Cleared Traditional

K822977 - HEMOGLOBIN ALC BY COLUMN TEST

K822977 is the FDA 510(k) clearance for HEMOGLOBIN ALC BY COLUMN TEST by Bio-Rad. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K822977 · Bio-Rad · Hematology device
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Nov 1982
Decision
39d
Days
Class 2
Risk

K822977 is an FDA 510(k) clearance for the HEMOGLOBIN ALC BY COLUMN TEST. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 39 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 Bio-Rad devices

Submission Details

510(k) Number K822977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1982
Decision Date November 16, 1982
Days to Decision 39 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
74d faster than avg
Panel avg: 113d · This submission: 39d
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 K822977.
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · Bio-Rad · Jun 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · Isolab, Inc. · Dec 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