Cleared Traditional

K200210 - ADVIA Centaur® Total hCG assay (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200210 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Jul 2021
Decision
532d
Days
Class 2
Risk

K200210 is an FDA 510(k) clearance for the ADVIA Centaur® Total hCG assay. 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 July 13, 2021 after a review of 532 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K200210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2020
Decision Date July 13, 2021
Days to Decision 532 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
444d slower than avg
Panel avg: 88d · This submission: 532d
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 71
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K200210.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
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Alinity i Total ß-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 ßhCG (5th IS)
K221990 · Beckman Coulter, Inc. · Dec 2022
Elecsys HCG STAT
K203227 · Roche Diagnostics · Aug 2021