Cleared Traditional

K862948 - CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)

K862948 is an FDA 510(k) clearance for CHLAMYDIA TISSUE CULTURE CONFIRMATION T..., manufactured by Intercare Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K862948 · Intercare Diagnostics, Inc. · Microbiology device
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Oct 1986
Decision
73d
Days
Class 1
Risk

K862948 is an FDA 510(k) clearance for the CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA). Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Intercare Diagnostics, Inc. (Berkeley, US). The FDA issued a Cleared decision on October 17, 1986 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intercare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K862948

510(k) Number K862948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date October 17, 1986
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
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 K862948.
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
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K863490 · Ortho Diagnostic Systems, Inc. · Nov 1986
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K862638 · Isolab, Inc. · Aug 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966 · Boots-Celltech Diagnostics, Inc. · Aug 1986
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962 · Abbott Laboratories · Oct 1983