Atlas FDA

ARCHITECT iGentamicin

FDA 510(k) clearance K243500 · decided 2025-07-09

Clearance details

K-number
K243500
Device name
ARCHITECT iGentamicin
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2024-11-12
Decision date
2025-07-09
Days to decision
239 days
Clearance type
Special
Product code
LCD
Device class
2
Regulation number
862.3450
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, 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
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699)Abbott Laboratories2011-04-01
MULTIGENT GENTAMICIN (K060709)Seradyn, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479)Ortho-Clinical Diagnostics, Inc.2005-01-06
ROCHE ONLINE GENTAMICIN (K020704)Roche Diagnostics Corp.2002-07-12
RANDOX GENTAMICIN (K012978)Randox Laboratories, Ltd.2001-09-18
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (K012311)Diagnostic Products Corp.2001-08-20
EMIT 2000 GENTAMICIN PLUS ASSAY (K010984)Syva Co., Dade Behring, Inc.2001-04-20
GENTAMICIN FLEX REAGENT CARTRIDGE (K962819)Dade Intl., Inc.1996-09-13
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519)Behring Diagnostics, Inc.1996-09-04
ACS GENTAMICIN (K953020)Ciba Corning Diagnostics Corp.1995-08-02
IL TEST GENTAMICIN CALIBRATORS (K943982)Instrumentation Laboratory CO1995-01-25
AXSYM GENTAMICIN (K935376)Abbott Mfg., Inc.1994-06-21

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