Lumipulse G whole PTH
FDA 510(k) K190702 · Fujirebio Diagnostics,Inc.
510(k) numberK190702
Submission
- Device name
- Lumipulse G whole PTH
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- March 18, 2019
- Decision date
- August 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1545
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STATCEW · Traditional | Roche Diagnostics | 03/22/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | Ortho Clinical Diagnostics | 09/05/2023SE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2017SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | Immunodiagnostic Systems , Ltd. | 01/31/2017SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 06/22/2015SE |
| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/05/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 11/08/2013SE |
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics | 03/21/2013SE |
| K103325 | Ids-Isys Intact PTHCEW · Traditional | Immunodiagnostic Systems , Ltd. | 02/03/2012SE |
More from Immunodiagnostic Systems , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1OVK · Traditional | 12/16/2025SE |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET · Traditional | 05/16/2025SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | 09/04/2020SE |
| K192380 | ST Aia-Pack BNPNBC · Traditional | 08/24/2020SE |
| K200997 | Lumipulse G CA19-9-NNIG · Special | 05/14/2020SE |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional | 12/10/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | 07/28/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | 01/12/2017SE |
Questions and answers
When was Lumipulse G whole PTH cleared by the FDA?
Lumipulse G whole PTH (K190702) received a 510(k) decision of Substantially Equivalent on August 30, 2019, 165 days after the submission was received.
What is the product code of K190702?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.