Cleared Traditional

K941624 - RUBELLA IGG ELISA TEST

K941624 is the FDA 510(k) clearance for RUBELLA IGG ELISA TEST by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 487-day FDA review.

K941624 · Gull Laboratories, Inc. · Microbiology device
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Aug 1995
Decision
487d
Days
Class 2
Risk

K941624 is an FDA 510(k) clearance for the RUBELLA IGG 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 August 4, 1995 after a review of 487 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K941624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date August 04, 1995
Days to Decision 487 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
385d slower than avg
Panel avg: 102d · This submission: 487d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K941624.
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · Abbott Laboratories · May 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · Bayer Corp. · Apr 1996
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc. · Apr 1996
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