cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV
Device Facts
| Record ID | BK251280 |
|---|---|
| Device Name | cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV |
| Applicant | Roche Diagnostics Indianapolis, IN 46250 |
| Decision Date | Oct 9, 2025 |
| Decision | SESE |
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 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. Elecsys Anti-CMV is an in vitro immunoassay for the qualitative detection of antibodies to Cytomegalovirus in human serum and plasma. Elecsys Anti-CMV 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 with cobas pro serology solution equipped with the cobas e 801 analytical unit.
Device Story
System automates electrochemiluminescence immunoassay (ECLIA) processing for blood screening; inputs human serum/plasma samples; performs automated test processing, result interpretation, and data management. Operated by trained laboratory technicians in donor screening/plasma fractionation facilities. Software update (v1.2.2 to v1.2.3) for serology controller resolves issues with missing quality control (QC) results and connection interruptions; ensures invalid batches are correctly identified. Output includes qualitative test results; healthcare providers use results to screen blood/organ/tissue donations for infectious disease markers.
Clinical Evidence
No clinical data; no changes to assay reagents.
Technological Characteristics
Automated immunoassay analyzer; ECLIA detection; throughput 300 tests/hour/module; uses disposable assay cups; sample handling via universal racks; reagent storage 5-10°C; incubation at 37°C; Windows 10/Server 2019 environment; Ethernet (HL7) interface; software-controlled test countdown and automated result calculation.
Indications for Use
Indicated for screening individual human donors (including volunteer whole blood/blood component donors) and organ, tissue, and cell donors (beating heart) for Treponema pallidum antibodies (Syphilis) or Cytomegalovirus (CMV) antibodies. Not for use on cord blood specimens.
Predicate Devices
- Elecsys Syphilis, Elecsys Anti-CMV, cobas® pro Serology Solution (BK241148)
Submission Summary (Full Text)
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# Elecsys Syphilis
Elecsys Anti-CMV
cobas® pro Serology Solution
# 510(k) Summary - BK251280
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| **Submitter Name** | Roche Diagnostics |
| --- | --- |
| **Address** | 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0457 |
| **Contact** | Contact Name: Gloria Nyankima Phone: (b) (6) FAX: (b) (6) Email: gloria.nyankima@roche.com Secondary Contact Name: Reanna Toney Phone: (b) (6) Email: reanna.toney@roche.com |
| **Date Prepared** | Sept 30, 2025 |
| **Proprietary Name** | Elecsys Syphilis, Elecsys Anti-CMV, cobas® pro Serology Solution |
| **Common Name** | Syphilis Assay, CMV assay |
| **Classification Name** | test, donor, syphilis, antigens, treponemal; test, donor, cmv |
| **Product Codes** | MYR, 21 CFR 866.3830; MZE, 21 CFR 866.3175 |
| **Predicate Devices** | BK241148, Elecsys Syphilis, Elecsys Anti-CMV, cobas® pro Serology Solution |
| **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
This Special 510(k) submission describes the software changes for the serology controller from version 1.2.2 to 1.2.3 in the cobas pro Serology Solution. There are no changes to the cobas pro core software, which remains version 02-03. The cobas pro serology solution is a combination of the cobas pro serology controller, cobas pro integrated solutions (cobas e 801 analytical units only) and applicable licensed blood screening assays. The system automates electrochemiluminescence immunoassay test processing, result interpretation, and data management functions for screening of donations of whole blood and blood components using plasma or serum samples. The software changes are applicable for the Elecsys Syphilis assay and the Elecsys Anti-CMV assay. These assays are intended to screen individual human donors, including volunteer donors of whole blood, and blood components. This Special 510(k) does not introduce changes to the intended use and does not propose changes to the reagents used in these two assays.
# 2. INDICATIONS FOR USE
## Syphilis Assay:
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.
## Anti-CMV Assay:
Elecsys Anti-CMV is an in vitro immunoassay for the qualitative detection of antibodies to Cytomegalovirus in human serum and plasma. Elecsys Anti-CMV 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.
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The electrochemiluminescence immunoassay “ECLIA” is intended with cobas pro serology solution equipped with the cobas e 801 analytical unit.
cobas pro serology solution:
The cobas pro serology solution is a combination of the cobas pro serology controller, cobas pro integrated solutions (cobas e 801 analytical units only) and applicable licensed blood screening assays. The system automates electrochemiluminescence immunoassay test processing, result interpretation, and data management functions for screening of donations of whole blood and blood components using plasma or serum samples. The system is intended for use only with licensed blood screening assays in US donor screening laboratories and plasma fractionators. It is intended for use only by personnel who are trained in its operation. The cobas pro serology solution is intended to be used by trained laboratory technicians. Intended customers of the cobas pro serology controller used in combination with cobas pro integrated solutions (cobas e 801 analytical units only) are donor screening and plasma fractionation companies in the United States.
### 3. TECHNOLOGICAL CHARACTERISTICS
The primary purpose of this submission is to submit software changes to the serology controller, a component of the cobas pro serology solution system, which impacts the Elecsys Syphilis and Elecsys Anti-CMV. The software was updated for the serology controller software application from version 1.2.2 to 1.2.3 in order to resolve two issues for tests that require release quality controls (QC): missing calculated QC results, and connection interruption. These two issues were identified with the release QC measurement procedure that could lead to batch results being released when they should have been invalidated. Software verification and validation testing, and related risk analysis, were conducted to evaluate the software update. The cobas pro software remains the same (version 02-03). There are no changes to the assay reagents. No changes were made to the intended use or indications for use for the two assays, and the Instructions for Use was not changed. The manual was updated to indicate changes to the release QC procedure. The following tables provide a technical comparison of the Elecsys Syphilis, the Elecsys Anti-CMV, and the cobas pro Serology Solution to their respective predicate device.
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**Table 1: Similarities and Differences between the Elecsys Syphilis (Candidate Device) and Elecsys Syphilis (BK241148).**
| Comparator | Candidate Device: Elecsys Syphilis | Predicate Device: Elecsys Syphilis (BK241148) |
| --- | --- | --- |
| 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 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 | Same |
| 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, K2EDTA, K3EDTA, CPD, and Na Citrate | Same |
| Controls | PreciControl Syphilis PreciControl Release Syphilis | Same |
| Control usage | Due to possible evaporation effects, not more than 4 quality control procedures per vial should be performed. | Same |
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**Table 2: Similarities and Differences between the Elecsys Anti-CMV (Candidate Device) and Elecsys Anti-CMV (BK241148).**
| Comparator | Candidate Device: Elecsys Anti-CMV | Predicate Device: Elecsys Anti-CMV (BK241148) |
| --- | --- | --- |
| Intended Use | Elecsys Anti-CMV is an in vitro immunoassay for the qualitative detection of antibodies to Cytomegalovirus in human serum and plasma. Elecsys Anti-CMV 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 with cobas pro serology solution equipped with the cobas e 801 analytical unit. | Same |
| Assay Method | Double antigen sandwich principle | Same |
| Detection Method | electrochemiluminescence immunoassay 'ECLIA' | Same |
| Applications/Test Time | 18 minutes | Same |
| Instrument Platform | cobas pro serology solution | Same |
| Sample Type | Serum and plasma | Same |
| Sample Anticoagulants | Li Heparin, K2EDTA, K3EDTA, CPD and Na Citrate | Same |
| Controls | PreciControl CMV IgG PreciControl Release CMV IgG | Same |
| Control usage | Due to possible evaporation effects, not more than 4 quality control procedures per vial should be performed. | Same |
**Table 3: Technical Characteristics Comparison Table between cobas pro serology solution in BK241148 versus the Candidate Device.**
| Comparator | Candidate Device: cobas® pro serology solution | Predicate Device: cobas® pro serology solution (BK241148) |
| --- | --- | --- |
| **BASIC FEATURES** | | |
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| Comparator | Candidate Device: cobas® pro serology solution | Predicate Device: cobas® pro serology solution (BK241148) |
| --- | --- | --- |
| Intended Use | Fully automated immunoassay analyzer intended for the in vitro quantitative/ qualitative determination of analytes in body fluids. | same |
| Measurement principle | ECLIA | same |
| Workflow principle | Batch/random | same |
| Throughput | 300 tests/hour/module | same |
| Analyzer size | Floor model | same |
| Configurations | Modular | same |
| **SAMPLE HANDLING** | | |
| Typical sample volumes | 4-60 μL | same |
| Sample types | Serum, plasma, urine and other water based liquid samples, e.g. CSF | same |
| Sample handling system | Input and transport of samples using universal sample racks, modular sample buffer input, core/transportation unit and STAT port | same |
| Sample capacity onboard | 300 | same |
| Sample identification | Barcode or Rack Position | same |
| Assay cups | disposable | same |
| **REAGENT HANDLING** | | |
| Reagent volume | 6-60 μL | same |
| Reagent container | Plastic bottles closed via snap caps | same |
| Reagent access | Snap caps opened by instrument | same |
| Reagent kits | E packs | same |
| No. of channels | 48 | same |
| On-board storage temperature | 5-10 °C | same |
| On-board evaporation protection | automatically opened & closed | same |
| Reagent bottle/Cassette ID | RFID | same |
| On-board reagent capacity storage | Reagent compartment (rotor) for 48 reagent containers onboard | same |
| System reagents | ProCell, CleanCell, Sys Clean, PreClean, | same |
| System cycle time measuring cell | 24 sec | same |
| Auto rerun | available | same |
| Application information transfer to instrument | Electronic transfer via cobas link | same |
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| Comparator | Candidate Device: cobas® pro serology solution | Predicate Device: cobas® pro serology solution (BK241148) |
| --- | --- | --- |
| **PIPETTING SYSTEM** | | |
| Reagent probes | 2 polished steel probes | same |
| Sample probes | Steel probe with disposable tip | same |
| Probe cleaning | Automatic for reagent probe | same |
| Liquid level detection | Capacitance for sample and reagents | same |
| Clot detection | Yes | same |
| **TEST REACTION CHAMBER** | | |
| Temperature control | Incubation at 37oC | same |
| Timing | 9 min, 18 min and 27 min | same |
| **DETECTION INFORMATION** | | |
| Measuring units/Channels | 2 | same |
| Detection unit | ECL unit with sipper, measuring cell and photomultiplier | same |
| **CALIBRATION AND QUALITY CONTROL** | | |
| Calibrators | single use | same |
| Calibration modes | 2 point recalibration (3,4,5 pt. cal. optional) | same |
| Calibration stability | Up to 12 weeks | same |
| On-board QC | No | same |
| Control storage on instrument | No | same |
| Calibrator/ control value transfer | Via remote transfer | same |
| **INTERFACES** | | |
| Host interface | Ethernet (HL7) | same |
| Printer | Laser | same |
| Display | Touch-screen without physical keyboard and mouse | same |
| **cobas pro SOFTWARE** | | |
| Software Version | cobas pro modular system software Version 02-03 | same |
| Configuration | One PC and one core in combination with several e-modules or c analytical modules | same |
| Units controlled | cobas pro c 503, cobas pro ISE and cobas e 801 | same |
| Operating System | Windows 10 | same |
| PC (Controller Unit) functions | Data input (keyboard, disc), data output (screen, printer) | same |
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| Comparator | Candidate Device: cobas® pro serology solution | Predicate Device: cobas® pro serology solution (BK241148) |
| --- | --- | --- |
| Core unit functions | Real time database, data input and output (via Data Manager communication), control of sample conveyor | same |
| Analytical unit(s) functions | Control of analytic processes (pipetting, incubation, detection) and primary signal processing | same |
| Data storage | Real time database in Core unit (storage of System and Application parameters, Calibration Data, QC Data, Sample results, Alarm history) | same |
| Software-controlled test countdown | Available | same |
| Result calculation | Automated measuring of ECL signal and automated calculation of concentrations via calibration curve | same |
| Flagging of errors | available | same |
| **Serology Controller Software** | | |
| Software Version | Serology Controller version 1.2.3 | Serology Controller version 1.2.2 |
| Capacity | control of up to 20 cobas pro quad lines/40 cobas pro dual lines | same |
| Workstation terminal | workstation terminal to operate up to 4 cobas pro lines | same |
| Analytical units managed | Control of up to 80 analytical modules (either 20 core units with 4x e801 modules each, or 40 core units with 2x e801 modules each) | same |
| Server | Multiple servers, high availability server environment with built-in redundancy | same |
| Operating System | Server: Windows Server 2019 (64-bit) Workstation: Windows 10 Enterprise LTSC (64-bit) | same |
#### 4. NON-CLINICAL PERFORMANCE EVALUATION
No non-clinical testing was performed as there were no changes to the assay reagents.
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## **5. CLINICAL PERFORMANCE EVALUATION**
No clinical testing was performed as there were no changes to the assay reagents.
## **6. CONCLUSIONS**
As the Elecsys Syphilis and Elecsys Anti-CMV assay reagents and intended use population have not changed, additional clinical and non-clinical studies were not performed. Software verification and validation testing and related risk analysis were conducted, and the results demonstrated that the cobas Elecsys Syphilis and the Elecsys Anti-CMV with the updated software version 1.2.3 of cobas pro Serology Solution are as safe, as effective, and perform as well as the predicate devices.
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