Cleared Traditional

K895468 - ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG

K895468 is an FDA 510(k) clearance for ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACH..., manufactured by Orgenics, Ltd.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

FDA 510(k) Submission Details - K895468

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.

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 53
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K895468.
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