Cleared Special

K050755 - MODIFICATION TO BVBLUE

K050755 is an FDA 510(k) clearance for MODIFICATION TO BVBLUE, manufactured by Gryphus Diagnostics, LLC. The device is a Class 1 Chemistry device with product code MXB cleared through the Special 510(k) pathway after a 14-day FDA review.

K050755 · Gryphus Diagnostics, LLC · Chemistry device
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Apr 2005
Decision
14d
Days
Class 1
Risk

K050755 is an FDA 510(k) clearance for the MODIFICATION TO BVBLUE. Classified as Test, Vaginal, Bacterial Sialidase (product code MXB), Class I - General Controls.

Submitted by Gryphus Diagnostics, LLC (Rockville, US). The FDA issued a Cleared decision on April 6, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - 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 - K050755

510(k) Number K050755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2005
Decision Date April 06, 2005
Days to Decision 14 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 89d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MXB Device Classification - Class 1, General Controls

Product Code MXB Test, Vaginal, Bacterial Sialidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

K050755 · MODIFICATION TO BVBLUE
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