Cleared Traditional

K810638 - LANCER GLYCOSYLATED HEMOGLOBIN

K810638 is an FDA 510(k) clearance for LANCER GLYCOSYLATED HEMOGLOBIN, manufactured by Sherwood Medical Co.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K810638 · Sherwood Medical Co. · Hematology device
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May 1981
Decision
59d
Days
Class 2
Risk

K810638 is an FDA 510(k) clearance for the LANCER GLYCOSYLATED HEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 59 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K810638

510(k) Number K810638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1981
Decision Date May 08, 1981
Days to Decision 59 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
54d faster than avg
Panel avg: 113d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K810638.
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
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
K810714 · Sherwood Medical Co. · May 1981
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL
K811000 · Corning Medical & Scientific · May 1981
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K802832 · Sandare Chemical Co., Inc. · Jan 1981