Cleared Traditional

K811567 - ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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.