Cleared Traditional

K884761 - MODIFIED CELL-MATICS HERPES SIMPLEX VIR...

K884761 is the FDA 510(k) clearance for MODIFIED CELL-MATICS HERPES SIMPLEX VIR... by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code GQN) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K884761 · Difco Laboratories, Inc. · Microbiology device
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Dec 1988
Decision
21d
Days
Class 2
Risk

K884761 is an FDA 510(k) clearance for the MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K884761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date December 05, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 Microbiology devices follow this clearance model.

Regulatory Peers - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

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