Cleared Traditional

K033426 - LIAISON N-TACT PTH

K033426 is an FDA 510(k) clearance for LIAISON N-TACT PTH, manufactured by DiaSorin, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K033426 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
108d
Days
Class 2
Risk

K033426 is an FDA 510(k) clearance for the LIAISON N-TACT PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on February 12, 2004 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 DiaSorin, Inc. devices

FDA 510(k) Submission Details - K033426

510(k) Number K033426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date February 12, 2004
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 74
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K033426.
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150 · Scantibodies Laboratory, Inc. · Jul 2005
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813 · Nichols Institute Diagnostics · Jun 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727 · Nichols Institute Diagnostics · Apr 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · Nichols Institute Diagnostics · Jan 2004
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K031534 · Scantibodies Laboratory, Inc. · Jul 2003
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472 · Nichols Institute Diagnostics · Oct 2002