Cleared Traditional

K872145 - CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) (FDA 510(k) Clearance)

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

K872145 · Cryo Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
162d
Days
Class 2
Risk

K872145 is an FDA 510(k) clearance for the CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000). Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Cryo Corp. (Washington, US). The FDA issued a Cleared decision on November 13, 1987 after a review of 162 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5200 - 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 Cryo Corp. devices

Submission Details

510(k) Number K872145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1987
Decision Date November 13, 1987
Days to Decision 162 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 77d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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.