Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CEW — Predicate Candidate Screening

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

73 daysmedian FDA review time

172 days90th percentile

86clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231927	Elecsys PTH , Elecsys PTH STAT	Roche Diagnostics	2024-03-22	266	0
K232791	Access Intact PTH	Beckman Coulter, Inc.	2024-03-01	172	1
K221197	VITROS Immunodiagnostic Products Intact PTH II Reagent Pack	Ortho Clinical Diagnostics	2023-09-05	498	0
K190702	Lumipulse G whole PTH	Fujirebio Diagnostics,Inc.	2019-08-30	165	0
K163658	ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay	Siemens Healthcare Diagnostics, Inc.	2017-05-23	151	0
K161158	IDS-iSYS Intact PTHN	Immunodiagnostic Systems , Ltd.	2017-01-31	281	0
K150879	LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1	DiaSorin, Inc.	2015-06-22	82	0
K133601	ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY	Siemens Healthcare Diagnostics, Inc.	2014-02-05	72	0
K132515	LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIER	DiaSorin, Inc.	2013-11-08	88	0
K121981	ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY	Siemens Healthcare Diagnostics	2013-03-21	258	2
K103325	IDS-ISYS INTACT PTH	Immunodiagnostic Systems , Ltd.	2012-02-03	448	0
K101921	VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, V	Ortho-Clinical Diagnostics	2010-10-22	105	1
K070709	ROCHE ELECSYS PTH TEST SYSTEM	Roche Diagnostics Corp.	2007-07-13	121	0
K063605	ST AIA-PACK INTACT PTH ASSAY	Tosoh Bioscience, Inc.	2007-06-21	199	0
K063232	ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROL	Biokit, S.A.	2007-06-19	237	2
K070391	ELECSYS PTH TEST SYSTEM	Roche Diagnostics Corp.	2007-03-20	39	0
K061190	ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 1695	Beckman Coulter, Inc.	2006-09-15	140	1
K060420	MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINO	Scantibodies Laboratory, Inc.	2006-03-01	12	0
K060348	MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (I	Scantibodies Laboratory, Inc.	2006-02-27	17	0
K053533	IMMULITE/IMMULITE 1000 TURBO INTACT PTH	Diagnostic Products Corporation	2006-02-03	46	0
K051888	TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSIO	Scantibodies Laboratory, Inc.	2005-10-18	98	0
K051810	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COA	Scantibodies Laboratory, Inc.	2005-09-09	66	0
K051150	TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT	Scantibodies Laboratory, Inc.	2005-07-26	83	0
K051141	WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICM	Scantibodies Laboratory, Inc.	2005-07-26	83	0
K040813	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMO	Nichols Institute Diagnostics	2004-06-08	70	0
K033727	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY	Nichols Institute Diagnostics	2004-04-22	146	1
K033426	LIAISON N-TACT PTH	DiaSorin, Inc.	2004-02-12	108	0
K033302	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040	Nichols Institute Diagnostics	2004-01-26	104	0
K031534	CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY	Scantibodies Laboratory, Inc.	2003-07-30	75	0
K022472	PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTR	Nichols Institute Diagnostics	2002-10-09	75	0
K022603	IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER	Diagnostic Products Corp.	2002-08-21	15	2
K020945	AXSYM INTACT PTH, MODEL 2G06	Diagnostic Systems Laboratories, Inc.	2002-05-31	67	0
K013992	NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID H	Nichols Institute Diagnostics	2001-12-13	9	0
K013566	IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1	Diagnostic Products Corp.	2001-11-20	25	2
K011505	IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TES	Diagnostic Products Corp.	2001-07-02	47	0
K004038	TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODE	Scantibodies Laboratory, Inc.	2001-04-30	123	0
K001411	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC	Scantibodies Laboratory, Inc.	2000-08-21	109	0
K000471	FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT	Future Diagnostics B.V.	2000-04-11	57	1
K992680	ELECSYS PARATHYROID HORMONE TEST SYSTEM	Roche Diagnostics Corp.	1999-09-28	49	1
K992105	IMMULITE TURBO INTACT PTH, MODEL LSKPTZ	Diagnostic Products Corp.	1999-07-06	14	0
K974306	SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA	Sangui Biotech, Inc.	1997-12-23	36	0
K973514	ACTIVE INTACT PTH	Diagnostic Systems Laboratories, Inc.	1997-10-31	44	0
K970483	AQUALITE INTACT PTH	Sealite Sciences, Inc.	1997-04-14	63	0
K962598	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMO	Nichols Institute Diagnostics	1996-12-10	161	0
K962033	CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT	Nichols Institute Diagnostics	1996-09-27	126	0
K954418	INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)	Nichols Institute Diagnostics	1995-11-03	42	0
K944788	INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHN	Scantibodies Laboratory, Inc.	1995-07-19	294	0
K952199	ACTIVE INTACT PTH ELISA	Diagnostic Systems Laboratories, Inc.	1995-07-17	68	2
K950211	ELSA-PTH	Cis-Us, Inc.	1995-04-13	84	0
K942369	GAMMA-BCT INTACT PTH	Immunodiagnostic Systems , Ltd.	1994-09-20	125	0

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