Cleared Traditional

K870946 - MONABRITE CHLAMYDIA TRACHOMATIS DIR. SP...

K870946 is the FDA 510(k) clearance for MONABRITE CHLAMYDIA TRACHOMATIS DIR. SP... by Serono Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K870946 · Serono Diagnostics, Inc. · Microbiology device
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Apr 1987
Decision
51d
Days
Class 1
Risk

K870946 is an FDA 510(k) clearance for the MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on April 29, 1987 after a review of 51 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K870946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1987
Decision Date April 29, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
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 - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 17
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K870946.
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
K880031 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1987
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc. · Dec 1986