Cleared Traditional

K864664 - H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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.