Cleared Traditional

K904854 - RUBEOLA IGG ELISA TEST

K904854 is an FDA 510(k) clearance for RUBEOLA IGG ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LJB cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K904854 · Gull Laboratories, Inc. · Microbiology device
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Dec 1990
Decision
36d
Days
Class 1
Risk

K904854 is an FDA 510(k) clearance for the RUBEOLA IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 1990 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - 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

FDA 510(k) Submission Details - K904854

510(k) Number K904854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date December 04, 1990
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

LJB Device Classification - Class 1, General Controls

Product Code LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
Definition The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

All 8
Devices cleared under the same product code (LJB) and FDA review panel - the closest regulatory comparables to K904854.
BARTELS RUBEOLA IGM EIA
K922335 · Baxter Diagnostics, Inc. · Sep 1992
RUBEOLA IGM ELISA TEST
K904083 · Gull Laboratories, Inc. · Jan 1991
MEASLES IGG MICROASSAY
K903961 · Diamedix Corp. · Dec 1990
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · Clinical Sciences, Inc. · Jun 1989
VIRGO(TM) MEASLES IGG ELISA
K873925 · Electro-Nucleonics Laboratories, Inc. · Feb 1988