Cleared Traditional

K912391 - RUBALEX, MODIFICATION

K912391 is an FDA 510(k) clearance for RUBALEX, manufactured by Orion Corp.. The device is a Class 2 Microbiology device with product code LQN cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K912391 · Orion Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
346d
Days
Class 2
Risk

K912391 is an FDA 510(k) clearance for the RUBALEX, MODIFICATION. Classified as Latex Agglutination Assay, Rubella (product code LQN), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on May 4, 1992 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Orion Corp. devices

FDA 510(k) Submission Details - K912391

510(k) Number K912391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date May 04, 1992
Days to Decision 346 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 102d · This submission: 346d
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

Devices cleared under the same product code (LQN) and FDA review panel - the closest regulatory comparables to K912391.
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc. · Jan 1996
RESUBMITTED MODIFIED RUBALEX
K901637 · Orion Corp. · Apr 1990
RUBALEX (REVISED VERSION)
K861881 · Orion Corp. · Jun 1986
RUBALEX
K852788 · Orion Corp. · Mar 1986
VIROGEN RUBELLA MICROTITER TEST
K844436 · Armkel, LLC · May 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · Armkel, LLC · May 1985