Cleared Traditional

K911444 - RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM

K911444 is an FDA 510(k) clearance for RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM, manufactured by Wampole Laboratories. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K911444 · Wampole Laboratories · Microbiology device
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Aug 1991
Decision
151d
Days
Class 2
Risk

K911444 is an FDA 510(k) clearance for the RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on August 30, 1991 after a review of 151 days - an extended review 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: 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 Wampole Laboratories devices

FDA 510(k) Submission Details - K911444

510(k) Number K911444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date August 30, 1991
Days to Decision 151 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 102d · This submission: 151d
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 80
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K911444.
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
RUBENOSTIKA IGG MICROELISA SYSTEM
K911393 · Organon Teknika Corp. · Apr 1991
RUBELLA IGM ELISA TEST
K904084 · Gull Laboratories, Inc. · Dec 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · Ortho Diagnostic Systems, Inc. · Dec 1990