Cleared Traditional

K862186 - LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLO...

K862186 is the FDA 510(k) clearance for LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLO... by Bio-Rad. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

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 K862186.
MSI HEMATOLOGY CONTROL +
K871067 · Medical Specialties, Inc. · Mar 1987
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K863224 · Fisher Scientific Co., LLC · Oct 1986
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
K862318 · Fisher Scientific Co., LLC · Jul 1986
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · Bio/Data Corp. · Mar 1986
PLATELET-TROL II
K854353 · R&D Systems, Inc. · Nov 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · Streck Laboratories, Inc. · Oct 1985