Atlas FDA

LSR

112 FDA 510(k) clearances · Product code

133 daysmedian time to decision
363 days90th percentile
112clearances measured

FDA profile

Official device name
Reagent, Borrelia Serological Reagent
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3830
Medical specialty
Microbiology
Adverse events (MAUDE)
2014: 53 · 2015: 25 · 2016: 10 · 2019: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Sofia Lyme FIA; Sofia 2 Campylobacter FIA (K254295)Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)2026-07-10
Lyme-ID IgG Test; Bio-ID800 (K252627)Inanovate, Inc.2025-11-14
iDart Lyme IgM ImmunoBlot Kit (K242872)Id-Fish Technology, Inc.2025-06-12
iDart Lyme IgG ImmunoBlot Kit (K233367)Id-Fish Technology, Inc.2024-08-12
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit (K230863)Zeus Scientific2023-07-13
Viramed Borrela All-In-One ViraChip Test Kit (K220016)Viramed Biotech AG2022-08-19
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K203295)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K203296)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (K203289)Gold Standard Diagnostics2021-03-22
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573)DiaSorin, Inc.2021-02-18
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (K202574)DiaSorin, Inc.2021-02-18
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023)Gold Standard Diagnostics2020-04-06
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K200025)Gold Standard Diagnostics2020-04-06
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set (K193051)DiaSorin, Inc.2020-01-29
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System (K190907)Zeus Scientific, Inc.2019-07-29
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System (K191398)Zeus Scientific, Inc.2019-07-29
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (K191240)Zeus Scientific, Inc.2019-07-29
BioPlex 2200 Lyme Total (K183446)Bio-Rad Laboratories2019-03-12
Sofia 2 Lyme FIA, Sofia Lyme Control Set (K173496)Quidel Corporation2018-08-30
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K180264)Gold Standard Diagnostics2018-05-02
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (K173691)Quidel Corporation2018-02-28
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (K172722)Euroimmun Us, Inc.2017-12-10
Lyme B. burgdorferi (IgM) MarStripe Test (K172254)Trinity Biotech2017-10-23
Sofia Lyme FIA, Sofia Lyme Control Set (K163713)Quidel Corporation2017-10-20
Borrelia B31 ViraChip IgM Test Kit (K163695)Viramed Biotech AG2017-08-22
Borrelia B31 ViraChip IgG Test Kit (K163504)Viramed Biotech AG2017-07-12
Lyme B. burgdorferi (IgG) MarStripe Test (K163095)Trinity Biotech2017-02-01
Anti-Borrelia burgdorferi US Westernblot (IgG) (K161513)Euroimmun US2016-08-25
EUROIMMUN LYME ELISA(IgG/IgM) (K142038)Euroimmun US2015-05-04
VIDAS LYME IGM (K122979)Biomerieux S.A.2013-06-04
VIDAS LYME IGG (K122986)Biomerieux S.A.2013-03-05
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (K113397)Zeus Scientific, Inc.2012-07-26
BORRELIA BURGDORFERI IGM BLOT TEST (K113846)Gold Standard Diagnostics2012-06-01
BORRELIA BURGDORFERI IGG BLOT TEST (K113847)Gold Standard Diagnostics2012-04-11
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM (K100728)Zeus Scientific, Inc.2010-07-06
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS (K092693)Viramed Biotech AG2009-11-25
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE (K082329)Viramed Biotech AG2009-08-05
PLATELIA LYME IGM (K081362)Bio-Rad2008-06-26
PLATELIA LYME IGG ASSAY (K080012)Bio-Rad2008-05-08
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 (K062473)DiaSorin, Inc.2007-04-12
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (K051071)Viramed Biotech AG2005-08-11
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT (K051169)Viramed Biotech AG2005-08-11
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K033070)Trinity Biotech USA2003-11-26
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K033083)Trinity Biotech USA2003-11-26
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (K032713)Boston Biomedica, Inc.2003-11-24
IMMUNETICS C6 LYME ELISA KIT (K003754)Immunetics, Inc.2001-05-10
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT (K994004)Inova Diagnostics, Inc.2000-01-27
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 (K991062)Immunetics, Inc.1999-09-21
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 (K991063)Immunetics, Inc.1999-09-21
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM (K991185)Zeus Scientific, Inc.1999-09-03
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM (K991180)Zeus Scientific, Inc.1999-09-03
QUANTA LITE LYME IGG ELISA (K984222)Inova Diagnostics, Inc.1999-04-15
QUANTA LITE LYME IGM ELISA (K984234)Inova Diagnostics, Inc.1999-04-15
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM (K984138)Zeus Scientific, Inc.1999-03-23
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT (K980351)Boston Biomedica, Inc.1999-03-05
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (K981913)Chembio Diagnostic Systems, Inc.1999-02-12
IS BORRELIA BURGDORFERI IGM TEST SYSTEM (K983606)Columbia Bioscience, Inc.1998-12-16
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K983605)Columbia Bioscience, Inc.1998-12-16
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) (K971007)Mrl Diagnostics1998-06-01
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) (K971006)Mrl Diagnostics1998-06-01
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) (K970761)Cambridge Diagnostics Ireland, Ltd.1998-04-09
HUMAN LYME IGM WESTERN BLOT KIT (K970768)Cambridge Diagnostics Ireland, Ltd.1998-04-09
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) (K971169)Cambridge Biotech Corp.1998-02-17
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) (K971170)Cambridge Biotech Corp.1998-02-17
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (K974810)Boston Biomedica, Inc.1998-02-05
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (K974809)Boston Biomedica, Inc.1998-02-05
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K965131)Wampole Laboratories1997-03-26
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K965129)Wampole Laboratories1997-03-26
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM (K951709)Mardx Diagnostics, Inc.1996-06-07
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM (K950829)Mardx Diagnostics, Inc.1996-06-05
IMMUNO DOT BORRELIA DOT BLOT G TEST (K953682)Genbio1996-05-03
MMUNO DOT BORRELIA DOT BLOT M TEST (K953683)Genbio1996-05-03
VIDAS LYME SCREEN II (K943812)Biomerieux Vitek, Inc.1995-06-13
BARTELS LYME DISEASE IGM EIA (K922578)Baxter Diagnostics, Inc.1992-09-02
IMMUNODOT BORRELIA (LYME) TEST (K911627)General Biometrics, Inc.1992-04-08
IMMUNOWELL LYME (P39 RECOMBINANT) TEST (K911599)General Biometrics, Inc.1991-12-30
IMMUNOWELL BORRELIA (LYME)TEST (K911590)General Biometrics, Inc.1991-12-20
LYME-CHECK(TM) TEST KIT (K896378)Diagnostic Technology, Inc.1991-11-05
LYME STAT M TEST KIT (K904652)Whittaker Bioproducts, Inc.1991-10-21
FIAX LYME M TEST KIT (K904893)Whittaker Bioproducts, Inc.1991-10-16
LYME-SPOT IF KIT (K910230)Vitek Systems, Inc.1991-08-30
LYME DISEASE IGM ELISA (K900206)Hillcrest Biologicals1991-06-28
FASTTECH SYSTEM 1 (K911496)3M Diagnostic Systems, Inc.1991-06-24
LYME IGM ELISA TEST (K903013)Gull Laboratories, Inc.1991-06-21
LYME IGM MICROASSAY (K911330)Diamedix Corp.1991-06-10
LYME DISEASE MICROASSAY (K910899)Diamedix Corp.1991-06-10
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST (K911145)Medical Diagnostic Technologies, Inc.1991-05-10
3M IGG FASTLYME(TM) TEST (K895713)3M Company1990-12-14
LYME IGM MICROASSAY (K900572)Diamedix Corp.1990-05-02
LYME IGM ELISA TEST SYSTEM (K900196)Zeus Scientific, Inc.1990-05-02
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE (K901054)Bion Ent., Ltd.1990-04-05
LYME IGG ELISA TEST SYSTEM (K895292)Zeus Scientific, Inc.1989-12-13
IMMUNODOT LYME TEST (K894410)General Biometrics, Inc.1989-10-30
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM (K894609)Mardx, Inc.1989-09-19
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM (K894293)Mardx Diagnostics, Inc.1989-08-21
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM (K894224)Mardx Diagnostics, Inc.1989-08-21
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (K892206)Mardx Diagnostics, Inc.1989-08-15
LYME DISEASE MICROASSAY (K890843)Diamedix Corp.1989-07-25
MARDX LYME DISEASE IGG IFA TEST SYSTEM (K890053)Mardx Diagnostics, Inc.1989-04-18
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Every clearance here is in the API, with alerts when new ones post.