Cleared Special

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (K033302) - FDA 510(k) Clearance

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

K033302 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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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
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 85
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