Cleared Traditional

K912838 - BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZ...

K912838 is the FDA 510(k) clearance for BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZ... by Baxter Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LKT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K912838 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1991
Decision
93d
Days
Class 1
Risk

K912838 is an FDA 510(k) clearance for the BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO. Classified as Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 93 days - within the typical 510(k) review window.

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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K912838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date September 27, 1991
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
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 K912838.
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · Diagnostic Products Corp. · Mar 1999
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp. · Dec 1994
RSV-MAB TEST
K912842 · Gull Laboratories, Inc. · Dec 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
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · Gull Laboratories, Inc. · Aug 1988