Cleared Traditional

K864457 - CHLAMYSET ANTIBODY EIA

K864457 is an FDA 510(k) clearance for CHLAMYSET ANTIBODY EIA, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K864457 · Orion Corp. · Microbiology device
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Sep 1987
Decision
303d
Days
Class 1
Risk

K864457 is an FDA 510(k) clearance for the CHLAMYSET ANTIBODY EIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 11, 1987 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K864457

510(k) Number K864457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date September 11, 1987
Days to Decision 303 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
201d slower than avg
Panel avg: 102d · This submission: 303d
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 51
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K864457.
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · Abbott Laboratories · Jul 1988
CHLAMYDIAZYME(TM)
K880469 · Abbott Laboratories · May 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
K880824 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
VIVID CHLAMYDIA(TM)
K872148 · Seragen Diagnostics, Inc. · Aug 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · Boots-Celltech Diagnostics, Inc. · Jun 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · Abbott Laboratories · Apr 1987