Atlas FDA

Alinity i Rubella IgG

FDA 510(k) clearance K243168 · decided 2025-06-20

Clearance details

K-number
K243168
Device name
Alinity i Rubella IgG
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2024-09-30
Decision date
2025-06-20
Days to decision
263 days
Clearance type
Traditional
Product code
LFX
Device class
2
Regulation number
866.3510
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
Access Rubella IgG (K250588)Beckman Coulter, Inc.2025-11-17
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397)DiaSorin, Inc.2012-09-06
MAGO 4S (K093101)Diamedix Corp.2011-01-21
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587)Bio-Rad Laboratories2010-12-03
ELECSYS RUBELLA IGM IMMUNOASSAY (K092322)Roche Diagnostics2010-03-12
VIDAS RUB IGG (K080766)bioMerieux, Inc.2008-12-23
ELECSYS RUBELLA IGG IMMUNOASSAY (K072617)Roche Diagnostics Corp.2008-12-05
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (K073390)DiaSorin, Inc.2008-11-21
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (K063186)Zeus Scientific, Inc.2007-03-21
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143)Ortho-Clinical Diagnostics, Inc.2006-12-26
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606)Beckman Coulter, Inc.2003-06-20
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 (K012077)Diagnostic Products Corp.2002-01-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30