Cleared Traditional

K942295 - VIROTROL TORCH

K942295 is an FDA 510(k) clearance for VIROTROL TORCH, 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 148-day FDA review.

K942295 · Blackhawk Biosystems, Inc. · Microbiology device
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Oct 1994
Decision
148d
Days
Class 1
Risk

K942295 is an FDA 510(k) clearance for the VIROTROL TORCH. 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 October 7, 1994 after a review of 148 days - within the typical 510(k) review window.

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

View all Blackhawk Biosystems, Inc. devices

FDA 510(k) Submission Details - K942295

510(k) Number K942295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1994
Decision Date October 07, 1994
Days to Decision 148 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
46d slower than avg
Panel avg: 102d · This submission: 148d
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)

All 573
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