Cleared Traditional

K853401 - CHLAMYSET ANTIGEN

K853401 is an FDA 510(k) clearance for CHLAMYSET ANTIGEN, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code LJP cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K853401 · Orion Corp. · Microbiology device
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Apr 1986
Decision
259d
Days
Class 1
Risk

K853401 is an FDA 510(k) clearance for the CHLAMYSET ANTIGEN. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on April 28, 1986 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orion Corp. devices

FDA 510(k) Submission Details - K853401

510(k) Number K853401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date April 28, 1986
Days to Decision 259 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
157d slower than avg
Panel avg: 102d · This submission: 259d
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 K853401.
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · American Micro Scan · Dec 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc. · Dec 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · Difco Laboratories, Inc. · Aug 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179 · Difco Laboratories, Inc. · Mar 1986
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc. · Dec 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985