Cleared Traditional

K993732 - BVBLUE

K993732 is an FDA 510(k) clearance for BVBLUE, manufactured by Gryphus Diagnostics, LLC. The device is a Class 1 Chemistry device with product code MXB cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K993732 · Gryphus Diagnostics, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
193d
Days
Class 1
Risk

K993732 is an FDA 510(k) clearance for the 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 May 15, 2000 after a review of 193 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Gryphus Diagnostics, LLC devices

FDA 510(k) Submission Details - K993732

510(k) Number K993732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date May 15, 2000
Days to Decision 193 days
Submission Type Traditional
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
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

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.