombinant antigens preformed to streptavidin-coated magnetic latex particles, is then added to the sample. These particles capture the T. pallidum antigen-antibody complexes. Antibody-antigen complexes will form if Syphilis antibodies are present in the sample. A direct relationship exists between the level of antibodies to T. pallidum present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive, nonreactive, or equivocal is determined according to the Index Value established with the calibrators.

The Syphilis kit contains the following:

- 1 ReadyPack® primary reagent pack containing ADVIA Centaur Syphilis Solid Phase Reagent (20 mL);

- 1 Ancillary pack containing ADVIA Centaur Syphilis Ancillary Reagent (10mL)
- ADVIA Centaur Syphilis Master Curve card
- 2 vials of Syphilis Low Calibrator (2 mL fill volume)
- 2 vials of Syphilis High Calibrator (2 mL fill volume)
- ADVIA Centaur Syphilis Calibrator Assigned Value cards

In addition Syphilis quality control materials (2 vials of negative control and 2 vials of positive control with 7 mL fill volume each) are provided separately.

# H. Intended Use:

The ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostics immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA. lithium or sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis. The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening.

ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostics use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The performance of the SYPH quality control material has not been established with any other Syphilis assay.

# I. Substantial Equivalence Information:

Both the predicate device and ADVIA Centaur Syphilis assay employ prepackaged reagents, calibrators and controls for use on automated test systems. A comparison of the important similarities and differences of these assays is provided in the following table:

| Item | New Device: | Predicate Device: |
|--------------|------------------------------------|-------------------|
| Analyte | antibodies to Treponema pallidum | Same |
| Intended Use | For in vitro diagnostic use in the | Same |

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| | qualitative determination of<br>antibodies to Treponema pallidum | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement | qualitative | Same |
| Assay type | direct sandwich immunoassay based<br>on chemiluminescent technology | Enzyme labeled, one-step<br>chemiluminescent immunoassay |
| Sample type | Serum , Heparinized Plasma, EDTA<br>plasma, citrate plasma | Serum , Heparinized Plasma |
| Instrument to be<br>used | ADVIA Centaur | IMMULITE 2000 |
| Capture/Detection<br>Antigen/Antibody | Reagent: recombinant antigens<br>TpN17 and TpN15 as biotin<br>conjugates<br>Ancillary pack: recombinant<br>antigens TpN17 and TpN15 as<br>acridinium ester conjugates | Beads coated with purified<br>recombinant antigen TpN17 are<br>linked to enzyme conjugated<br>purified recombinant TpN17<br>antigen in the reagent. |
| Cut-Offs | < 0.9 Non-reactive<br>≥ 0.9 to < 1.1 Equivocal<br>> 1.1 Reactive | <0.9 Non-reactive<br>> 0.9 to < 1.1 Indeterminate<br>> 1.1 Reactive |
| Sample Volume | 100 µL | 100 µL |
| Interference | Not affected by hemolysis, icterus or<br>lipemia at test levels | Not affected by hemolysis, icterus<br>or lipemia at test levels |
| Hook Effect | None observed | None observed |
| Use of Calibrators | Yes | Yes |
| Calibrators matrix | Human plasma | Human serum |
| Number of<br>calibrators | two | one |
| Calibrator fill<br>volume | Liquid, 2 mL | Lyophilized, 4 mL |
| Use of controls | Yes | Yes |
| Number of controls | two | two |
| Control matrix | Human plasma | Human serum |
| Control fill volume | Liquid, 7 mL | Lyophilized, 6 mL |

# J. Performance Characteristics

Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, reproducibility, interfering and cross-reactive substances.

## a.Precision

Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. Within run and total imprecision were evaluated by testing 5 serum based samples (serum sample pools), 3 plasma based samples (2 controls. low and high. and one additional plasma pool) and 2 calibrators (low and high). The elevated levels were spiked with syphilis antigen to achieve appropriate concentrations. The samples were assayed in duplicate over the course of 20 days, two runs per day, for a total of 40 runs and 80 replicates.

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| Pool | #<br>Repl. | Mean<br>(Index) | Within Run | | Between<br>Run | | Between<br>Day | | Total | |
|----------------------------------------------|------------|-----------------|------------|------|----------------|------|----------------|------|-------|------|
| | | | SD | CV | SD | CV | SD | CV | SD | CV |
| Calibrator High (plasma)<br>(high positive) | 80 | 8.16 | 0.14 | 1.67 | 0.06 | 0.78 | 0.26 | 3.20 | 0.30 | 3.69 |
| Calibrator Low (plasma)<br>(high negative) | 80 | 0.68 | 0.01 | 1.81 | 0.01 | 0.83 | 0.02 | 2.65 | 0.02 | 3.32 |
| Control Negative (plasma)<br>(low negative) | 80 | 0.11 | 0.00 | NA | 0.00 | NA | 0.00 | NA | 0.01 | NA |
| Control Positive (plasma)<br>(moderate pos.) | 80 | 3.84 | 0.06 | 1.50 | 0.04 | 0.99 | 0.12 | 3.22 | 0.14 | 3.69 |
| Plasma sample (moderate positive) | 80 | 1.99 | 0.03 | 1.44 | 0.02 | 1.05 | 0.06 | 2.93 | 0.07 | 3.43 |
| Serum sample 1 (low negative) | 80 | 0.19 | 0.00 | NA | 0.00 | NA | 0.00 | NA | 0.01 | NA |
| Serum sample 2 (high negative) | 80 | 0.80 | 0.01 | 1.16 | 0.01 | 0.86 | 0.02 | 2.86 | 0.03 | 3.20 |
| Serum sample 3 (low positive) | 80 | 1.28 | 0.02 | 1.31 | 0.01 | 0.93 | 0.04 | 2.79 | 0.04 | 3.22 |
| Serum sample 4 (high positive) | 80 | 6.96 | 0.10 | 1.45 | 0.07 | 0.95 | 0.25 | 3.63 | 0.28 | 4.02 |
| Serum sample 5 (high positive) | 80 | 21.45 | 0.41 | 1.93 | 0.28 | 1.29 | 0.75 | 3.50 | 0.90 | 4.20 |

# b.Reproducibility

The reproducibility study was conducted using two different reagent lots at three external sites. The protocol was run over 10 days, 2 runs per day, and 4 replicates per run for the sample pools, and 8 replicates per run for the negative and positive control materials. Reproducibility data pooled across 3 Sites, data is presented separately for a representative reagent lot.

| | #<br>Repl. | Mean | Within Run | | Between Run | | Between<br>Day | | Total | |
|--------------------------------------------------|------------|-------|------------|-----|-------------|-----|----------------|-----|-------|-----|
| Pool | | | SD | CV | SD | CV | SD | CV | SD | CV |
| Negative Control (plasma)<br>(low negative) | 480 | 0.11 | 0.004 | NA | 0.002 | NA | 0.01 | NA | 0.01 | NA |
| Serum Pool 1 (low negative) | 240 | 0.18 | 0.006 | NA | 0.002 | NA | 0.01 | NA | 0.01 | NA |
| Serum Pool 2 (high negative) | 240 | 0.75 | 0.01 | 1.3 | 0.01 | 1.4 | 0.01 | 1.3 | 0.02 | 2.3 |
| Serum Pool 3 (low positive) | 240 | 1.20 | 0.02 | 1.5 | 0.02 | 1.4 | 0.01 | 1.2 | 0.03 | 2.4 |
| Serum Pool 4 (high positive) | 240 | 6.67 | 0.10 | 1.5 | 0.11 | 1.6 | 0.08 | 1.2 | 0.17 | 2.5 |
| Serum Pool 5 (high positive) | 240 | 20.42 | 0.29 | 1.4 | 0.31 | 1.5 | 0.31 | 1.5 | 0.53 | 2.6 |
| Positive Control (plasma)<br>(moderate positive) | 480 | 3.56 | 0.06 | 1.6 | 0.04 | 1.2 | 0.05 | 1.4 | 0.09 | 2.5 |

# c.Interference

Interference by endogenous substances in the ADVIA Centaur Syphilis assay was evaluated at three syphilis levels (negative, low positive and high positive) using a significance criterion of >10% variance from the control. Each serum pool was spiked with an interferent to the levels indicated in the table below.

| Interferent | Tested concentration (up to) |
|------------------------|------------------------------|
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 40 mg/dL |
| Unconjugated Bilirubin | 40 mg/dL |
| Intralipid | 1000 mg/dL |

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| Cholesterol, Total | 400 mg/dL |
|----------------------|-----------|
| Gamma Globulin | 60 mg/dL |
| Protein, Total (HSA) | 11 g/dL |
| Biotin | 500 ng/mL |

There was no indication of interference up to the levels claimed.

For the Syphilis positive samples all results demonstrated < 10% change in index value, with the exception of gamma globulin at concentrations above 30 mg/dL..

## d.Cross-reactivity

A total of 211 cord blood samples, samples from pregnant women (15), 200, and 31d trimester), samples from hospitalized patients, pediatric samples and transplant samples were tested using the ADVIA Centaur Syphilis assay and the predicate device (predicate device). Each sample was tested in singlicate using one lot of reagent on one system. Predicate device and Centaur Syphilis results were determined reactive, non-reactive or indeterminate/equivocal according to the respective result interpretation.

| | | Number of Reactive results | |
|---------------------|---------------------|----------------------------|------------------|
| Clinical Category | Total Number Tested | Centaur Syphilis | Predicate device |
| Cord Blood | 18 | 1* | 1 |
| 1st Trimester | 24 | 1* | 1 |
| 2nd Trimester | 25 | 0 | 0 |
| 3rd Trimester | 25 | 1* | 1 |
| Pediatric | 48 | 0 | 0 |
| Hospitalized | 51 | 2* | 2 |
| Transplant Patients | | | |
| Heart | 1 | 0 | 0 |
| Kidney | 4 | 0 | 0 |
| Liver | 6 | 0 | 0 |
| Lung | 9 | 0 | 0 |

* - positive on predicate device as well

265 specimens from 20 groups of potential cross-reactant disease states were assayed using the ADVIA Centaur Syphilis assay and the predicate device. These samples had a known activity to the potential cross reactant in each group of specimens which was determined by FDA-cleared methods and provided by the respective vendor. Each sample was tested in singlicate using one lot of reagent. The predicate device and Centaur Syphilis results were determined reactive, non-reactive or indeterminate/equivocal according to the respective result interpretation method.

| | | Number of Reactive<br>results | |
|-----------------------------|------------------------|-------------------------------|---------------------|
| Clinical Category | Total Number<br>Tested | Centaur<br>Syphilis | Predicate<br>device |
| Lyme Disease | 10 | 1* | 1 |
| Anti-Nuclear Antibody (ANA) | 10 | 0 | 0 |
| Rheumatoid Factor | 10 | 0 | 0 |
| HAMA | 10 | 2* | 2 |

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| Hepatitis A Infection (HAV) total | 20 | 10* | 10 |
|------------------------------------|----|-----|----|
| Hepatitis A Infection (HAV) IgM | 5 | 0 | 0 |
| Hepatitis B Infection (HBV) | 10 | 0 | 0 |
| Hepatitis C Infection (HCV) | 10 | 0 | 0 |
| Human Immunodeficiency Virus (HIV) | 11 | 0 | 0 |
| Cytomegalovirus (CMV) IgG | 10 | 0 | 0 |
| Cytomegalovirus (CMV) IgM | 5 | 0 | 0 |
| Epstein-Barr Virus (EBV) IgG | 10 | 0 | 0 |
| Herpes Simplex Virus (HSV) IgG | 10 | 5* | 5 |
| Rubella IgG | 10 | 0 | 0 |
| Rubella IgM | 10 | 0 | 0 |
| Toxoplasma IgG | 10 | 1* | 1 |
| Toxoplasma IgM | 10 | 0 | 0 |
| Varicella Zoster Virus (VZV) IgG | 10 | 2* | 2 |
| Lupus (SLE) | 10 | 0 | 0 |
| Drug users | 20 | 3* | 3 |
| Myeloma patients | 13 | 0 | 1 |
| Flu Vaccine recipients | 26 | 0 | 0 |
| Hyper-IgG | 5 | 0 | 0 |
| Hyper-IgM | 10 | 0 | 0 |

* - positive on predicate device as well.

* - all samples that demonstrated a positive result (with the exception of two HAV-positive samples) were also confirmed positive by other tests (TPPA or RRP), indicating reactivity to Syphilis (T. Pallidum antibodies) rather than cross reactivity.

# K. Clinical evaluation

As part of the clinical study, samples from various patient populations were tested at three clinical trial sites with both the ADVIA Centaur Syphilis assay and the predicate device. Results are summarized in the following tables.

| | Predicate Device | | | |
|----------------------|------------------|---------------|-------------|-------|
| ADVIA Centaur System | Reactive | Indeterminate | Nonreactive | Total |
| Reactive | 700 | 1 | 6 | 707 |
| Equivocal | 1 | 0 | 3 | 4 |
| Nonreactive | 14 | 1 | 1382 | 1397 |
| Total | 715 | 2 | 1391 | 2108 |

# Method Comparison, All Sites pooled

The negative percent agreement was 99.4% (1382/1391) with a 95% confidence interval (CI) of 98.8 to 99.7%.

The positive percent agreement was 97.9% (700/715) with a 95% confidence interval (CI) of 96.6 to 98.8%.

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| Expected<br>Positive<br>Subjects | Reactive | Equivocal | Nonreactive | Total | Positive Percent<br>Agreement |
|----------------------------------|-------------|-----------|-------------|-------|-------------------------------|
| TPPA-<br>Reactive | 271 (98.2%) | 1 (0.4%) | 4 (1.4%) | 276 | 99.6% (271/272) |
| Medically<br>Diagnosed | 264 (92.6%) | 0 (0.0%) | 21 (7.4%) | 285 | 99.2% (264/266) |
| Total | 535 (95.4%) | 1 (0.2%) | 25 (4.5%) | 561 | 99.4% (535/538) |

## Method Comparison, Expected Positive Population

The % positive agreement was 99.4% (535/538) with a 95% confidence interval with a 95% confidence interval (CI) of 98.4 to 99.9%, and the % negative agreement was 100% (23/23) with a 95% confidence interval (CI) of 85.2 to 100.0%.

| | | Method Comparison, Samples Sent for Syphilis Testing | | | | | |
|--|--|------------------------------------------------------|--|--|--|--|--|
|--|--|------------------------------------------------------|--|--|--|--|--|

| ADVIA Centaur System | Predicate device | | | |
|----------------------|------------------|---------------|-------------|-------|
| | Reactive | Indeterminate | Nonreactive | Total |
| Reactive | 160 | 1 | 6 | 167 |
| Equivocal | 0 | 0 | 3 | 3 |
| Nonreactive | 3 | 0 | 568 | 571 |
| Total | 163 | 1 | 577 | 741 |

The % positive agreement was 98.2% (160/163) with a 95% confidence interval (CI) of 94.7 to 99.6%, and the % negative agreement was 98.4% (568/577) with a 95% confidence interval (CI) of 97.1 to 99.3%.

## Conclusion:

Comparative testing of the ADVIA Centaur Syphilis assay is substantially equivalent in principle and performance to the predicate device.

Kira Gordon Regulatory Affairs & Compliance November 1, 2011

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure with three heads, representing the department's focus on health and human well-being.

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc Kira Gordon Senior Regulatory Affairs Specialist 511 Benedict Ave Tarrytown, NY 10591

IJAN 2 6 2012

Re: K112343

Trade/Device Name: ADVIA Centaur Syphilis Assay Regulation Number: 21 CFR § 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP Dated: January 17, 2012 Received: January 18, 2012

Dear Dr. Gordon:

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 101 associated in the enactment date of 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, do needs that have occh 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 class II (Special Controls), 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Heral statutes and regulations administered by other Federal agencies. You must or any I odoral bances and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical device related adverse overlity systems (QS) regulation (21 CFR Part 820). This letter roductions as obtion for arketing your device as described in your Section 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 Parts 801 and 11 you dostre positive as the Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise, productions and 22.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generers, 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,

Sayatmo

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: k112343

Device Name:

# ADVIA® Centaur Syphilis assay

ADVIA® Centaur Syphilis Quality Control Materials

Indications For Use:

# The ADVIA Centaur Syphilis assay:

The ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or the qualitative decemination of sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis.

The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening.

# ADVIA Centaur Syphilis Quality Control Materials:

ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostic use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The momer of the SYPH quality control material has not been established with any other Syphilis assay.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Solyaton

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k112343