Cleared Traditional

Elecsys HCG STAT

K203227 · Roche Diagnostics · Chemistry
Aug 2021
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K203227 is an FDA 510(k) clearance for the Elecsys HCG STAT, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on August 18, 2021, 289 days after receiving the submission on November 2, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K203227 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2020
Decision Date August 18, 2021
Days to Decision 289 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

Similar Devices — DHA System, Test, Human Chorionic Gonadotropin

All 71
VITROS Immunodiagnostic Products Total ?-hCG II Reagent Pack
K233581 · Ortho-Clinical Diagnostics · May 2024
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
K223690 · Shenzhen Yhlo Biotech Co., Ltd. · Dec 2023
Alinity i Total ?-hCG Reagent Kit, GLP systems Track
K230937 · Abbott Laboratories · Jun 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
K230790 · Abbott Laboratories · May 2023
Access Total ?hCG (5th IS)
K221990 · Beckman Coulter, Inc. · Dec 2022
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
K212221 · Diazyme Laboratories, Inc. · Dec 2021