Cleared Traditional

K862371 - HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)

K862371 is the FDA 510(k) clearance for HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) by Bio-Rad. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K862371 · Bio-Rad · Hematology device
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Sep 1986
Decision
84d
Days
Class 2
Risk

K862371 is an FDA 510(k) clearance for the HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C). Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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 Bio-Rad devices

Submission Details

510(k) Number K862371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date September 16, 1986
Days to Decision 84 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
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K862371.
GLYCO-PROBE GSP
K873428 · Isolab, Inc. · Apr 1988
FRUCTOSAMINE TEST (ROCHE)
K854010 · Roche Diagnostic Systems, Inc. · Dec 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985
GLYCO-TEK AFFINITY COLUMN
K842689 · Helena Laboratories · Oct 1984