Cleared Traditional

K012138 - MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

K012138 is an FDA 510(k) clearance for MODIFICATION TO ACIS (AUTOMATED CELLULA..., manufactured by Chroma Vision Medical Systems, Inc.. The device is a Class 2 Pathology device with product code MYA cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K012138 · Chroma Vision Medical Systems, Inc. · Pathology device
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Sep 2002
Decision
447d
Days
Class 2
Risk

K012138 is an FDA 510(k) clearance for the MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM). Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Chroma Vision Medical Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 30, 2002 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology 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 Pathology submissions.

View all Chroma Vision Medical Systems, Inc. devices

FDA 510(k) Submission Details - K012138

510(k) Number K012138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2001
Decision Date September 30, 2002
Days to Decision 447 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
370d slower than avg
Panel avg: 77d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYA Device Classification - Class 2, Special Controls

Product Code MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
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 Pathology devices follow this clearance model.

Regulatory Peers - MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

All 7
Devices cleared under the same product code (MYA) and FDA review panel - the closest regulatory comparables to K012138.
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · Leica Biosystems Newcastle, Ltd. · May 2014
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · Dako North America, Inc. · Feb 2013
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc. · Dec 2012
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp. · Mar 2000
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · Ventana, Inc. · Aug 1999