Cleared Traditional

K954137 - QBC CENTRIFUGAL HEMATOLOGY CONTROL

K954137 is the FDA 510(k) clearance for QBC CENTRIFUGAL HEMATOLOGY CONTROL by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K954137 · R&D Systems, Inc. · Hematology device
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Oct 1995
Decision
35d
Days
Class 2
Risk

K954137 is an FDA 510(k) clearance for the QBC CENTRIFUGAL HEMATOLOGY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 35 days - a notably fast clearance cycle.

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: 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 R&D Systems, Inc. devices

Submission Details

510(k) Number K954137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date October 06, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
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 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K954137.
CALIBRATION VERIFICATION ASSESSMENT (CVA)
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4C PLUS COULTER CELL CONTROL
K955016 · Coulter Corp. · Jan 1996
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · Aalto Scientific, Ltd. · Sep 1995
SF-CHECK
K952245 · Streck Laboratories, Inc. · Sep 1995
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · R&D Systems, Inc. · Dec 1994