Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
FDA 510(k) K212221 · Diazyme Laboratories, Inc.
510(k) numberK212221
Submission
- Device name
- Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- Applicant
- Diazyme Laboratories, Inc.
Poway, CA, US - Received
- July 16, 2021
- Decision date
- December 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | Ortho Clinical Diagnostics | 05/08/2024SE |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)DHA · Traditional | Shenzhen Yhlo Biotech Co., Ltd. | 12/11/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | Abbott Laboratories | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | Abbott Laboratories | 05/19/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA · Traditional | Abbott Laboratories | 10/23/2017SE |
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Questions and answers
When was Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer cleared by the FDA?
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 150 days after the submission was received.
What is the product code of K212221?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.