Cleared Traditional

MODIFIED PATHFINDER SPECIMEN COLLECTION KIT (K870963) - FDA 510(k) Clearance

Class I Microbiology device.

K870963 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Apr 1987
Decision
29d
Days
Class 1
Risk

K870963 is an FDA 510(k) clearance for the MODIFIED PATHFINDER SPECIMEN COLLECTION KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on April 8, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K870963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1987
Decision Date April 08, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 62
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K870963.
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NOVAPATH SPECIMEN COLLECTION KIT
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NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · Syva Co. · Sep 1983