Cleared Traditional

K861697 - SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 248
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K861697.
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