Cleared Traditional

K914028 - RUBELLA IGM ELISA TEST SYSTEM

K914028 is an FDA 510(k) clearance for RUBELLA IGM ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K914028 · Zeus Scientific, Inc. · Microbiology device
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Apr 1992
Decision
225d
Days
Class 2
Risk

K914028 is an FDA 510(k) clearance for the RUBELLA IGM ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 225 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K914028

510(k) Number K914028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date April 22, 1992
Days to Decision 225 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 102d · This submission: 225d
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 63
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K914028.
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · Abbott Laboratories · Dec 1994
BARTELS RUBELLA IGM EIA
K922581 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBELLA IGG EIA
K922586 · Baxter Diagnostics, Inc. · Sep 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