BK251285 · Roche Diagnostics Indianapolis, IN 46250 · MYR · Dec 10, 2025 · Microbiology
Device Facts
Record ID
BK251285
Device Name
Elecsys Syphilis
Applicant
Roche Diagnostics Indianapolis, IN 46250
Product Code
MYR · Microbiology
Decision Date
Dec 10, 2025
Decision
SESE
Regulation
21 CFR 866.3830
Device Class
Class 2
Indications for Use
Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. Elecsys Syphilis is intended to screen individual human donors, including volunteer donors of whole blood, blood components, and source plasma. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay "ECLIA" is intended for use with the cobas pro serology solution equipped with cobas e 801 analytical unit.
Device Story
Elecsys Syphilis is a double antigen sandwich immunoassay using streptavidin microparticles and biotinylated/ruthenium-labeled recombinant TP-specific antigens. Device operates on cobas pro serology solution with cobas e 801 analytical unit. Input: human serum or plasma samples. Process: electrochemiluminescence detection (ECLIA). Output: qualitative result (reactive/non-reactive) based on signal comparison to cutoff value (>= 1.0 COI). Used in clinical laboratory settings by trained personnel. Output assists healthcare providers in screening donors for Treponema pallidum antibodies to ensure safety of blood, blood components, source plasma, and organ/tissue/cell donations.
Clinical Evidence
Clinical study evaluated specificity in 3089 source plasma samples from donors with non-reactive nontreponemal test of record. 67 samples were repeat reactive. Discrepant analysis using three FDA-cleared treponemal immunoassays confirmed 59 positive and 8 negative results. False reactive rate was 0.26% (8/3030). Negative percent agreement to treponemal test was 99.74% (95% CI: 99.48% to 99.87%).
Indicated for qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. Intended for screening individual human donors, including volunteer donors of whole blood, blood components, and source plasma, as well as organ, tissue, and cell donors (living). Not for use on cord blood.
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.
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# Elecsys Syphilis
## 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the addition of the source plasma claim to the Elecsys Syphilis intended use.
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| **Submitter Name** | Roche Diagnostics |
| --- | --- |
| **Address** | 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0457 |
| **Contact** | Kelly Brennan Phone: [REDACTED] Email: kelly.brennan@roche.com Secondary Contact: Reanna Toney Phone: [REDACTED] Email: reanna.toney@roche.com |
| **Date Prepared** | September 15, 2023 |
| **Proprietary Name** | Elecsys Syphilis |
| **Common Name** | Treponema pallidum serological reagents |
| **Classification Name** | Test, Donor, Syphilis |
| **Product Codes, Regulation Numbers** | MYR, 21 CFR 866.3830 |
| **Predicate Devices** | Elecsys Syphilis |
| **Establishment Registration** | Roche Diagnostics GmbH Mannheim, Germany: 9610126 Roche Diagnostics GmbH Penzberg, Germany: 9610529 Roche Diagnostics Indianapolis, IN United States: 1823260. |
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# 1. DEVICE DESCRIPTION
Elecsys Syphilis is a double antigen sandwich immunoassay with streptavidin microparticles, biotinylated recombinant TP-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. Results greater than or equal to 1.0 COI are considered reactive for Treponema pallidum antibody. The test system contains the calibrators intended for use with the system
Elecsys Syphilis working solutions include:
- Streptavidin-coated microparticles
- Reagent 1 (biotinylated TP-specific recombinant antigens)
- Reagent 2 (ruthenium labeled TP-specific recombinant antigens)
Note: The reagent and calibrators are packaged together in the Elecsys Syphilis assay kit, while the associated PreciControl Syphilis and PreciControl Release Syphilis are packaged separately.
# 2. INDICATIONS FOR USE
Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. Elecsys Syphilis is intended to screen individual human donors, including volunteer donors of whole blood, blood components, and source plasma. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.
The electrochemiluminescence immunoassay "ECLIA" is intended for use with the cobas pro serology solution equipped with cobas e 801 analytical unit.
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### 3. TECHNOLOGICAL CHARACTERISTICS
**Table 1: Technical Characteristics Comparison Table between Elecsys Syphilis (Candidate Device) and Elecsys Syphilis (BK230839)**
| Feature | Candidate Device Elecsys Syphilis | Predicate Device Elecsys Syphilis (BK230839) |
| --- | --- | --- |
| Intended Use | Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to *Treponema pallidum* in human serum and plasma. Elecsys Syphilis is intended to screen individual human donors including volunteer donors of whole blood, blood components, and source plasma. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay 'ECLIA' is intended for use with the **cobas pro** serology solution equipped with **cobas e** 801 analytical unit. | Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to *Treponema pallidum* in human serum and plasma. Elecsys Syphilis is intended to screen individual human donors including volunteer donors of whole blood and blood components. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay 'ECLIA' is intended for use with the **cobas pro** serology solution equipped with **cobas e** 801 analytical unit. |
| Assay Method | Double antigen sandwich assay | Same |
| Detection Method | electrochemiluminescence immunoassay 'ECLIA' | Same |
| Applications/Test Time | 18 minutes | Same |
| Instrument Platform | **cobas pro** serology solution | Same |
| Sample Type | Human serum, plasma | Same |
| Sample Anticoagulants | Li-heparin, K_{2}-EDTA, K_{3}-EDTA, CPD and Na-citrate | Same |
| Controls | PreciControl Syphilis PreciControl Release Syphilis | Same |
| Plasmapheresis samples used in studies | Yes | No |
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| Feature | Candidate Device Elecsys Syphilis | Predicate Device Elecsys Syphilis (BK230839) |
| --- | --- | --- |
| Source plasma specificity | A total of 3089 source plasma samples from donors with a non reactive nontreponemal (lipoidal antigen) test of record were collected and tested using the Elecsys Syphilis assay. All initial reactive samples were repeat reactive; therefore, the initial negative percent agreement to the non reactive nontreponemal (lipoidal antigen) test of record for the source plasma specimens was 97.83 % (3022/3089). Repeatedly reactive specimens were further tested using treponemal Syphilis immunoassays. Based on supplemental test results, 59 specimens were positive and 8 specimens were negative for anti treponemal antibodies. The false reactive rate in source plasma donors was estimated in this study to be 0.26 % (8/3030). | NA |
#### 4. EXTERNAL (CLINICAL) TESTING
#### 4.1. Clinical Specificity
A total of 3089 source plasma samples from donors with a non-reactive nontreponemal (lipoidal antigen) test of record were collected and tested using the Elecsys Syphilis assay. All initial reactive samples were repeat reactive; therefore, the initial negative percent agreement to the non-reactive nontreponemal (lipoidal antigen) test of record for the source plasma specimens was calculated to be 97.83% (3022/3089) with a 95% confidence interval of 97.25% to 98.29%. The 67 repeatedly reactive specimens were further tested using treponemal Syphilis immunoassays. Two FDA-cleared treponemal Syphilis immunoassays were used to evaluate the cobas® Elecsys Syphilis repeat reactive specimens. Resolution of discrepant results obtained between these two assays were resolved using a third FDA-cleared treponemal Syphilis immunoassay. The final result was derived from the majority results obtained (i.e., two out of three test results). The results obtained are shown in Table 2 below.
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Table 2: Agreement of the cobas® Elecsys Syphilis assay with the additional treponemal Syphilis testing.
| | Final Results | | | |
| --- | --- | --- | --- | --- |
| | | Reactive (R) | | NR |
| Elecsys Syphilis | Repeat Reactive | 59 | 8 | 67 |
| | Non-reactive (NR) | 0 | 3022 | 3022 |
| | Total | 59 | 3030 | 3089 |
Based on additional test results, 59 specimens were positive, and 8 specimens were negative for anti-treponemal antibodies. The false reactive rate in source plasma donors was estimated in this study to be 0.26% (8/3030). Therefore, the negative percent agreement to the treponemal test for the source plasma specimen was calculated to be 99.74% (3022/3030) with a 95% confidence interval of 99.48% to 99.87%.
## 5. CONCLUSIONS
As the cobas® Elecsys Syphilis assay reagents were not changed, additional analytical studies were not performed. As the intended use population was extended to include source plasma donors, an additional clinical study was performed to evaluate the specificity of the device with source plasma specimens. The results demonstrated that the cobas® Elecsys Syphilis device is as safe, as effective, and performs as well as the predicate device.
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