Cleared Abbreviated

CHEMWELL, ALSO KNOWN AS PROJECT 2900 (K013420) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K013420 · Awareness Technology, Inc. · Chemistry device
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Jul 2002
Decision
277d
Days
Class 2
Risk

K013420 is an FDA 510(k) clearance for the CHEMWELL, ALSO KNOWN AS PROJECT 2900. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on July 19, 2002 after a review of 277 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Awareness Technology, Inc. devices

Submission Details

510(k) Number K013420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date July 19, 2002
Days to Decision 277 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 88d · This submission: 277d
Pathway characteristics
Standards-based clearance path.

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 96
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K013420.
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
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MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · Beckman Coulter, Inc. · Sep 2004
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
ABBOTT ARCHITECT TSH
K983442 · Abbott Laboratories · Nov 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · Bayer Corp. · Jun 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · Abbott Laboratories · Apr 1998