Cleared Traditional

K844928 - QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE

K844928 is an FDA 510(k) clearance for QUANTICEL HHR TWO HUMAN HEMATOLOGY REFE..., manufactured by Bhp Diagnostix, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K844928 · Bhp Diagnostix, Inc. · Hematology device
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Mar 1985
Decision
93d
Days
Class 2
Risk

K844928 is an FDA 510(k) clearance for the QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bhp Diagnostix, Inc. (West Chester, US). The FDA issued a Cleared decision on March 22, 1985 after a review of 93 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 Bhp Diagnostix, Inc. devices

FDA 510(k) Submission Details - K844928

510(k) Number K844928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1984
Decision Date March 22, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K844928.
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
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · Coulter Electronics, Inc. · Dec 1984
COUNT-A-PART PLUS
K841809 · Diagnostic Technology, Inc. · Nov 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · R&D Systems, Inc. · Nov 1984