Cleared Traditional

K893755 - RUBAGEN

K893755 is an FDA 510(k) clearance for RUBAGEN, manufactured by Biokit USA, Inc.. The device is a Class 2 Microbiology device with product code LQN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K893755 · Biokit USA, Inc. · Microbiology device
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Aug 1989
Decision
94d
Days
Class 2
Risk

K893755 is an FDA 510(k) clearance for the RUBAGEN. Classified as Latex Agglutination Assay, Rubella (product code LQN), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on August 21, 1989 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Biokit USA, Inc. devices

FDA 510(k) Submission Details - K893755

510(k) Number K893755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date August 21, 1989
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
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 K893755.
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc. · Jan 1996
RUBALEX, MODIFICATION
K912391 · Orion Corp. · May 1992
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