{ "format": "devicerts.device.v1", "cite_as": "BCS® XP System 10459330, Siemens Healthcare Diagnostics Products Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/bcs-r-xp-system-ovob03 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/bcs-r-xp-system-ovob03", "json_url": "https://devicerts.com/devices/bcs-r-xp-system-ovob03.json", "markdown_url": "https://devicerts.com/devices/bcs-r-xp-system-ovob03.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-23", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/bcs-r-xp-system-ovob03", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "BCS® XP System 10459330", "registry_name": "BCS® XP System 10459330", "url": "https://devicerts.com/devices/bcs-r-xp-system-ovob03", "manufacturer": { "name": "Siemens Healthcare Diagnostics Products Ltd", "url": "https://devicerts.com/manufacturers/siemens-healthcare-diagnostics-products-ltd", "country": null, "country_basis": null, "fda_registration_country": "Germany" }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "OVOB03", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00630414945514", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K970431", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GKP", "JPA" ], "emdn": [], "gmdn": [ { "code": "56689", "term": "Coagulation analyser IVD, laboratory" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00630414945514", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-24", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K970431", "number_label": null, "device_udi_di": null, "date": "1997-05-05", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1435-2021", "classification": "Class II", "status": "terminated", "initiated": "2021-03-02", "reason": "Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.", "applies": "shared submission", "via": "K970431" }, { "number": "Z-0825-2016", "classification": "Class II", "status": "terminated", "initiated": "2016-01-14", "reason": "False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.", "applies": "shared submission", "via": "K970431" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "BCS® XP System", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Coagulation analyser IVD, laboratory", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "10459330", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "OVOB03", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00630414945514", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K970431", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "GKP", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Coagulation analyser IVD, laboratory", "code": "56689", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "864.5400", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }