Cleared Traditional

VIRGO(TM) MEASLES IGG ELISA (K873925) - FDA 510(k) Clearance

Class I Microbiology device.

K873925 · Electro-Nucleonics Laboratories, Inc. · Microbiology device
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Feb 1988
Decision
152d
Days
Class 1
Risk

K873925 is an FDA 510(k) clearance for the VIRGO(TM) MEASLES IGG ELISA. Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on February 24, 1988 after a review of 152 days - an extended review 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: 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 Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K873925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date February 24, 1988
Days to Decision 152 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 102d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.