Cleared Traditional

K881109 - SPIROCHETES HISTOLOGY CONTROL SLIDES (FDA 510(k) Clearance)

Class I Microbiology device.

K881109 · Sigma Diagnostics, Inc. · Microbiology device
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Apr 1988
Decision
37d
Days
Class 1
Risk

K881109 is an FDA 510(k) clearance for the SPIROCHETES HISTOLOGY CONTROL SLIDES. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 37 days - a notably fast clearance 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: 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K881109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date April 21, 1988
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJG Quality Control Slides
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.