Cleared Traditional

ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL (K882535) - FDA 510(k) Clearance

Class I Microbiology device.

K882535 · Abbott Laboratories · Microbiology device
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Jul 1988
Decision
23d
Days
Class 1
Risk

K882535 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL. 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 14, 1988 after a review of 23 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 Abbott Laboratories devices

Submission Details

510(k) Number K882535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date July 14, 1988
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
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 K882535.
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · Eastman Kodak Company · Nov 1988
PHARMACIA CHLAMYDIA EIA
K882676 · Pharmacia, Inc. · Aug 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · Abbott Laboratories · Jul 1988
CHLAMYDIAZYME(TM)
K880469 · Abbott Laboratories · May 1988
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · Abbott Laboratories · Apr 1987
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490 · Ortho Diagnostic Systems, Inc. · Nov 1986