Cleared Special

K042281 - MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

K042281 is an FDA 510(k) clearance for MODIFICATION TO ACCESS HYPERSENSITIVE H..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Special 510(k) pathway after a 23-day FDA review.

K042281 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
23d
Days
Class 2
Risk

K042281 is an FDA 510(k) clearance for the MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY. 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 September 16, 2004 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042281

510(k) Number K042281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date September 16, 2004
Days to Decision 23 days
Submission Type Special
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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

JLW Device Classification - Class 2, Special Controls

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 238
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K042281.
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K030912 · Thryotec · Jul 2003
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
K042281 · MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
Download PDF FDA Summary Beckman Coulter, Inc.