Cleared Traditional

K031490 - RUBELLACOL

K031490 is an FDA 510(k) clearance for RUBELLACOL, manufactured by Immunostics Inc.,. The device is a Class 2 Microbiology device with product code LQN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K031490 · Immunostics Inc., · Microbiology device
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Jul 2003
Decision
65d
Days
Class 2
Risk

K031490 is an FDA 510(k) clearance for the RUBELLACOL. Classified as Latex Agglutination Assay, Rubella (product code LQN), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on July 16, 2003 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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 Immunostics Inc., devices

FDA 510(k) Submission Details - K031490

510(k) Number K031490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2003
Decision Date July 16, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQN Device Classification - Class 2, Special Controls

Product Code LQN Latex Agglutination Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LQN Latex Agglutination Assay, Rubella

All 10
Devices cleared under the same product code (LQN) and FDA review panel - the closest regulatory comparables to K031490.
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931 · Sienna Biotech, Inc. · Apr 1997
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
K961784 · Sienna Biotech, Inc. · Oct 1996
MUREX RUB-EX
K954920 · Murex Diagnostics, Inc. · Aug 1996
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc. · Jan 1996
RUBALEX, MODIFICATION
K912391 · Orion Corp. · May 1992
RESUBMITTED MODIFIED RUBALEX
K901637 · Orion Corp. · Apr 1990