Cleared Traditional

K844721 - INNOFLUOR PRIMIDONE

K844721 is the FDA 510(k) clearance for INNOFLUOR PRIMIDONE by Innotron Diagnostics. It is a Class 1 Toxicology device (product code LKT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K844721 · Innotron Diagnostics · Toxicology device
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Jan 1985
Decision
35d
Days
Class 1
Risk

K844721 is an FDA 510(k) clearance for the INNOFLUOR PRIMIDONE. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Innotron Diagnostics (Irvine, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.3480 - the FDA toxicology 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 Innotron Diagnostics devices

Submission Details

510(k) Number K844721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1984
Decision Date January 08, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
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 15
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K844721.
CELLMATICS RSV DETECTION SYSTEM
K862321 · Difco Laboratories, Inc. · Aug 1986
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
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527 · Ortho Diagnostic Systems, Inc. · Aug 1984
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
K831924 · Electro-Nucleonics Laboratories, Inc. · Aug 1983