Cleared Traditional

K864664 - H-1 SETPOINT PLATELET AND RBC/WBC CALIB...

K864664 is the FDA 510(k) clearance for H-1 SETPOINT PLATELET AND RBC/WBC CALIB... by Technicon Instruments Corp.. It is a Class 2 Hematology device (product code KSA) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K864664 · Technicon Instruments Corp. · Hematology device
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Feb 1987
Decision
70d
Days
Class 2
Risk

K864664 is an FDA 510(k) clearance for the H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS. Classified as Calibrator For Red-cell And White-cell Counting (product code KSA), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 70 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K864664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date February 06, 1987
Days to Decision 70 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
43d faster than avg
Panel avg: 113d · This submission: 70d
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 K864664.
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · Streck Laboratories, Inc. · Dec 1994
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
CBC-CAL/MULTIPLE
K854823 · R&D Systems, Inc. · Feb 1986
HEMOTOLOGY CALIBRATOR
K813530 · American Dade · Feb 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · Coulter Electronics, Inc. · Feb 1982