Cleared Traditional

K192790 - Atellica IM Total hCG (ThCG)

K192790 is the FDA 510(k) clearance for Atellica IM Total hCG (ThCG) by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K192790 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Oct 2019
Decision
30d
Days
Class 2
Risk

K192790 is an FDA 510(k) clearance for the Atellica IM Total hCG (ThCG). Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 30, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K192790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date October 30, 2019
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DHA System, Test, Human Chorionic Gonadotropin

All 42
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K192790.
Elecsys HCG STAT
K203227 · Roche Diagnostics · Aug 2021
ADVIA Centaur® Total hCG assay
K200210 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
MAGLUMI 2000 HCG/ß-HCG
K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Jan 2020
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · Abbott Laboratories · Oct 2017
Diazyme DZ-Lite Total beta-hCG Test System
K163418 · Diazyme Laboratories · Aug 2017
ACCESS TOTAL BHCG (5TH IS)
K130020 · Beckman Coulter, Inc. · Oct 2013