Cleared Special

K033302 - NICHOLS ADVANTAGE BIO-INTACT PTH (1-84)...

K033302 is the FDA 510(k) clearance for NICHOLS ADVANTAGE BIO-INTACT PTH (1-84)... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CEW) cleared through the Special 510(k) pathway after a 104-day FDA review.

K033302 · Nichols Institute Diagnostics · Chemistry device
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Jan 2004
Decision
104d
Days
Class 2
Risk

K033302 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on January 26, 2004 after a review of 104 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K033302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date January 26, 2004
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K033302.
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
LIAISON N-TACT PTH
K033426 · DiaSorin, Inc. · Feb 2004
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472 · Nichols Institute Diagnostics · Oct 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · Diagnostic Products Corp. · Aug 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · Diagnostic Systems Laboratories, Inc. · May 2002