Cleared Traditional

K874749 - BINAX EQUATE GLYCOHEMOGLOBIN

K874749 is the FDA 510(k) clearance for BINAX EQUATE GLYCOHEMOGLOBIN by Binax, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K874749 · Binax, Inc. · Hematology device
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Aug 1988
Decision
268d
Days
Class 2
Risk

K874749 is an FDA 510(k) clearance for the BINAX EQUATE GLYCOHEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on August 12, 1988 after a review of 268 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 Binax, Inc. devices

Submission Details

510(k) Number K874749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date August 12, 1988
Days to Decision 268 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 113d · This submission: 268d
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 126
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K874749.
LABILE LYSING REAGENT
K884315 · Helena Laboratories · Dec 1988
GHB SAMPLE PAPER
K880673 · Isolab, Inc. · Nov 1988
REP GLYCO SYSTEM
K881863 · Helena Laboratories · Sep 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · Bio-Rad · Aug 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · Helena Laboratories · May 1988