Cleared Special

K994110 - LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K994110 is an FDA 510(k) clearance for LIPOPROTEIN (A) SPQ III ANTIBODY REAGEN..., manufactured by Diasorin/American Standard Companies. The device is a Class 2 Chemistry device with product code DFC cleared through the Special 510(k) pathway after a 15-day FDA review.

K994110 · Diasorin/American Standard Companies · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
15d
Days
Class 2
Risk

K994110 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/American Standard Companies (Columbia, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 15 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.

FDA 510(k) Submission Details - K994110

510(k) Number K994110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date December 21, 1999
Days to Decision 15 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
74d faster than avg
Panel avg: 89d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

DFC Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K994110.
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K000121 · Beckman Coulter, Inc. · May 2000
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K990595 · Roche Diagnostics Corp. · Apr 1999
K994110 · LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
Download PDF FDA Summary Diasorin/American Sta…