Cleared Traditional

K862186 - LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II (FDA 510(k) Clearance)

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

K862186 · Bio-Rad · Hematology device
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Jul 1986
Decision
22d
Days
Class 2
Risk

K862186 is an FDA 510(k) clearance for the LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 22 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.

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Submission Details

510(k) Number K862186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date July 01, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
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.