Atlas FDA

JZO

92 FDA 510(k) clearances · Product code

78 daysmedian time to decision
188 days90th percentile
92clearances measured

FDA profile

Official device name
System, Test, Thyroid Autoantibody
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5870
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 19 · 2022: 25 · 2023: 33 · 2024: 29 · 2025: 44 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ADVIA Centaur Anti-Thyroid Peroxidase II (K250250)Siemens Healthcare Diagnostics, Inc.2025-10-17
Access TPO Antibody (K240469)Beckman Coulter, Inc.2024-08-09
Access Thyroglobulin Antibody II (K213517)Beckman Coulter, Inc.2023-09-26
Elecsys Anti-Tg (K222610)Roche Diagnostics2023-09-15
Elecsys Anti-TSHR (K193313)Roche Diagnostics2020-02-27
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (K151799)Phadia AB2016-03-25
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (K152061)Siemens Healthcare Diagnostics, Inc.2016-03-03
THYRETAIN TM TSI REPORTER BIOASSAY (K092229)Diagnostic Hybrids, Inc.2010-05-18
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 (K090760)Theratest Laboratories, Inc.2009-09-03
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (K083391)Diagnostic Hybrids, Inc.2009-05-21
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB (K080092)Roche Diagnostics Corp.2008-07-28
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (K080159)Kronus Market Development Associates, Inc.2008-05-22
FIDIS TM THYRO, MODEL MX002 (K061794)Biomedical Diagnostics (Bmd) SA2006-11-21
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (K052407)Fisher Diagnostics2006-07-18
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 (K061382)Beckman Coulter, Inc.2006-07-06
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM (K052308)Fisher Diagnostics2006-05-10
ROCHE ELECSYS ANTI-TG (K053426)Roche Diagnostics Corp.2006-02-07
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (K051890)Roche Diagnostics Corp.2005-08-04
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM (K033977)Zeus Scientific, Inc.2004-03-22
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN (K033454)Brahms Diagnostica, LLC2004-03-22
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT (K032134)Kronus Market Development Associates, Inc.2003-09-10
SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (K023593)Quest Intl., Inc.2003-02-06
ELECSYS ANTI-TG TEST SYSTEM (K020672)Roche Diagnostics Corp.2002-08-05
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 (K020687)Axis-Shield Diagnostics, Ltd.2002-05-02
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS (K020349)Axis-Shield Diagnostics, Ltd.2002-05-02
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS (K020348)Axis-Shield Diagnostics, Ltd.2002-05-02
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS (K012777)Bayer Corp.2001-10-22
TPO IGG ANTIBODY EIA TEST (K011082)Scimedx Corp.2001-06-06
ALPCO MILENIA ANTI-TG EIA (K011415)American Laboratory Products Co., Ltd.2001-05-30
ALPCO MILENIA ANTI-TPO ELISA (K011201)American Laboratory Products Co., Ltd.2001-05-24
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY (K003291)Bayer Diagnostics Corp.2000-12-05
VARELISA TG (THYROGLOBULIN) ANTIBODIES, (K003414)Pharmacia & Upjohn Co.2000-11-27
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM (K000155)Roche Diagnostics Corp.2000-05-17
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO (K000287)Brahms Diagnostica, LLC2000-03-17
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG (K000286)Brahms Diagnostica, LLC2000-03-17
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM (K000362)Zeus Scientific, Inc.2000-02-18
VARELISA TPO ANTIBODIES, MODEL 12348/12396 (K993585)Pharmacia & Upjohn Co.2000-01-05
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO (K992791)Brahms Diagnostica, LLC1999-11-12
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG (K992790)Brahms Diagnostica, LLC1999-11-12
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 (K991094)Diagnostic Products Corp.1999-05-13
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 (K991096)Diagnostic Products Corp.1999-05-13
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT (K984165)The Binding Site, Ltd.1999-02-02
ANTI-TPO EIA DIAGNOSTIC TEST KIT (K984163)The Binding Site, Ltd.1999-02-02
IS ANTI-TPO IGG ELISA TEST SYSTEM (K984228)Columbia Bioscience, Inc.1999-02-02
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY (K983992)Nichols Institute Diagnostics1999-01-26
ANTI-TG IGG ELISA TEST SYSTEM (K983553)Columbia Bioscience, Inc.1998-12-07
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 (K982866)Nichols Institute Diagnostics1998-10-16
AIA-PACK TPOAB ASSAY (K981521)Tosoh Medics, Inc.1998-10-08
AIA-PACK TGAB ASSAY (K981522)Tosoh Medics, Inc.1998-10-08
UNICAP THYROID PEROXIDASE IGG (K981930)Pharmacia & Upjohn Co.1998-07-07
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY (K981559)Pharmacia & Upjohn Co.1998-07-07
IMMULITE ANTI-TG AB (K980206)Diagnostic Products Corp.1998-05-01
THYROGLOBULIN ASSAY SYSTEM (K972190)American Laboratory Products Co., Ltd.1997-07-14
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ (K963695)Diagnostic Products Corp.1997-01-17
THYROGLOBULIN ANTIBODY ELISA (K960370)Immco Diagnostics, Inc.1996-06-20
THYROID PEROXIDASE ANTIBODY ELISA (K960369)Immco Diagnostics, Inc.1996-06-20
DIASTAT ANTI-THYROID PEROXIDASE KIT (K951487)Shield Diagnostics, Ltd.1995-06-30
DIASTAT ANTI-THYROGLOBULIN KIT (K952183)Shield Diagnostics, Ltd.1995-06-30
ORGENTEC ANTI-TG ELISA (K952130)American Laboratory Products Co., Ltd.1995-06-20
ORGENTEC ANTI-TPO ELISA (K952129)American Laboratory Products Co., Ltd.1995-06-20
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) (K950217)American Laboratory Products Co., Ltd.1995-04-24
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950090)American Laboratory Products Co., Ltd.1995-04-21
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) (K950089)American Laboratory Products Co., Ltd.1995-04-21
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950088)American Laboratory Products Co., Ltd.1995-04-21
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (K931311)Nichols Institute1993-05-14
QUANTA LITE(TM) THYROID M ELISA (K930485)Inova Diagnostics, Inc.1993-03-16
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME (K930274)Joldon Diagnostics1993-02-23
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT (K925194)Joldon Diagnostics1993-02-05
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA (K925826)Clark Laboratories, Inc.1993-01-26
AUTOSTAT ANTITHYROGLOBIN (K925784)Cogent Diagnotics , Ltd.1993-01-21
AUTOSTAT ANTI-THYROID MICROSOMAL KIT (K925785)Cogent Diagnotics , Ltd.1993-01-21
ELIAS TGAB (K925922)Elias U.S.A., Inc.1993-01-14
ELIAS TMAB (K925923)Elias U.S.A., Inc.1993-01-14
SYNELISA TGAB (K915134)Elias U.S.A., Inc.1992-04-08
SYNELISA TMAB (K915133)Elias U.S.A., Inc.1992-04-08
SYNELISA TGAB/TMAB (K915135)Elias U.S.A., Inc.1992-04-08
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT (K915429)Kronus1992-03-30
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT (K915428)Kronus1992-03-30
IMMUNOWELL THYROGLOBULIN TEST (K905485)General Biometrics, Inc.1991-01-25
NOVA LITE TM THYROID (K904224)Inova Diagnostics, Inc.1990-10-15
ANTI-THYROGLOBULIN TEST KIT (K894203)Kronus1989-07-25
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (K894364)Kronus1989-07-25
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST (K881933)Kallestad Diag, A Div. of Erbamont, Inc.1988-06-06
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT (K871193)Cronus1987-05-15
SERA-TEK MICROSOMAL ANTIBODY TEST (K865053)Miles Laboratories, Inc.1987-02-18
125-I TSH RECEPTOR ANTIBODY KIT (K863006)Cronus1986-09-08
TSH RECEPTOR ANTIBODY KIT 125I TSH (K841580)Clinetics Corp.1984-10-22
MEDICA IIF-ANTI-THYROID ANTIBODY TEST (K843343)Medical Diagnostics, Ca.1984-10-22
CORDIA TG (K821489)Cordis Corp.1982-06-09
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (K810982)Immuno-Products Industries1981-05-01
AGGLUTINOTEST-THYROGLOBULIN (K791458)Volu Sol Medical Industries1979-12-31
TEST, (IVDP) THYROID ANTIBODY (K760154)Zeus Scientific, Inc.1976-07-20

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