Cleared Traditional

K822867 - GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY

K822867 is the FDA 510(k) clearance for GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY by Isolab, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K822867 · Isolab, Inc. · Chemistry device
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Dec 1982
Decision
67d
Days
Class 2
Risk

K822867 is an FDA 510(k) clearance for the GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Isolab, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 67 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 Isolab, Inc. devices

Submission Details

510(k) Number K822867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date December 03, 1982
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
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 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K822867.
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478 · Bio-Rad · Jun 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · Bio-Rad · Jun 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983
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