Cleared Traditional

K901635 - RUBELLA IGG ELISA TEST

K901635 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 80-day FDA review.

K901635 · Gull Laboratories, Inc. · Microbiology device
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Jun 1990
Decision
80d
Days
Class 2
Risk

K901635 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 June 28, 1990 after a review of 80 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 Gull Laboratories, Inc. devices

Submission Details

510(k) Number K901635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date June 28, 1990
Days to Decision 80 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
22d faster than avg
Panel avg: 102d · This submission: 80d
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 K901635.
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
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · Ortho Diagnostic Systems, Inc. · Dec 1989
PLATELIA RUBELLA IGG KIT
K894946 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
K892202 · Gull Laboratories, Inc. · Sep 1989