Cleared Traditional

K133344 - MINICAP HB A1C

K133344 is the FDA 510(k) clearance for MINICAP HB A1C by Sebia. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K133344 · Sebia · Chemistry device
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Mar 2014
Decision
149d
Days
Class 2
Risk

K133344 is an FDA 510(k) clearance for the MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPI.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on March 28, 2014 after a review of 149 days - within the typical 510(k) review window.

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

View all Sebia devices

Submission Details

510(k) Number K133344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2013
Decision Date March 28, 2014
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
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 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K133344.
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
K133803 · Diazyme Laboratories · Aug 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · Beckman Coulter, Inc. · Jul 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · Bio-Rad Laboratories, Inc. · Jun 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · Beckman Coulter, Inc. · Oct 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012