LFX · Class II · 21 CFR 866.3510

FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

Leading manufacturers include Abbott Laboratories, Ortho Diagnostic Systems, Inc. and Diamedix Corp..

94
Total
94
Cleared
172d
Avg days
1979
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 263d recently vs 170d historically

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Rubella Devices (Product Code LFX)

94 devices
1–24 of 94
Cleared Nov 17, 2025
Access Rubella IgG
K250588
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168
Abbott Laboratories
Microbiology · 263d
Cleared Sep 06, 2012
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397
DiaSorin, Inc.
Microbiology · 30d
Cleared Jan 21, 2011
MAGO 4S
K093101
Diamedix Corp.
Microbiology · 477d
Cleared Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
K092587
Bio-Rad Laboratories
Microbiology · 466d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322
Roche Diagnostics
Microbiology · 220d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766
bioMerieux, Inc.
Microbiology · 280d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390
DiaSorin, Inc.
Microbiology · 354d
Cleared Mar 21, 2007
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186
Zeus Scientific, Inc.
Microbiology · 152d
Cleared Dec 26, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
K063143
Ortho-Clinical Diagnostics, Inc.
Microbiology · 71d
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606
Beckman Coulter, Inc.
Microbiology · 29d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077
Diagnostic Products Corp.
Microbiology · 192d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668
Bayer Corp.
Microbiology · 121d
Cleared Apr 13, 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412
Bayer Corp.
Microbiology · 162d
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875
Diamedix Corp.
Microbiology · 62d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291
DiaSorin, Inc.
Microbiology · 132d
Cleared Jul 20, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180
Zeus Scientific, Inc.
Microbiology · 239d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983805
Zeus Scientific, Inc.
Microbiology · 210d
Cleared Jan 28, 1999
IS-RUBELLA IGG TEST SYSTEM
K981729
Diamedix Corp.
Microbiology · 258d
Cleared Dec 11, 1998
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
K982078
Diagnostic Products Corp.
Microbiology · 179d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304
Inova Diagnostics, Inc.
Microbiology · 269d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613
Diagnostic Products Corp.
Microbiology · 204d
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 554d

About Product Code LFX - Regulatory Context

510(k) Submission Activity

94 total 510(k) submissions under product code LFX since 1979, with 94 receiving FDA clearance (average review time: 172 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LFX Product Code

Recent submissions under LFX have taken an average of 263 days to reach a decision - up from 170 days historically. Manufacturers should account for longer review timelines in current project planning.

LFX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →