Cleared Traditional

VIRATEST-DIA(TM) MEASLES (RUBEOLA) (K910290) - FDA 510(k) Clearance

Class I Microbiology device.

K910290 · Virus Reference Laboratory, Inc. · Microbiology device
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Mar 1992
Decision
421d
Days
Class 1
Risk

K910290 is an FDA 510(k) clearance for the VIRATEST-DIA(TM) MEASLES (RUBEOLA). Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Virus Reference Laboratory, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Virus Reference Laboratory, Inc. devices

Submission Details

510(k) Number K910290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date March 18, 1992
Days to Decision 421 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 102d · This submission: 421d
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.