Cleared Traditional

K881111 - INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL

K881111 is an FDA 510(k) clearance for INTRACELLULAR/EXTRACELLULAR IRON HISTOL..., manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K881111 · Sigma Diagnostics, Inc. · Microbiology device
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Mar 1988
Decision
15d
Days
Class 1
Risk

K881111 is an FDA 510(k) clearance for the INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL. 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 March 30, 1988 after a review of 15 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

FDA 510(k) Submission Details - K881111

510(k) Number K881111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date March 30, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

LJG Device Classification - Class 1, General Controls

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.

Regulatory Peers - LJG Quality Control Slides

All 17
Devices cleared under the same product code (LJG) and FDA review panel - the closest regulatory comparables to K881111.
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · Sigma Diagnostics, Inc. · Apr 1988
ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES
K880962 · Alpha-Tec Systems, Inc. · Mar 1988
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
K881107 · Sigma Diagnostics, Inc. · Mar 1988
ACID FAST BACILLI STAIN CONTROL
K840515 · Scientific Device Laboratory, Inc. · Mar 1984
METACHROMATIC GRANULE STAIN CONTROL
K840516 · Scientific Device Laboratory, Inc. · Mar 1984
PROTOZOA STAIN CONTROL
K840517 · Scientific Device Laboratory, Inc. · Mar 1984