Cleared Traditional

K940089 - CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE

K940089 is the FDA 510(k) clearance for CBC-COBAS 5 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 74-day FDA review.

K940089 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
74d
Days
Class 2
Risk

K940089 is an FDA 510(k) clearance for the CBC-COBAS 5 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 March 22, 1994 after a review of 74 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 K940089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1994
Decision Date March 22, 1994
Days to Decision 74 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
39d faster than avg
Panel avg: 113d · This submission: 74d
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 K940089.
COULTER FLOW SET
K944751 · Coulter Corp. · Dec 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K942822 · R&D Systems, Inc. · Oct 1994
PARA 5 DIFF
K935196 · Streck Laboratories, Inc. · Apr 1994
SE-CHECK
K940181 · Streck Laboratories, Inc. · Mar 1994
CHECKPOINT
K931947 · Medical Specialties, Inc. · Jun 1993
COULTER RETIC-C CELL CONTROL
K930119 · Coulter Electronics, Inc. · Apr 1993