Cleared Traditional

ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG (K895468) - FDA 510(k) Clearance

Class I Microbiology device.

K895468 · Orgenics, Ltd. · Microbiology device
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Mar 1990
Decision
183d
Days
Class 1
Risk

K895468 is an FDA 510(k) clearance for the ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Orgenics, Ltd. (Columbia, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 183 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 Orgenics, Ltd. devices

Submission Details

510(k) Number K895468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date March 13, 1990
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 102d · This submission: 183d
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.

Regulatory Peers - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K895468.
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