Cleared Traditional

K861172 - ROTAVIRUS LATEX AGGLUTINATION ASSAY (FDA 510(k) Clearance)

Class I Microbiology device.

K861172 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Jul 1986
Decision
95d
Days
Class 1
Risk

K861172 is an FDA 510(k) clearance for the ROTAVIRUS LATEX AGGLUTINATION ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K861172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date July 01, 1986
Days to Decision 95 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 102d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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.