Cleared Traditional

K811000 - ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL

K811000 is the FDA 510(k) clearance for ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL by Corning Medical & Scientific. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811000 · Corning Medical & Scientific · Hematology device
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May 1981
Decision
25d
Days
Class 2
Risk

K811000 is an FDA 510(k) clearance for the ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 25 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K811000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1981
Decision Date May 08, 1981
Days to Decision 25 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
88d faster than avg
Panel avg: 113d · This submission: 25d
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 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K811000.
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710 · Bio-Rad · Jul 1981
LANCER GLYCOSYLATED HEMOGLOBIN
K810638 · Sherwood Medical Co. · May 1981
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
K810714 · Sherwood Medical Co. · May 1981
GLYCOHEMOGLOBIN IN WHOLE BLOOD
K802721 · Sigma Chemical Co. · Dec 1980
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
K802233 · Helena Laboratories · Oct 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857 · Helena Laboratories · Sep 1980