Cleared Traditional

K023093 - ACCESS HYPERSENSITIVE HTSH ASSAY

K023093 is an FDA 510(k) clearance for ACCESS HYPERSENSITIVE HTSH ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K023093 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
68d
Days
Class 2
Risk

K023093 is an FDA 510(k) clearance for the 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 November 25, 2002 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023093

510(k) Number K023093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date November 25, 2002
Days to Decision 68 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
21d faster than avg
Panel avg: 89d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K023093.
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · Beckman Coulter, Inc. · Sep 2004
TSH-CTK-3 IRMA
K041014 · DiaSorin, Inc. · Jul 2004
THYRO TEST
K030912 · Thryotec · Jul 2003
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · Awareness Technology, Inc. · Jul 2002
PRAXSYS RELIA TSH TEST
K011527 · Praxsys Biosystems, Inc. · Aug 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
K011525 · Biosafe Laboratories, Inc. · Jul 2001
K023093 · ACCESS HYPERSENSITIVE HTSH ASSAY
Download PDF FDA Summary Beckman Coulter, Inc.