Atlas FDA

CEW

86 FDA 510(k) clearances · Product code

73 daysmedian time to decision
172 days90th percentile
86clearances measured

FDA profile

Official device name
Radioimmunoassay, Parathyroid Hormone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1545
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 57 · 2022: 188 · 2023: 82 · 2024: 67 · 2025: 38 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elecsys PTH , Elecsys PTH STAT (K231927)Roche Diagnostics2024-03-22
Access Intact PTH (K232791)Beckman Coulter, Inc.2024-03-01
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197)Ortho Clinical Diagnostics2023-09-05
Lumipulse G whole PTH (K190702)Fujirebio Diagnostics,Inc.2019-08-30
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658)Siemens Healthcare Diagnostics, Inc.2017-05-23
IDS-iSYS Intact PTHN (K161158)Immunodiagnostic Systems , Ltd.2017-01-31
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (K150879)DiaSorin, Inc.2015-06-22
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601)Siemens Healthcare Diagnostics, Inc.2014-02-05
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515)DiaSorin, Inc.2013-11-08
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981)Siemens Healthcare Diagnostics2013-03-21
IDS-ISYS INTACT PTH (K103325)Immunodiagnostic Systems , Ltd.2012-02-03
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921)Ortho-Clinical Diagnostics2010-10-22
ROCHE ELECSYS PTH TEST SYSTEM (K070709)Roche Diagnostics Corp.2007-07-13
ST AIA-PACK INTACT PTH ASSAY (K063605)Tosoh Bioscience, Inc.2007-06-21
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 (K063232)Biokit, S.A.2007-06-19
ELECSYS PTH TEST SYSTEM (K070391)Roche Diagnostics Corp.2007-03-20
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 (K061190)Beckman Coulter, Inc.2006-09-15
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 (K060420)Scantibodies Laboratory, Inc.2006-03-01
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K060348)Scantibodies Laboratory, Inc.2006-02-27
IMMULITE/IMMULITE 1000 TURBO INTACT PTH (K053533)Diagnostic Products Corporation2006-02-03
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 (K051888)Scantibodies Laboratory, Inc.2005-10-18
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 (K051810)Scantibodies Laboratory, Inc.2005-09-09
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K051150)Scantibodies Laboratory, Inc.2005-07-26
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 (K051141)Scantibodies Laboratory, Inc.2005-07-26
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (K040813)Nichols Institute Diagnostics2004-06-08
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (K033727)Nichols Institute Diagnostics2004-04-22
LIAISON N-TACT PTH (K033426)DiaSorin, Inc.2004-02-12
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (K033302)Nichols Institute Diagnostics2004-01-26
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 (K031534)Scantibodies Laboratory, Inc.2003-07-30
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) (K022472)Nichols Institute Diagnostics2002-10-09
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (K022603)Diagnostic Products Corp.2002-08-21
AXSYM INTACT PTH, MODEL 2G06 (K020945)Diagnostic Systems Laboratories, Inc.2002-05-31
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY (K013992)Nichols Institute Diagnostics2001-12-13
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 (K013566)Diagnostic Products Corp.2001-11-20
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 (K011505)Diagnostic Products Corp.2001-07-02
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 (K004038)Scantibodies Laboratory, Inc.2001-04-30
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 (K001411)Scantibodies Laboratory, Inc.2000-08-21
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT (K000471)Future Diagnostics B.V.2000-04-11
ELECSYS PARATHYROID HORMONE TEST SYSTEM (K992680)Roche Diagnostics Corp.1999-09-28
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ (K992105)Diagnostic Products Corp.1999-07-06
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA (K974306)Sangui Biotech, Inc.1997-12-23
ACTIVE INTACT PTH (K973514)Diagnostic Systems Laboratories, Inc.1997-10-31
AQUALITE INTACT PTH (K970483)Sealite Sciences, Inc.1997-04-14
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT (K962598)Nichols Institute Diagnostics1996-12-10
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT (K962033)Nichols Institute Diagnostics1996-09-27
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) (K954418)Nichols Institute Diagnostics1995-11-03
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) (K944788)Scantibodies Laboratory, Inc.1995-07-19
ACTIVE INTACT PTH ELISA (K952199)Diagnostic Systems Laboratories, Inc.1995-07-17
ELSA-PTH (K950211)Cis-Us, Inc.1995-04-13
GAMMA-BCT INTACT PTH (K942369)Immunodiagnostic Systems , Ltd.1994-09-20
OCTEIA INTACT PTH (K941878)I.D.S.1994-09-07
IMMUNLITE INTACT PTH (K934760)Diagnostic Products Corp.1993-12-10
COAT-A-COUNT INTACT PTH IRMA (K930008)Diagnostic Products Corp.1993-06-15
COTUBE PTH IRMA (K921949)Bio-Rad1992-09-02
N-TACT(R) PTH SP KIT (K921629)Incstar Corp.1992-05-14
VENTREX COATED TUBE INTACT PTH (K913434)Ventrex Laboratories, Inc.1991-10-25
LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (K903130)London Diagnostics, Inc.1990-09-25
PTH-MM II 125I RADIOIMMUNOASSAY (RIA) (K901711)Incstar Corp.1990-07-16
DSL I-PTH (DSL #8000) (K896294)Diagnostic Systems Laboratories, Inc.1989-11-21
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY (K882560)Ciba Corning Diagnostics Corp.1988-10-13
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) (K874299)Incstar Corp.1987-11-23
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 (K871970)Diagnostic Products Corp.1987-09-25
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY (K861797)Nichols Institute Diagnostics1986-07-22
C-TERMINAL PTH RIA KIT (K853784)Diagnostic Systems Laboratories, Inc.1985-10-04
PTH-RIA (K844735)Syncor Intl. Corp.1985-04-29
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (K850254)Cambridge Medical Technology1985-04-03
PARATHYROID HORMONE C-TERMINAL RIA KIT (K843871)Diagnostic Products Corp.1984-10-30
PARATHYROID HORMONE MID-MOLECULE RIA-KIT (K843870)Diagnostic Products Corp.1984-10-30
C-TERMINAL/MID-MOLECULE PARATHYROID - (K843685)Nichols Institute Diagnostics1984-10-11
PARATHYROID HORMONE ANALYSIS PRODUCT (K840379)Nichols Institute Diagnostics1984-04-04
C. PTH RADIOIMMUNOASSAY KIT-CPTHK (K833768)Sorin Biomedica, Fiat, USA, Inc.1983-12-29
PTH MR (K831470)Ramco Laboratories, Inc.1983-06-22
DAC-CEL PTH KIT RD51 (K831069)Wellcome Diagnostics1983-06-16
HUMAN INTRACT PARATHYROID HORMONE BY (K830664)Immuno Nuclear Corp.1983-05-09
MMH PTH RIA KIT (K830700)Diagnostic Systems1983-04-06
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT (K822944)Travenol Laboratories, S.A.1982-12-30
RADIOIMMUNOASSAY PARATHYROID HORMONE MID (K821131)Endocrine-Metabolic Center1982-06-02
MIN-MOLECULE PTH BY RADIOIMMUNOASSAY (K820228)Immuno Nuclear Corp.1982-03-11
C-TERMINAL PTH RIA TEST KIT, DSL-1000 (K813203)Diagnostic Systems Laboratories, Inc.1981-12-03
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT (K811566)Immuno Nuclear Corp.1981-06-25
N-TERMINAL HPTH BY RIA (K811418)Immuno Nuclear Corp.1981-06-24
PTH RIA 200 (K791128)Institut National Des Radioelements1979-09-27
RIA SYSTEM, PARATHYROID HORMONE (K782081)Iso-Tex Diagnostics1979-03-21
HORMONE KIT, PARATHYROID (K782010)Nichols Institute Diagnostics1979-01-10
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K772249)Kallestad Laboratories, Inc.1977-12-22
PTH RIA (K771783)Nichols Institute Diagnostics1977-10-14

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