Cleared Traditional

ALBICANS SURE (K913426) - FDA 510(k) Clearance

Class I Microbiology device.

K913426 · Jrga Diagnostics · Microbiology device
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Apr 1992
Decision
265d
Days
Class 1
Risk

K913426 is an FDA 510(k) clearance for the ALBICANS SURE. Classified as Kit, Screening, Yeast (product code JXC), Class I - General Controls.

Submitted by Jrga Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 265 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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.

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Submission Details

510(k) Number K913426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1991
Decision Date April 22, 1992
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 102d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXC Kit, Screening, Yeast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.