Cleared Traditional

K880031 - PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS

K880031 is an FDA 510(k) clearance for PATHFINDER(TM) DIRECT DETECTION SYS C. ..., manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. The device is a Class 1 Microbiology device with product code LJP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K880031 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Mar 1988
Decision
72d
Days
Class 1
Risk

K880031 is an FDA 510(k) clearance for the PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 17, 1988 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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

FDA 510(k) Submission Details - K880031

510(k) Number K880031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date March 17, 1988
Days to Decision 72 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
30d faster than avg
Panel avg: 102d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

LJP Device Classification - Class 1, General Controls

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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 - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 30
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K880031.
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · Diagnostic Products Corp. · Feb 1990
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · Whittaker Bioproducts, Inc. · Oct 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988
MODIFIED CHLAMYSET ANTIGEN
K872744 · Orion Corp. · Sep 1987
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
K864128 · Diagnostic Technology, Inc. · Apr 1987