Cleared Traditional

K860529 - ROTALEX

K860529 is an FDA 510(k) clearance for ROTALEX, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860529 · Orion Corp. · Microbiology device
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Mar 1986
Decision
21d
Days
Class 1
Risk

K860529 is an FDA 510(k) clearance for the ROTALEX. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on March 4, 1986 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orion Corp. devices

FDA 510(k) Submission Details - K860529

510(k) Number K860529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date March 04, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

LIQ Device Classification - Class 1, General Controls

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 25
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K860529.
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · Wellcome Diagnostics · Oct 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · Kallestad Laboratories, Inc. · Oct 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · Bartels Immunodiagnostic Supplies, Inc. · Jul 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · Orion Diagnostica, Inc. · Jan 1986
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · Kallestad Laboratories, Inc. · Nov 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · Armkel, LLC · Nov 1985