Cleared Traditional

K884192 - RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION

K884192 is an FDA 510(k) clearance for RSV IFA TEST KIT FOR DIRECT ANTIGEN DET..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LKT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K884192 · Baxter Diagnostics, Inc. · Microbiology device
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Nov 1988
Decision
47d
Days
Class 1
Risk

K884192 is an FDA 510(k) clearance for the RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 47 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K884192

510(k) Number K884192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date November 22, 1988
Days to Decision 47 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
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

LKT Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (LKT) and FDA review panel - the closest regulatory comparables to K884192.
RSV-MAB TEST
K912842 · Gull Laboratories, Inc. · Dec 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · Baxter Diagnostics, Inc. · Sep 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · Vitek Systems, Inc. · Sep 1991
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · Gull Laboratories, Inc. · Aug 1988
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082 · Medical Diagnostic Technologies, Inc. · Jul 1987
CELLMATICS RSV DETECTION SYSTEM
K862321 · Difco Laboratories, Inc. · Aug 1986