Cleared Traditional

K851375 - TRI-COUNT

K851375 is an FDA 510(k) clearance for TRI-COUNT, manufactured by Hematology Marketing Assoc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851375 · Hematology Marketing Assoc. · Hematology device
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Jul 1985
Decision
95d
Days
Class 2
Risk

K851375 is an FDA 510(k) clearance for the TRI-COUNT. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hematology Marketing Assoc. devices

FDA 510(k) Submission Details - K851375

510(k) Number K851375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1985
Decision Date July 12, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 167
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K851375.
MSI-HB HEMOGLOBIN CONTROL
K853776 · Medical Specialties, Inc. · Sep 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · Abbott Diagnostics · Sep 1985
QUICK-COUNT HEMATOLOGY CONTROLS
K851663 · Seragen Diagnostics, Inc. · Jul 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · R&D Systems, Inc. · May 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · Technicon Instruments Corp. · Apr 1985
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K844927 · Bhp Diagnostix, Inc. · Mar 1985