Cleared Traditional

K880824 - PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT

K880824 is an FDA 510(k) clearance for PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT, manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K880824 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Apr 1988
Decision
42d
Days
Class 1
Risk

K880824 is an FDA 510(k) clearance for the PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 42 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 - K880824

510(k) Number K880824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date April 12, 1988
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

LJC Device Classification - Class 1, General Controls

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
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 - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 52
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K880824.
ABBOTT TESTPACK CHLAMYDIA
K880783 · Abbott Laboratories · Jul 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · Abbott Laboratories · Jul 1988
CHLAMYDIAZYME(TM)
K880469 · Abbott Laboratories · May 1988
CHLAMYSET ANTIBODY EIA
K864457 · Orion Corp. · Sep 1987
VIVID CHLAMYDIA(TM)
K872148 · Seragen Diagnostics, Inc. · Aug 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · Boots-Celltech Diagnostics, Inc. · Jun 1987