Cleared Traditional

K802432 - GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.

K802432 is the FDA 510(k) clearance for GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. by Clin Tech Diagnostics Corp.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K802432 · Clin Tech Diagnostics Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
56d
Days
Class 2
Risk

K802432 is an FDA 510(k) clearance for the GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Clin Tech Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 56 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 Clin Tech Diagnostics Corp. devices

Submission Details

510(k) Number K802432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1980
Decision Date December 01, 1980
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
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 144
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K802432.
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
K810714 · Sherwood Medical Co. · May 1981
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL
K811000 · Corning Medical & Scientific · 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
GLYCOSYLATED HEMOGLOBIN KIT
K801561 · Amersham Corp. · Aug 1980