Cleared Traditional

K861628 - WELLCOZYME ROTAVIRUS WZ01

K861628 is the FDA 510(k) clearance for WELLCOZYME ROTAVIRUS WZ01 by Wellcome Diagnostics. It is a Class 1 Microbiology device (product code LIQ) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K861628 · Wellcome Diagnostics · Microbiology device
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Jan 1987
Decision
267d
Days
Class 1
Risk

K861628 is an FDA 510(k) clearance for the WELLCOZYME ROTAVIRUS WZ01. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 267 days - an extended review cycle.

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 Wellcome Diagnostics devices

Submission Details

510(k) Number K861628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date January 21, 1987
Days to Decision 267 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 102d · This submission: 267d
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.

Regulatory Peers - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 19
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K861628.
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc. · Jan 1989
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · Abbott Laboratories · May 1988
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · Abbott Laboratories · Dec 1987
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · Kallestad Laboratories, Inc. · Oct 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · Bartels Immunodiagnostic Supplies, Inc. · Jul 1986
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · Kallestad Laboratories, Inc. · Nov 1985