Cleared Traditional

ABBOTT TESTPACK CHLAMYDIA (K880783) - FDA 510(k) Clearance

Class I Microbiology device.

K880783 · Abbott Laboratories · Microbiology device
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Jul 1988
Decision
150d
Days
Class 1
Risk

K880783 is an FDA 510(k) clearance for the ABBOTT TESTPACK CHLAMYDIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 25, 1988 after a review of 150 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 Abbott Laboratories devices

Submission Details

510(k) Number K880783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date July 25, 1988
Days to Decision 150 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
48d slower than avg
Panel avg: 102d · This submission: 150d
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 29
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K880783.
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · Abbott Laboratories · Dec 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · Eastman Kodak Company · Nov 1988
PHARMACIA CHLAMYDIA EIA
K882676 · Pharmacia, Inc. · Aug 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · Abbott Laboratories · Jul 1988
CHLAMYDIAZYME(TM)
K880469 · Abbott Laboratories · May 1988
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · Abbott Laboratories · Apr 1987