Cleared Traditional

K861697 - SELF ASSURE/GHB (CAPILLARY-BLOOD COLLEC...

K861697 is an FDA 510(k) clearance for SELF ASSURE/GHB (CAPILLARY-BLOOD COLLEC..., manufactured by Awareness Technology, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K861697 · Awareness Technology, Inc. · Hematology device
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Aug 1986
Decision
106d
Days
Class 2
Risk

K861697 is an FDA 510(k) clearance for the SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT). Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 106 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 Awareness Technology, Inc. devices

FDA 510(k) Submission Details - K861697

510(k) Number K861697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1986
Decision Date August 19, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
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 167
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K861697.
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643 · Pacific Hemostasis · Apr 1987
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · Sandare Chemical Co., Inc. · Aug 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985