Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LSR — Predicate Candidate Screening

112 FDA 510(k) clearances under this product code; the 50 most recent screened below.

133 daysmedian FDA review time

363 days90th percentile

112clearances measured

K-number	Device	Applicant	Decided	Review days
K254295	Sofia Lyme FIA; Sofia 2 Campylobacter FIA	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	2026-07-10	191
K252627	Lyme-ID IgG Test; Bio-ID800	Inanovate, Inc.	2025-11-14	86
K242872	iDart Lyme IgM ImmunoBlot Kit	Id-Fish Technology, Inc.	2025-06-12	262
K233367	iDart Lyme IgG ImmunoBlot Kit	Id-Fish Technology, Inc.	2024-08-12	315
K230863	ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS	Zeus Scientific	2023-07-13	106
K220016	Viramed Borrela All-In-One ViraChip Test Kit	Viramed Biotech AG	2022-08-19	226
K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Tes	Gold Standard Diagnostics	2021-03-22	133
K203292	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA	Gold Standard Diagnostics	2021-03-22	133
K203296	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Tes	Gold Standard Diagnostics	2021-03-22	133
K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG	Gold Standard Diagnostics	2021-03-22	133
K202573	LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme	DiaSorin, Inc.	2021-02-18	167
K202574	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme	DiaSorin, Inc.	2021-02-18	167
K200023	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Tes	Gold Standard Diagnostics	2020-04-06	91
K200025	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Tes	Gold Standard Diagnostics	2020-04-06	91
K193051	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibod	DiaSorin, Inc.	2020-01-29	89
K190907	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	112
K191398	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	66
K191240	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	82
K183446	BioPlex 2200 Lyme Total	Bio-Rad Laboratories	2019-03-12	90
K173496	Sofia 2 Lyme FIA, Sofia Lyme Control Set	Quidel Corporation	2018-08-30	290
K180264	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA	Gold Standard Diagnostics	2018-05-02	92
K173691	Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack	Quidel Corporation	2018-02-28	89
K172722	Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)	Euroimmun Us, Inc.	2017-12-10	90
K172254	Lyme B. burgdorferi (IgM) MarStripe Test	Trinity Biotech	2017-10-23	89
K163713	Sofia Lyme FIA, Sofia Lyme Control Set	Quidel Corporation	2017-10-20	294
K163695	Borrelia B31 ViraChip IgM Test Kit	Viramed Biotech AG	2017-08-22	237
K163504	Borrelia B31 ViraChip IgG Test Kit	Viramed Biotech AG	2017-07-12	210
K163095	Lyme B. burgdorferi (IgG) MarStripe Test	Trinity Biotech	2017-02-01	89
K161513	Anti-Borrelia burgdorferi US Westernblot (IgG)	Euroimmun US	2016-08-25	84
K142038	EUROIMMUN LYME ELISA(IgG/IgM)	Euroimmun US	2015-05-04	280
K122979	VIDAS LYME IGM	Biomerieux S.A.	2013-06-04	251
K122986	VIDAS LYME IGG	Biomerieux S.A.	2013-03-05	160
K113397	ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM	Zeus Scientific, Inc.	2012-07-26	252
K113846	BORRELIA BURGDORFERI IGM BLOT TEST	Gold Standard Diagnostics	2012-06-01	155
K113847	BORRELIA BURGDORFERI IGG BLOT TEST	Gold Standard Diagnostics	2012-04-11	104
K100728	ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM	Zeus Scientific, Inc.	2010-07-06	113
K092693	VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSG	Viramed Biotech AG	2009-11-25	84
K082329	VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE	Viramed Biotech AG	2009-08-05	356
K081362	PLATELIA LYME IGM	Bio-Rad	2008-06-26	42
K080012	PLATELIA LYME IGG ASSAY	Bio-Rad	2008-05-08	126
K062473	LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS	DiaSorin, Inc.	2007-04-12	231
K051071	VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT	Viramed Biotech AG	2005-08-11	107
K051169	BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT	Viramed Biotech AG	2005-08-11	104
K033070	BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58
K033083	BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58
K032713	BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG	Boston Biomedica, Inc.	2003-11-24	83
K003754	IMMUNETICS C6 LYME ELISA KIT	Immunetics, Inc.	2001-05-10	156
K994004	QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT	Inova Diagnostics, Inc.	2000-01-27	64
K991062	QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062	Immunetics, Inc.	1999-09-21	174
K991063	QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052	Immunetics, Inc.	1999-09-21	174

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda