Cleared Traditional

K874749 - BINAX EQUATE GLYCOHEMOGLOBIN

K874749 is an FDA 510(k) clearance for BINAX EQUATE GLYCOHEMOGLOBIN, manufactured by Binax, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K874749

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
Combination Product No
PCCP Authorized No
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.

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 193
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