Cleared Traditional

K903961 - MEASLES IGG MICROASSAY

K903961 is an FDA 510(k) clearance for MEASLES IGG MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 1 Microbiology device with product code LJB cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K903961 · Diamedix Corp. · Microbiology device
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Dec 1990
Decision
122d
Days
Class 1
Risk

K903961 is an FDA 510(k) clearance for the MEASLES IGG MICROASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 122 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K903961

510(k) Number K903961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 28, 1990
Days to Decision 122 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
20d slower than avg
Panel avg: 102d · This submission: 122d
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 K903961.
BARTELS RUBEOLA IGG EIA
K922330 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBEOLA IGM EIA
K922335 · Baxter Diagnostics, Inc. · Sep 1992
RUBEOLA IGM ELISA TEST
K904083 · Gull Laboratories, Inc. · Jan 1991
RUBEOLA IGG ELISA TEST
K904854 · Gull Laboratories, Inc. · 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