Cleared Traditional

K913879 - CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE

K913879 is the FDA 510(k) clearance for CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913879 · R&D Systems, Inc. · Hematology device
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Nov 1991
Decision
90d
Days
Class 2
Risk

K913879 is an FDA 510(k) clearance for the CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE. 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 November 27, 1991 after a review of 90 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 R&D Systems, Inc. devices

Submission Details

510(k) Number K913879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date November 27, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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 K913879.
CHECKPOINT
K931947 · Medical Specialties, Inc. · Jun 1993
COULTER RETIC-C CELL CONTROL
K930119 · Coulter Electronics, Inc. · Apr 1993
QC-CHEX
K923971 · Streck Laboratories, Inc. · Nov 1992
PX COULTER(R) CELL CONTROL
K912133 · Coulter Electronics, Inc. · Jul 1991
RETIC-CHEX
K905524 · Streck Laboratories, Inc. · Feb 1991
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K904637 · R&D Systems, Inc. · Oct 1990