Cleared Traditional

K221225 - Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (FDA 510(k) Clearance)

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

K221225 · Beckman Coulter, Inc. · Chemistry device
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Nov 2022
Decision
196d
Days
Class 2
Risk

K221225 is an FDA 510(k) clearance for the Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 196 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 K221225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2022
Decision Date November 10, 2022
Days to Decision 196 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
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 241
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K221225.
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Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · Siemens Healthcare Diagnostics · Apr 2025
Maverick Diagnostic System TC1000
K234091 · Genalyte, Inc. · Jul 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · Siemens Healthcare Diagnostics, Inc. · Apr 2024
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
K222116 · Siemens Healthcare Diagnostics, Inc. · Jul 2023