Cleared Traditional

K221990 - Access Total ßhCG (5th IS) (FDA 510(k) Clearance)

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

K221990 · Beckman Coulter, Inc. · Chemistry device
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Dec 2022
Decision
174d
Days
Class 2
Risk

K221990 is an FDA 510(k) clearance for the Access Total ßhCG (5th IS). Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 27, 2022 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K221990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2022
Decision Date December 27, 2022
Days to Decision 174 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
86d slower than avg
Panel avg: 88d · This submission: 174d
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 K221990.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
K233581 · Ortho-Clinical Diagnostics · May 2024
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
Elecsys HCG STAT
K203227 · Roche Diagnostics · Aug 2021
ADVIA Centaur® Total hCG assay
K200210 · Siemens Healthcare Diagnostics, Inc. · Jul 2021