Cleared Traditional

K911393 - RUBENOSTIKA IGG MICROELISA SYSTEM

K911393 is an FDA 510(k) clearance for RUBENOSTIKA IGG MICROELISA SYSTEM, manufactured by Organon Teknika Corp.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K911393 · Organon Teknika Corp. · Microbiology device
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Apr 1991
Decision
31d
Days
Class 2
Risk

K911393 is an FDA 510(k) clearance for the RUBENOSTIKA IGG MICROELISA SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 31 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K911393

510(k) Number K911393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date April 29, 1991
Days to Decision 31 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
71d faster than avg
Panel avg: 102d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFX Device Classification - Class 2, Special Controls

Product Code LFX Enzyme Linked Immunoabsorbent 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 - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 65
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K911393.
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc. · Apr 1992
RUBELLA IGG ELISA TEST
K915893 · Gull Laboratories, Inc. · Mar 1992
ELISA RUBELLA IGM
K914420 · Sclavo, Inc. · Dec 1991
RUBELLA IGM ELISA TEST
K904084 · Gull Laboratories, Inc. · Dec 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · Ortho Diagnostic Systems, Inc. · Dec 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · Vitek Systems, Inc. · Aug 1990