Cleared Traditional

K864643 - GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT

K864643 is an FDA 510(k) clearance for GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASS..., manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K864643

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
Combination Product No
PCCP Authorized No
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.

LCP Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K864643.
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852 · Sandare Chemical Co., Inc. · Sep 1987
FOCUS-GHB
K871679 · Awareness Technology, Inc. · Jul 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
K861697 · Awareness Technology, Inc. · Aug 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · Sandare Chemical Co., Inc. · Aug 1986