Cleared Traditional

K895095 - AKS II (FDA 510(k) Clearance)

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

K895095 · Amoco Technology Co. · Pathology device
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Feb 1990
Decision
179d
Days
Class 2
Risk

K895095 is an FDA 510(k) clearance for the AKS II. Classified as Analyzer, Chromosome, Automated (product code LNJ), Class II - Special Controls.

Submitted by Amoco Technology Co. (Naperville, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 179 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5260 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amoco Technology Co. devices

Submission Details

510(k) Number K895095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1989
Decision Date February 09, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 77d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNJ Analyzer, Chromosome, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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.