Cleared Traditional

K803186 - NORMAL AND ELEVATED CONTROL FOR GLYCO.

K803186 is the FDA 510(k) clearance for NORMAL AND ELEVATED CONTROL FOR GLYCO. by Applied Clinical Research Laboratories. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K803186 · Applied Clinical Research Laboratories · Chemistry device

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Jan 1981

Decision

36d

Days

Class 2

Risk

K803186 is an FDA 510(k) clearance for the NORMAL AND ELEVATED CONTROL FOR GLYCO.. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Applied Clinical Research Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Applied Clinical Research Laboratories devices

Submission Details

510(k) Number	K803186 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 1980
Decision Date	January 21, 1981
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

52d faster than avg

Panel avg: 88d · This submission: 36d

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 Chemistry 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 K803186.

LANCER GLYCOSYLATED HEMOGLOBIN

K810638 · Sherwood Medical Co. · May 1981

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K803186

Applied Clinical Research Laboratories

Mchenry, IL · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Chemistry

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