Cleared Special

K993669 - LIPOPROTEIN (A) SPQ III ANTIBODY REAGEN...

K993669 is the FDA 510(k) clearance for LIPOPROTEIN (A) SPQ III ANTIBODY REAGEN... by DiaSorin, Inc.. It is a Class 2 Chemistry device (product code DFC) cleared through the Special 510(k) pathway after a 16-day FDA review.

K993669 · DiaSorin, Inc. · Chemistry device
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Nov 1999
Decision
16d
Days
Class 2
Risk

K993669 is an FDA 510(k) clearance for the 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. (Columbia, US). The FDA issued a Cleared decision on November 17, 1999 after a review of 16 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 K993669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date November 17, 1999
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 30
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