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 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 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. 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.

AI/ML Overview

The provided 510(k) summary describes the ADVIA® Centaur Syphilis Assay, an in-vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the performance metrics required for substantial equivalence. The document primarily focuses on establishing substantial equivalence through performance characteristics like precision, reproducibility, interference, cross-reactivity, and clinical evaluation (method comparison).

Performance Characteristic	Acceptance Criteria (Implied by Predicate & Equivalence)	Reported Device Performance (ADVIA® Centaur Syphilis Assay)
Precision	CV% values at various concentrations within acceptable limits for a diagnostic immunoassay.	Demonstrated low CV% values across different sample pools and calibrator levels:Calibrator High: Total CV 3.69%Calibrator Low: Total CV 3.32%Control Positive: Total CV 3.69%Plasma sample (mod positive): Total CV 3.43%Serum sample 5 (high positive): Total CV 4.20%
Reproducibility	Consistent results across different sites, lots, and days, with acceptable CV% values.	Demonstrated low CV% values across 3 external sites and 2 reagent lots:Negative Control: Total SD 0.01 (CV not applicable due to low mean)Serum Pool 2 (high negative): Total CV 2.3%Serum Pool 3 (low positive): Total CV 2.4%Serum Pool 5 (high positive): Total CV 2.6%Positive Control: Total CV 2.5%
Interference	No significant interference (e.g., >10% variance) from common endogenous substances at specified concentrations.	No indication of interference up to the tested levels, with the exception of gamma globulin at concentrations above 30 mg/dL for syphilis positive samples exhibiting <10% change.
Cross-reactivity	Minimal cross-reactivity with other common conditions/pathogens, demonstrating specificity for T. pallidum antibodies.	Low rates of "reactive" results in various clinical categories (e.g., cord blood, trimesters, pediatric, hospitalized, transplant patients). Many reactive results (marked with *) were also positive on the predicate device and confirmed by other tests (TPPA or RRP) as reactivity to Syphilis, not cross-reactivity.
Method Comparison (Clinical Evaluation)	High positive and negative percent agreement with the predicate device.	All Sites Pooled:Negative Percent Agreement: 99.4% (1382/1391), 95% CI: 98.8 to 99.7%Positive Percent Agreement: 97.9% (700/715), 95% CI: 96.6 to 98.8%Expected Positive Population:Positive Agreement: 99.4% (535/538), 95% CI: 98.4 to 99.9%Negative Agreement: 100% (23/23), 95% CI: 85.2 to 100.0%Samples Sent for Syphilis Testing:Positive Agreement: 98.2% (160/163), 95% CI: 94.7 to 99.6%Negative Agreement: 98.4% (568/577), 95% CI: 97.1 to 99.3%

2. Sample Size Used for the Test Set and Data Provenance

Precision Test Set: 5 serum-based samples, 3 plasma-based samples (2 controls, 1 plasma pool), and 2 calibrators. Each assayed in duplicate over 20 days (40 runs, 80 replicates). Data provenance not explicitly stated, but likely from laboratory-prepared pools.
Reproducibility Test Set: Sample pools and control materials (negative and positive). Assayed over 10 days, 2 runs/day, 4 replicates/run for pools, 8 replicates/run for controls (Negative Control: 480 replicates total, Positive Control: 480 replicates total, Serum Pools: 240 replicates each total). Data collected from three external sites. Provenance of the samples is not explicitly stated beyond being "serum pools" and "control materials."
Interference Test Set: Three syphilis levels (negative, low positive, high positive) were used as serum pools spiked with interferents. Provenance not explicitly stated.
Cross-reactivity Test Set:
- 211 cord blood samples, 15 samples from pregnant women (1st, 2nd, 3rd trimester), 48 pediatric samples, 51 hospitalized samples, and 20 transplant samples.
- 265 specimens from 20 groups of potential cross-reactant disease states. These were provided by respective vendors and had known activity to the potential cross-reactant (determined by FDA-cleared methods).
- Provenance is mixed; some are specific clinical categories (cord blood, trimester, hospitalized, pediatric, transplant), others are disease-state specific and sourced from vendors. All samples were likely retrospective clinical samples.
Clinical Evaluation (Method Comparison) Test Set:
- All Sites Pooled: 2108 samples.
- Expected Positive Population: 561 samples (TPPA-Reactive and Medically Diagnosed).
- Samples Sent for Syphilis Testing: 741 samples.
- Data collected from three clinical trial sites. The samples are described as "samples from various patient populations." This strongly suggests prospective or retrospective clinical samples collected at these sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Precision, Reproducibility, Interference: These studies do not typically involve human experts for establishing ground truth, as they evaluate the analytical performance of the assay based on known concentrations or characteristics of the samples.
Cross-reactivity: The cross-reactivity samples with known activity to potential cross-reactants had this activity "determined by FDA-cleared methods." For the "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)," these confirmatory tests serve as the ground truth, implying expert interpretation of these results. No specific number or qualifications of experts are mentioned.
Clinical Evaluation (Method Comparison):
- The predicate device results served as the primary comparator.
- For the "Expected Positive Population," ground truth was established by:
  - TPPA-Reactive: This refers to the Treponema pallidum particle agglutination assay, a highly specific confirmatory test for syphilis. The results of this assay would be considered expert-interpreted or based on established laboratory criteria.
  - Medically Diagnosed: This implies a clinical diagnosis made by healthcare professionals (experts) based on various factors, including clinical signs, symptoms, and other laboratory tests.
- No specific number or qualifications of individual experts are detailed.

4. Adjudication Method for the Test Set

For the analytical studies (precision, reproducibility, interference), no adjudication method is relevant.
For cross-reactivity, samples positive on the new device were cross-referenced with the predicate device and "confirmed positive by other tests (TPPA or RRP)." This implies a form of consensus or confirmatory testing rather than direct human adjudication of discordant results between the new device and the predicate.
For the clinical evaluation (method comparison), the comparison is directly between the new device and the predicate device. Discordant results are not mentioned as undergoing a formal adjudication process; instead, the overall agreement rates are presented. The "Expected Positive Population" analysis further validates the device against established external criteria (TPPA and medical diagnosis).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated in-vitro diagnostic immunoassay, meaning its output is quantitative (Index Value) and then categorized as reactive, non-reactive, or equivocal, directly by the instrument based on established cut-offs. There is no human "reader" independently interpreting the primary output of the device itself. Therefore, the concept of improving human reader performance with or without AI assistance is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies presented are essentially standalone performance studies for the device. The ADVIA® Centaur Syphilis Assay is a fully automated immunoassay system. All performance characteristics (precision, reproducibility, interference, cross-reactivity, and method comparison) evaluate the performance of the algorithm/system in determining the presence of T. pallidum antibodies without direct human intervention in the interpretation of each individual test result. The output (reactive, non-reactive, equivocal) is generated solely by the device.

7. The Type of Ground Truth Used

The ground truth for the test sets in the clinical evaluation was primarily established by:

Predicate Device Results: The IMMULITE 2000 Syphilis Screen Test System, a previously cleared device for the same intended use.
Confirmatory Assays: For cross-reactivity and the "Expected Positive Population," confirmed positive results by established tests like TPPA (Treponema pallidum particle agglutination assay) and RPR (Rapid Plasma Reagin) served as ground truth for true syphilis infection/reactivity.
Medical Diagnosis: For the "Expected Positive Population," some cases were identified as "Medically Diagnosed," indicating a clinical ground truth established by healthcare professionals.
Known Activity to Potential Cross-Reactants: For some cross-reactivity samples, the activity was determined by FDA-cleared methods and provided by vendors.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. For in-vitro diagnostic assays, particularly predicate-based submissions, the focus is typically on validation of the final, locked algorithm/reagent formulation rather than iterative training and testing cycles common in AI/ML software development. The "training" phase would have occurred during the development of the assay by the manufacturer, but details are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set was Established

Since no explicit "training set" is mentioned, the method for establishing its ground truth is also not specified. It can be inferred that during the development of the assay, the manufacturer would have used panels of well-characterized samples (positive for syphilis, negative for syphilis, and those with various interfering/cross-reacting conditions) to optimize the assay's antigens, reagents, and cutoff values. The ground truth for these development/training samples would likely have been established using reference methods, confirmatory tests (like TPPA), and clinical diagnosis.

Summary

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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: (914) 524-2996 Fax: (914) 524-2500

E. Regulatory Information:

ADVIA® Centaur Syphilis Assay (reagents and calibrators)

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

ADVIA® Centaur Syphilis Quality Control Materials

1. Regulation section: 21 CFR § 862.1660
  Quality control material (assayed and unassayed).
1. Classification: Class I-
1. Product Code: MJY; Kit, serological, negative control

MJX; Kit, serological, positive control

1. 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:

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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.

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 ofantibodies to Treponema pallidum
Measurement	qualitative	Same
Assay type	direct sandwich immunoassay basedon chemiluminescent technology	Enzyme labeled, one-stepchemiluminescent immunoassay
Sample type	Serum , Heparinized Plasma, EDTAplasma, citrate plasma	Serum , Heparinized Plasma
Instrument to beused	ADVIA Centaur	IMMULITE 2000
Capture/DetectionAntigen/Antibody	Reagent: recombinant antigensTpN17 and TpN15 as biotinconjugatesAncillary pack: recombinantantigens TpN17 and TpN15 asacridinium ester conjugates	Beads coated with purifiedrecombinant antigen TpN17 arelinked to enzyme conjugatedpurified recombinant TpN17antigen in the reagent.
Cut-Offs	< 0.9 Non-reactive≥ 0.9 to < 1.1 Equivocal> 1.1 Reactive	<0.9 Non-reactive> 0.9 to < 1.1 Indeterminate> 1.1 Reactive
Sample Volume	100 µL	100 µL
Interference	Not affected by hemolysis, icterus orlipemia at test levels	Not affected by hemolysis, icterusor lipemia at test levels
Hook Effect	None observed	None observed
Use of Calibrators	Yes	Yes
Calibrators matrix	Human plasma	Human serum
Number ofcalibrators	two	one
Calibrator fillvolume	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	#Repl.	Mean(Index)	Within Run		BetweenRun		BetweenDay		Total
			SD	CV	SD	CV	SD	CV	SD	CV
Calibrator High (plasma)(high positive)	80	8.16	0.14	1.67	0.06	0.78	0.26	3.20	0.30	3.69
Calibrator Low (plasma)(high negative)	80	0.68	0.01	1.81	0.01	0.83	0.02	2.65	0.02	3.32
Control Negative (plasma)(low negative)	80	0.11	0.00	NA	0.00	NA	0.00	NA	0.01	NA
Control Positive (plasma)(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.

	#Repl.	Mean	Within Run		Between Run		BetweenDay		Total
Pool			SD	CV	SD	CV	SD	CV	SD	CV
Negative Control (plasma)(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)(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 Reactiveresults
Clinical Category	Total NumberTested	CentaurSyphilis	Predicatedevice
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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ExpectedPositiveSubjects	Reactive	Equivocal	Nonreactive	Total	Positive PercentAgreement
TPPA-Reactive	271 (98.2%)	1 (0.4%)	4 (1.4%)	276	99.6% (271/272)
MedicallyDiagnosed	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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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)

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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

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
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), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).