# cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV (BK241148) _Roche Diagnostics Indianapolis, IN · Jan 10, 2025 · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/BK241148 ## Device Facts - **Applicant:** Roche Diagnostics Indianapolis, IN - **Decision Date:** Jan 10, 2025 - **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 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, result interpretation, and data management for donor screening; utilizes cobas pro serology controller and cobas e 801 analytical units; operated by trained laboratory technicians in donor screening/plasma fractionation facilities; software updates implemented for cobas pro analyzer and serology controller application; system processes serum/plasma samples to detect syphilis and CMV antibodies; output used by laboratory personnel for donor screening decisions. ## Clinical Evidence No clinical or analytical testing required due to the minor nature of the software changes. ## Technological Characteristics Electrochemiluminescence immunoassay (ECLIA) platform; cobas e 801 analytical unit; software-controlled automated processing; system includes serology controller and integrated analytical units. ## Predicate Devices - Elecsys Syphilis ([BK241132](/device/BK241132.md)) - Elecsys Anti-CMV ([BK241132](/device/BK241132.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: 2024-12-18 # 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,MZE # Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code BK241132 Elecsys Syphilis MYR BK241132 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: 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 cobas pro serology solution Page 27 of 30 {1} 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. ## 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) The changes reported here are minor software changes and no analytical testing nor clinical testing is required. cobas pro serology solution Page 28 of 30 --- **Source:** [https://fda-staging.innolitics.com/device/BK241148](https://fda-staging.innolitics.com/device/BK241148) **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