Cleared Traditional

K863682 - PATHFINDER(TM) SPECIMEN COLLECTION KIT

K863682 is an FDA 510(k) clearance for PATHFINDER(TM) SPECIMEN COLLECTION KIT, manufactured by Kallestad Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K863682 · Kallestad Laboratories, Inc. · Microbiology device
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Oct 1986
Decision
21d
Days
Class 1
Risk

K863682 is an FDA 510(k) clearance for the PATHFINDER(TM) SPECIMEN COLLECTION KIT. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 10, 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 866.2390 - 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 - K863682

510(k) Number K863682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date October 10, 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.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K863682.
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · Precision Dynamics Corp. · Jul 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · Boots-Celltech Diagnostics, Inc. · Apr 1987
CARY BLAIR TRANSPORT MEDIUM
K864237 · Mds Laboratories, Inc. · Mar 1987
BUFFERED GLYCEROL SALINE
K863602 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
K863164 · Precision Dynamics Corp. · Aug 1986