# Elecsys Syphilis, Elecsys Anti-CMV, cobas pro serology solution (BK241132) _Roche Diagnostics Indianapolis, IN · Nov 6, 2024 · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/BK241132 ## Device Facts - **Applicant:** Roche Diagnostics Indianapolis, IN - **Decision Date:** Nov 6, 2024 - **Decision:** SESE ## 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. 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 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. ## Device Story System automates electrochemiluminescence immunoassay (ECLIA) processing for donor screening; utilizes cobas pro serology controller and cobas e 801 analytical units. Inputs: human serum/plasma samples. Processing: automated test execution, result interpretation, and data management. Outputs: qualitative antibody detection results. Used in donor screening laboratories and plasma fractionation facilities by trained laboratory technicians. Software update for cobas pro analyzer and serology controller application; no changes to assay reagents or indications for use. ## Clinical Evidence No clinical data provided; submission is a Special 510(k) for software changes to an existing, cleared system. ## Technological Characteristics Automated electrochemiluminescence immunoassay (ECLIA) system. Components: cobas pro serology controller, cobas e 801 analytical units. Software-controlled processing, result interpretation, and data management. No changes to assay reagents. ## Predicate Devices - Elecsys Syphilis ([BK230839](/device/BK230839.md)) - Elecsys Anti-CMV ([BK230840](/device/BK230840.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) #: # 510(k) Summary Prepared on: 2024-10-11 Contact Details 21 CFR 807.92(a)(1) Applicant Name Roche Diagnostics Applicant Address 9115 Hague Rd. Indianapolis IN 46250 United States Applicant Contact Telephone 317-385-2540 Applicant Contact Mr. David Tribbett Applicant Contact Email david.tribbett@roche.com Device Name 21 CFR 807.92(a)(2) Device Trade 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 Regulation Number 21 CFR 866.3830, 21 CFR 866.3175 Product Code(s) MYR, MEZ Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code BK230839 Elecsys Syphilis MYR BK230840 Elecsys Anti-CMV MZE Device Description Summary 21 CFR 807.92(a)(4) This Special 510(k) submission describes the changes in software for the cobas pro Serology Solution. The changes are applicable for the Elecsys Syphilis assay and the Elecsys Anti-CMV assay. A device description for these assays are attached. Additionally, the cobas pro serology solution user guide is attached for a full description of the instrument and software. Intended Use/Indications for Use 21 CFR 807.92(a)(5) 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. The electrochemiluminescence immunoassay "ECLIA" is intended with cobas pro serology solution equipped with the cobas e 801 analytical unit. cobas pro serology solution Page 28 of 31 {1} 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 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. ## Indications for Use Comparison 21 CFR 807.92(a)(5) There are no changes to indications for use. ## Technological Comparison 21 CFR 807.92(a)(6) There are no changes to the assay reagents. New labeling for the assays has been included in this submission. This labeling contained a minor revision related to the use of the release controls. The primary purpose of this submission is due to software changes to the system. The software is being revised for the cobas pro analyzer system and the serology controller software application. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) N/A cobas pro serology solution Page 29 of 31 --- **Source:** [https://fda-staging.innolitics.com/device/BK241132](https://fda-staging.innolitics.com/device/BK241132) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com