Cleared Traditional

K851375 - TRI-COUNT

K851375 is the FDA 510(k) clearance for TRI-COUNT by Hematology Marketing Assoc.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 145
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K851375.
PLATELET-TROL II
K854353 · R&D Systems, Inc. · Nov 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · Streck Laboratories, Inc. · Oct 1985
MSI-HB HEMOGLOBIN CONTROL
K853776 · Medical Specialties, Inc. · Sep 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
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · Coulter Electronics, Inc. · Dec 1984