Cleared Traditional

K904084 - RUBELLA IGM ELISA TEST

K904084 is an FDA 510(k) clearance for RUBELLA IGM ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904084 · Gull Laboratories, Inc. · Microbiology device
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Dec 1990
Decision
90d
Days
Class 2
Risk

K904084 is an FDA 510(k) clearance for the RUBELLA IGM ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 1990 after a review of 90 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K904084

510(k) Number K904084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date December 04, 1990
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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 79
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K904084.
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
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · Ortho Diagnostic Systems, Inc. · Dec 1990
MODIFICATION OF SEROCARD RUBELLA IGG TEST
K902571 · Disease Detection International, Inc. · Sep 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · Vitek Systems, Inc. · Aug 1990