Cleared Traditional

K912838 - BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO

K912838 is an FDA 510(k) clearance for BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZ..., 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 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

FDA 510(k) Submission Details - K912838

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.

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 K912838.
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · Diagnostic Products Corp. · Dec 1994
RSV ANTIGEN TEST
K942173 · Neogenex · Jun 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