Cleared Traditional

K811567 - ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S

K811567 is an FDA 510(k) clearance for ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K811567 · Ortho Diagnostic Systems, Inc. · Hematology device
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Sep 1981
Decision
104d
Days
Class 2
Risk

K811567 is an FDA 510(k) clearance for the ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K811567

510(k) Number K811567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1981
Decision Date September 16, 1981
Days to Decision 104 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
9d faster than avg
Panel avg: 113d · This submission: 104d
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 K811567.
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · Isolab, Inc. · Dec 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977 · Bio-Rad · Nov 1982
GLYCOHEMOGLOBIN
K810958 · Macomb Chemical Co. · 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
K810638 · Sherwood Medical Co. · May 1981