Cleared Traditional

K881125 - PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLL...

K881125 is the FDA 510(k) clearance for PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLL... by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881125 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Mar 1988
Decision
7d
Days
Class 1
Risk

K881125 is an FDA 510(k) clearance for the PATHFINDER(TM) CHLAMYDIA EIA BRUSH 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 March 23, 1988 after a review of 7 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 K881125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1988
Decision Date March 23, 1988
Days to Decision 7 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
95d faster than avg
Panel avg: 102d · This submission: 7d
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 16
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K881125.
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1987
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984