Cleared Traditional

K862321 - CELLMATICS RSV DETECTION SYSTEM

K862321 is the FDA 510(k) clearance for CELLMATICS RSV DETECTION SYSTEM by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code LKT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K862321 · Difco Laboratories, Inc. · Microbiology device
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Aug 1986
Decision
64d
Days
Class 1
Risk

K862321 is an FDA 510(k) clearance for the CELLMATICS RSV DETECTION SYSTEM. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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 K862321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date August 21, 1986
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
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 - LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

All 14
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K862321.
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · Baxter Diagnostics, Inc. · Nov 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · Gull Laboratories, Inc. · Aug 1988
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082 · Medical Diagnostic Technologies, Inc. · Jul 1987
ABBOTT RSV EIA
K852472 · Abbott Laboratories · Sep 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1985
ORTHO* RSV ANTIGEN ELISA TEST SYS
K842047 · Ortho Diagnostic Systems, Inc. · Oct 1984