Cleared Special

MODIFICATION TO COATEST FACTOR VIII (K033631) - FDA 510(k) Clearance

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

K033631 · Instrumentation Laboratory CO · Hematology device
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Dec 2003
Decision
26d
Days
Class 2
Risk

K033631 is an FDA 510(k) clearance for the MODIFICATION TO COATEST FACTOR VIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K033631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2003
Decision Date December 15, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 189
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