Cleared Traditional

K954298 - VIROTROL IV

K954298 is an FDA 510(k) clearance for VIROTROL IV, manufactured by Blackhawk Biosystems, Inc.. The device is a Class 1 Microbiology device with product code JJY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K954298 · Blackhawk Biosystems, Inc. · Microbiology device
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Nov 1995
Decision
48d
Days
Class 1
Risk

K954298 is an FDA 510(k) clearance for the VIROTROL IV. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Blackhawk Biosystems, Inc. (San Ramon, US). The FDA issued a Cleared decision on November 1, 1995 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Blackhawk Biosystems, Inc. devices

FDA 510(k) Submission Details - K954298

510(k) Number K954298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date November 01, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

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