Cleared Traditional

K895095 - AKS II

K895095 is an FDA 510(k) clearance for AKS II, manufactured by Amoco Technology Co.. The device is a Class 2 Pathology device with product code LNJ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

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

FDA 510(k) Submission Details - K895095

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.

LNJ Device Classification - Class 2, Special Controls

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.