Atlas FDA

Elecsys AFP

FDA 510(k) clearance K220176 · decided 2022-09-15

Clearance details

K-number
K220176
Device name
Elecsys AFP
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2022-01-21
Decision date
2022-09-15
Days to decision
237 days
Clearance type
Traditional
Product code
LOJ
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VITROS AFP (K213626)Ortho Clinical Diagnostics2022-06-15
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236)Siemens Healthcare Diagnostics2009-04-27
OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709)Olympus Life Science Research Europa GmbH (Europa)2009-03-16
VIDAS AFP ASSAY (K080017)bioMerieux, Inc.2008-09-26
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597)Dade Behring, Inc.2008-06-04
ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894)Tosoh Medics, Inc.2002-12-17
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138)Diagnostic Systems Laboratories, Inc.1999-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031)Ortho-Clinical Diagnostics, Inc.1998-12-18
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263)Diagnostic Products Corp.1998-12-07
ELECSYS AFP (K981282)Roche Diagnostics GmbH1998-05-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01