Cleared Traditional

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843286 · Immuno-Mycologics, Inc. · Microbiology device
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Oct 1984
Decision
41d
Days
Class 2
Risk

K843286 is an FDA 510(k) clearance for the EI-CANDIDA ENZYME IMMUNOASSAY EI1001. Classified as Candida Spp., Direct Antigen, Id (product code LRF), Class II - Special Controls.

Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3165 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immuno-Mycologics, Inc. devices

Submission Details

510(k) Number K843286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1984
Decision Date October 01, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRF Candida Spp., Direct Antigen, Id
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3165
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.