Cleared Traditional

K801289 - LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT

K801289 is an FDA 510(k) clearance for LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT, manufactured by Leeco Diagnostics, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K801289 · Leeco Diagnostics, Inc. · Hematology device
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Jun 1980
Decision
31d
Days
Class 2
Risk

K801289 is an FDA 510(k) clearance for the LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Leeco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K801289

510(k) Number K801289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1980
Decision Date June 30, 1980
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K801289.
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857 · Helena Laboratories · Sep 1980
GLYCOSYLATED HEMOGLOBIN KIT
K801561 · Amersham Corp. · Aug 1980
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
K801422 · Sandare Chemical Co., Inc. · Jul 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
K800794 · Isolab, Inc. · Apr 1980
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777 · Corning Medical & Scientific · Nov 1979
A-GENT GLYCOSPEC
K791642 · Abbott Laboratories · Oct 1979