Cleared Traditional

K872145 - CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)

K872145 is an FDA 510(k) clearance for CELLSOFT(TM)-CASA (SERIES 1000, manufactured by Cryo Corp.. The device is a Class 2 Pathology device with product code GKL cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K872145 · Cryo Corp. · Pathology device
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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.

FDA 510(k) Submission Details - K872145

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
84d slower than avg
Panel avg: 78d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 102
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