Cleared Traditional

K982786 - TRACCELL 2000 SLIDE MAPPING SYSTEM

K982786 is the FDA 510(k) clearance for TRACCELL 2000 SLIDE MAPPING SYSTEM by Accumed Intl., Inc.. It is a Class 2 Hematology device (product code JOY) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K982786 · Accumed Intl., Inc. · Hematology device
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Oct 1998
Decision
67d
Days
Class 2
Risk

K982786 is an FDA 510(k) clearance for the TRACCELL 2000 SLIDE MAPPING SYSTEM. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Accumed Intl., Inc. (Chicago, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accumed Intl., Inc. devices

Submission Details

510(k) Number K982786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date October 16, 1998
Days to Decision 67 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOY Device, Automated Cell-locating
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 Hematology devices follow this clearance model.

Regulatory Peers - JOY Device, Automated Cell-locating

All 8
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K982786.
X100 with Full Field Peripheral Blood Smear (PBS) Application
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EASYCELL CELL LOCATOR
K092116 · Medica Corp. · May 2010
SCANNING SYS., AUTO. COMP., ACS1000
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