Cleared Traditional

K904083 - RUBEOLA IGM ELISA TEST

K904083 is an FDA 510(k) clearance for RUBEOLA IGM 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 120-day FDA review.

K904083 · Gull Laboratories, Inc. · Microbiology device
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Jan 1991
Decision
120d
Days
Class 1
Risk

K904083 is an FDA 510(k) clearance for the RUBEOLA IGM 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 January 3, 1991 after a review of 120 days - within the typical 510(k) review window.

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: 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 - K904083

510(k) Number K904083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date January 03, 1991
Days to Decision 120 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
18d slower than avg
Panel avg: 102d · This submission: 120d
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 K904083.
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · Inova Diagnostics, Inc. · Jul 1997
BARTELS RUBEOLA IGG EIA
K922330 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBEOLA IGM EIA
K922335 · Baxter Diagnostics, Inc. · Sep 1992
MEASLES IGG MICROASSAY
K903961 · Diamedix Corp. · Dec 1990
RUBEOLA IGG ELISA TEST
K904854 · Gull Laboratories, Inc. · Dec 1990
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · Clinical Sciences, Inc. · Jun 1989