Cleared Traditional

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (K190298) - FDA 510(k) Clearance

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

K190298 · Beckman Coulter Biomedical GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
235d
Days
Class 2
Risk

K190298 is an FDA 510(k) clearance for the DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, .... Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Beckman Coulter Biomedical GmbH (Munich, DE). The FDA issued a Cleared decision on October 4, 2019 after a review of 235 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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 Biomedical GmbH devices

Submission Details

510(k) Number K190298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date October 04, 2019
Days to Decision 235 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
147d slower than avg
Panel avg: 88d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 77
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K190298.
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · Axis-Shield Diagnostics, Ltd. · Jul 2024
Access Vitamin B12
K223289 · Beckman Coulter, Inc. · Dec 2022
LIAISON Vitamin B12
K192064 · DiaSorin, Inc. · Oct 2019
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · Abbott Laboratories · Oct 2011
ABBOTT AXSYM B12
K051327 · Abbott Laboratories · Aug 2005