Cleared Traditional

K892371 - CHLAMYDIAZYME BLOCKING REAGENT

K892371 is an FDA 510(k) clearance for CHLAMYDIAZYME BLOCKING REAGENT, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K892371 · Abbott Laboratories · Microbiology device
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Jun 1989
Decision
57d
Days
Class 1
Risk

K892371 is an FDA 510(k) clearance for the CHLAMYDIAZYME BLOCKING REAGENT. 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 June 2, 1989 after a review of 57 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

FDA 510(k) Submission Details - K892371

510(k) Number K892371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date June 02, 1989
Days to Decision 57 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
45d faster than avg
Panel avg: 102d · This submission: 57d
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 46
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K892371.
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · Eastman Kodak Company · Jan 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · Ciba Corning Diagnostics Corp. · Oct 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · Abbott Laboratories · Jul 1989
MICROTRAK CHLAMYDIA EIA
K890196 · Syva Co. · Mar 1989
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · Abbott Laboratories · Dec 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1988