Cleared Traditional

K854823 - CBC-CAL/MULTIPLE

K854823 is the FDA 510(k) clearance for CBC-CAL/MULTIPLE by R&D Systems, Inc.. It is a Class 2 Hematology device (product code KSA) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K854823 · R&D Systems, Inc. · Hematology device
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Feb 1986
Decision
72d
Days
Class 2
Risk

K854823 is an FDA 510(k) clearance for the CBC-CAL/MULTIPLE. Classified as Calibrator For Red-cell And White-cell Counting (product code KSA), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 13, 1986 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8185 - 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 K854823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date February 13, 1986
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSA Calibrator For Red-cell And White-cell Counting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8185
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 - KSA Calibrator For Red-cell And White-cell Counting

Devices cleared under the same product code (KSA) and FDA review panel - the closest regulatory comparables to K854823.
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · R&D Systems, Inc. · Jan 1990
TECH-CAL(TM)/MULTIPLE
K881161 · R&D Systems, Inc. · May 1988
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · Technicon Instruments Corp. · Feb 1987
HEMOTOLOGY CALIBRATOR
K813530 · American Dade · Feb 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · Coulter Electronics, Inc. · Feb 1982