Cleared Traditional

K912842 - RSV-MAB TEST

K912842 is an FDA 510(k) clearance for RSV-MAB TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LKT cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K912842 · Gull Laboratories, Inc. · Microbiology device
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Dec 1991
Decision
166d
Days
Class 1
Risk

K912842 is an FDA 510(k) clearance for the RSV-MAB TEST. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 166 days - an extended review 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: 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K912842

510(k) Number K912842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date December 09, 1991
Days to Decision 166 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 102d · This submission: 166d
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 K912842.
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · Diagnostic Products Corp. · Mar 1999
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp. · Dec 1994
RSV ANTIGEN TEST
K942173 · Neogenex · Jun 1994
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · Baxter Diagnostics, Inc. · Sep 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · Vitek Systems, Inc. · Sep 1991
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · Baxter Diagnostics, Inc. · Nov 1988