Cleared Traditional

K864457 - CHLAMYSET ANTIBODY EIA (FDA 510(k) Clearance)

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 102d · This submission: 303d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.