Radioimmunoassay, Progesterone
FDA product code JLS · Class I (low risk) · 21 CFR 862.1620 · Clinical Chemistry
57510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Amersham Corp. 4
- Diagnostic Products Corp. 4
- Immuchem Corp. 2
- Serono-Baker Diagnostics, Inc. 2
- Diagnostic Systems Laboratories, Inc. 2
- Boehringer Mannheim Corp. 2
- Biotecx Laboratories, Inc. 2
- Baxter Diagnostics, Inc. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Radioassay Systems Laboratories, Inc. 2
- Immunalysis Corporation 1
- Armkel, LLC 1
- Cambridge Nuclear Corp. 1
- Damon Corp. 1
- Corning Medical & Scientific 1
- Ibl GmbH 1
- Sorin Biomedica, Fiat, USA, Inc. 1
- Cis Radiopharmaceuticals, Inc. 1
- Calbiochem-Behring Corp. 1
- Serono Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | Ibl GmbH | 07/22/2004SE |
| K973898 | Progesterone ElisaJLS · Traditional | Kmi Diagnostics, Inc. | 11/13/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 06/24/1997SE |
| K971725 | Opus ProgesteroneJLS · Traditional | Behring Diagnostics, Inc. | 06/18/1997SE |
| K964841 | Elecsys Progesterone AssayJLS · Traditional | Boehringer Mannheim Corp. | 03/24/1997SE |
| K965084 | Vidas Proesterone (PRG) (30 409)JLS · Traditional | bioMerieux, Inc. | 01/09/1997SE |
| K955025 | Axsym ProgesteroneJLS · Traditional | Abbott Laboratories | 03/07/1996SE |
| K955769 | Access Progesterone AssayJLS · Traditional | Bio-Rad Laboratories, Inc. | 02/05/1996SE |
| K952075 | Progesterone Assay for the Technicon Immuno 1 System In-Bitro Diagnostic SystemJLS · Traditional | Bayer Corp. | 06/13/1995SE |
| K951630 | Auraflex Progesterone 150TEST PackJLS · Traditional | Organon Teknika Corp. | 05/08/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | Baxter Diagnostics, Inc. | 04/11/1995SE |
| K944211 | Immulite ProgesteroneJLS · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K935138 | Immulite ProgesteroneJLS · Traditional | Diagnostic Products Corp. | 01/11/1994SE |
| K933128 | Synelisa ProgesteroneJLS · Traditional | Elias U.S.A., Inc. | 11/05/1993SE |
| K933269 | Aia-Pack(R) Prog AssayJLS · Traditional | Tosoh Medics, Inc. | 10/22/1993SE |
| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | Immunotech Corp. | 10/22/1993SE |
| K933635 | Stratus Progesterone Flourometric ImmunoassayJLS · Traditional | Baxter Diagnostics, Inc. | 10/08/1993SE |
| K932955 | Ciba Corning Acs Progesterone ImmunoassayJLS · Traditional | Ciba Corning Diagnostics Corp. | 08/02/1993SE |
| K923410 | Fiagen ProgesteroneJLS · Traditional | Cyberfluor, Inc. | 12/03/1992SE |
| K920230 | Affinity PRGJLS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/18/1992SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | Serono-Baker Diagnostics, Inc. | 10/23/1991SE |
| K911512 | Milenia ProgesteroneJLS · Traditional | Diagnostic Products Corp. | 05/22/1991SE |
| K910683 | Enzymun-Test ProgesteroneJLS · Traditional | Boehringer Mannheim Corp. | 04/08/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | Pantex, Div. Bio-Analysis, Inc. | 09/08/1989SE |
| K890836 | Ria-Gnost ProgesteroneJLS · Traditional | Cambridge Medical Technology | 03/16/1989SE |
| K890428 | Delfia Progesterone KitJLS · Traditional | Pharmacia, Inc. | 02/23/1989SE |
| K884794 | Progesterone Serozyme Immunoenzymetric AssayJLS · Traditional | Serono-Baker Diagnostics, Inc. | 02/02/1989SE |
| K884100 | Amerlite Progesterone Assay, LAN.0079/2079 240/144JLS · Traditional | Amersham Corp. | 11/10/1988SE |
| K880934 | Modified Amerlex-M Progesterone Radioimmuno. KitJLS · Traditional | Amersham Corp. | 04/18/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | Serono Diagnostics, Inc. | 10/20/1987SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | Biotecx Laboratories, Inc. | 04/13/1987SE |
| K864855 | Amerlex-M Progesterone Radioimmunoassay KitJLS · Traditional | Amersham Corp. | 02/25/1987SE |
| K864156 | Progesterone System by EiaJLS · Traditional | Intl. Bioclinical, Inc. | 11/24/1986SE |
| K860924 | Ramp Progesturine PDG ASSAY--48 Test KitJLS · Traditional | Monoclonal Antibodies, Inc. | 07/02/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | Immuchem Corp. | 02/28/1986SE |
| K854675 | DSL Androstenedione Ria (DSL #4200)JLS · Traditional | Diagnostic Systems Laboratories, Inc. | 01/28/1986SE |
| K854649 | DSL Progesterone Ria (DSL #3400)JLS · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1985SE |
| K850056 | Leeco Progesterone-Quant Diagnostic Test KitJLS · Traditional | Leeco Diagnostics, Inc. | 02/06/1985SE |
| K845026 | Amerlex-M Progesterone Radioimmunoassay Kit CodeJLS · Traditional | Amersham Corp. | 02/01/1985SE |
| K841333 | Progesterone Direct Ria Kit-RadioimmJLS · Traditional | Biotecx Laboratories, Inc. | 05/02/1984SE |
| K840886 | Hydroxyprogesterone by Ria 17AJLS · Traditional | Radioassay Systems Laboratories, Inc. | 04/18/1984SE |
| K832694 | Diria-Progk ImmunoassayJLS · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 01/11/1984SE |
| K832297 | HYDROXYPROGESTERONE-17JLS · Traditional | Diagnostics Biochem Canada, Inc. | 09/01/1983SE |
| K830880 | Immo Phase Direct Progesterone Radio-JLS · Traditional | Corning Medical & Scientific | 04/18/1983SE |
| K820686 | Liquisol Progesterone RadioimmunoJLS · Traditional | Damon Corp. | 04/01/1982SE |
| K820534 | Coat-A-Count Progesterone Kia KitJLS · Traditional | Diagnostic Products Corp. | 03/16/1982SE |
| K813484 | Progesterone Kit by RiaJLS · Traditional | Immuchem Corp. | 12/22/1981SE |
| K811907 | Progesterone Direct Ria Kit (125I)JLS · Traditional | Immunalysis Corporation | 07/23/1981SE |
| K811369 | Natal-Tec ProgesteroneJLS · Traditional | Armkel, LLC | 05/29/1981SE |
| K810804 | Progesterone KitJLS · Traditional | Cambridge Nuclear Corp. | 04/01/1981SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | Nordiclab Intl. | 05/14/1980SE |
| K800126 | RSL (125 L) Progesterone KitJLS · Traditional | Radioassay Systems Laboratories, Inc. | 02/13/1980SE |
| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | Cis Radiopharmaceuticals, Inc. | 07/24/1979SE |
| K790911 | Ria of ProgesteroneJLS · Traditional | Calbiochem-Behring Corp. | 06/27/1979SE |
| K790440 | ProgesteroneJLS · Traditional | Serono Laboratories, Inc. | 05/03/1979SE |
| K782009 | Ria Kit, ProgesteroneJLS · Traditional | The Upjohn Co. | 03/02/1979SE |
| K770732 | Reagent System, Progesterone, AriaJLS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0866-2023 Class II | VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0424-2022 Class II | VIDAS PRG Progesterone, REF 30409-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-2290-2019 Class II | IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN…There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low… | Siemens Healthcare Diagnostics, Inc. | 07/10/2019Terminated |
| Z-2289-2019 Class II | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low… | Siemens Healthcare Diagnostics, Inc. | 07/10/2019Terminated |
| Z-2410-2019 Class II | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human…Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in… | DRG Instruments GmbH | 06/06/2019Terminated |
| Z-0668-2019 Class II | Alinity i Progesterone Reagent Kit, List Number 08P3620Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | Abbott Ireland Diagnostics Division | 11/21/2018Terminated |
| Z-2091-2018 Class II | ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-0826-2018 Class II | ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due… | Tosoh Bioscience Inc | 02/13/2018Terminated |
| Z-0825-2018 Class II | ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due… | Tosoh Bioscience Inc | 02/13/2018Terminated |
| Z-1327-2018 Class II | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1)…Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot… | Arrow International Inc | 12/22/2017Terminated |
| Z-1421-2017 Class II | IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | Siemens Healthcare Diagnostics, Inc | 01/04/2017Terminated |
| Z-1420-2017 Class II | IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | Siemens Healthcare Diagnostics, Inc | 01/04/2017Terminated |
| Z-1419-2017 Class II | Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | Siemens Healthcare Diagnostics, Inc | 01/04/2017Terminated |
| Z-1418-2017 Class II | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage:…DHEA-S causes falsely elevated progesterone results. | Siemens Healthcare Diagnostics, Inc | 01/04/2017Terminated |
| Z-1231-2015 Class II | ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog…ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL… | Siemens Healthcare Diagnostics, Inc | 01/27/2015Terminated |
| Z-1230-2015 Class II | ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number:…ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL… | Siemens Healthcare Diagnostics, Inc | 01/27/2015Terminated |
| Z-1229-2015 Class II | ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number:…ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL… | Siemens Healthcare Diagnostics, Inc | 01/27/2015Terminated |
| Z-2620-2010 | Access Immunoassay Systems PROGESTERONE, Part Number: 33550The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot… | Beckman Coulter Inc. | 02/17/2010Terminated |
| Z-0524-2009 | IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the…Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is… | Siemens Medical Solutions Diagnostics | 07/21/2008Terminated |