Cleared Traditional

K821360 - GLYCO-GEL TEST KIT

K821360 is the FDA 510(k) clearance for GLYCO-GEL TEST KIT by Pierce Chemical Co.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K821360 · Pierce Chemical Co. · Hematology device
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Jun 1982
Decision
26d
Days
Class 2
Risk

K821360 is an FDA 510(k) clearance for the GLYCO-GEL TEST KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Pierce Chemical Co. (Walker, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 26 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 Pierce Chemical Co. devices

Submission Details

510(k) Number K821360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1982
Decision Date June 02, 1982
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
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 143
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K821360.
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · Isolab, Inc. · Dec 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977 · Bio-Rad · Nov 1982
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · Ortho Diagnostic Systems, Inc. · Sep 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242 · Cordis Corp. · Sep 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710 · Bio-Rad · Jul 1981