Cleared Traditional

K913618 - ARBOVIRUS IGM IFA TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K913618 · Hillcrest Biologicals · Microbiology device
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Dec 1992
Decision
478d
Days
Class 1
Risk

K913618 is an FDA 510(k) clearance for the ARBOVIRUS IGM IFA TEST. Classified as Antisera, Cf, Equine Encephalitis Virus, Eee, Wee (product code GQC), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3240 - 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 Hillcrest Biologicals devices

Submission Details

510(k) Number K913618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date December 03, 1992
Days to Decision 478 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 102d · This submission: 478d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3240
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.