Cleared Traditional

K860572 - GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET

K860572 is an FDA 510(k) clearance for GLYCOHEMOGLOBIN, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K860572 · Pointe Scientific, Inc., · Hematology device
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May 1986
Decision
91d
Days
Class 2
Risk

K860572 is an FDA 510(k) clearance for the GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on May 16, 1986 after a review of 91 days - within the typical 510(k) review window.

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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K860572

510(k) Number K860572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date May 16, 1986
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K860572.
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
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985
GLYCO-TEK AFFINITY COLUMN
K842689 · Helena Laboratories · Oct 1984
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · Emd Chemicals, Inc. · Jan 1984