Cleared Traditional

K912085 - ACLAIMS-IS (FDA 510(k) Clearance)

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

K912085 · W-Technology · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
171d
Days
Class 2
Risk

K912085 is an FDA 510(k) clearance for the ACLAIMS-IS. Classified as Analyzer, Chromosome, Automated (product code LNJ), Class II - Special Controls.

Submitted by W-Technology (Carmichael, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 171 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 W-Technology devices

Submission Details

510(k) Number K912085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date October 31, 1991
Days to Decision 171 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
94d slower than avg
Panel avg: 77d · This submission: 171d
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.