Cleared Traditional

K862917 - PATHFINDER ROTAVIRUS CHEMILUMINESCENT

K862917 is an FDA 510(k) clearance for PATHFINDER ROTAVIRUS CHEMILUMINESCENT, manufactured by Kallestad Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K862917 · Kallestad Laboratories, Inc. · Microbiology device
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Oct 1986
Decision
82d
Days
Class 1
Risk

K862917 is an FDA 510(k) clearance for the PATHFINDER ROTAVIRUS CHEMILUMINESCENT. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 22, 1986 after a review of 82 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 Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K862917

510(k) Number K862917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date October 22, 1986
Days to Decision 82 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
20d faster than avg
Panel avg: 102d · This submission: 82d
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 27
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K862917.
ROTASCREEN EIA
K873740 · Mercia Diagnostics , Ltd. · Nov 1987
WELLCOZYME ROTAVIRUS WZ01
K861628 · Wellcome Diagnostics · Jan 1987
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · Wellcome Diagnostics · Oct 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · Bartels Immunodiagnostic Supplies, Inc. · Jul 1986
ROTALEX
K860529 · Orion Corp. · Mar 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · Orion Diagnostica, Inc. · Jan 1986