Cleared Special

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K001118) - FDA 510(k) Clearance

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

K001118 · DiaSorin, Inc. · Chemistry device
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Apr 2000
Decision
18d
Days
Class 2
Risk

K001118 is an FDA 510(k) clearance for the MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Ellicott City, US). The FDA issued a Cleared decision on April 25, 2000 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K001118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date April 25, 2000
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 41
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