Cleared Traditional

K864643 - GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASS...

K864643 is the FDA 510(k) clearance for GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASS... by Pacific Hemostasis. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K864643 · Pacific Hemostasis · Hematology device
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Apr 1987
Decision
153d
Days
Class 2
Risk

K864643 is an FDA 510(k) clearance for the GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on April 28, 1987 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pacific Hemostasis devices

Submission Details

510(k) Number K864643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1986
Decision Date April 28, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 113d · This submission: 153d
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 140
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K864643.
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
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985