Cleared Traditional

FOCUS-GHB (K871679) - FDA 510(k) Clearance

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

K871679 · Awareness Technology, Inc. · Hematology device
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Jul 1987
Decision
90d
Days
Class 2
Risk

K871679 is an FDA 510(k) clearance for the FOCUS-GHB. 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 July 28, 1987 after a review of 90 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 K871679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1987
Decision Date July 28, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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 99
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K871679.
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · Helena Laboratories · May 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
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985