Cleared Traditional

K111128 - LABONACHECK A1C

K111128 is an FDA 510(k) clearance for LABONACHECK A1C, manufactured by Ceragem International, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K111128 · Ceragem International, Inc. · Chemistry device
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Sep 2012
Decision
511d
Days
Class 2
Risk

K111128 is an FDA 510(k) clearance for the LABONACHECK A1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ceragem International, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ceragem International, Inc. devices

FDA 510(k) Submission Details - K111128

510(k) Number K111128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date September 13, 2012
Days to Decision 511 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
423d slower than avg
Panel avg: 88d · This submission: 511d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 169
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K111128.
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842 · Axis-Shield Diagnostics, Ltd. · Dec 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
K122101 · Sebia · Dec 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · Beckman Coulter, Inc. · Oct 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012
HEMOCUE HBA1C 501
K121366 · Infopia Co, Ltd. · Sep 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
K113437 · Alfa Wassermann Diagnostic Technologies, Inc. · Aug 2012