Cleared Traditional

K120199 - GLYCOSYLATED HEMOGLOBIN ASSAY

Also marketed or referenced as:
CLINICAL CHEMISTRY

K120199 is an FDA 510(k) clearance for GLYCOSYLATED HEMOGLOBIN ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K120199 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
263d
Days
Class 2
Risk

K120199 is an FDA 510(k) clearance for the GLYCOSYLATED HEMOGLOBIN ASSAY. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 263 days - an extended review cycle.

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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K120199

510(k) Number K120199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date October 12, 2012
Days to Decision 263 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 88d · This submission: 263d
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 189
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K120199.
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
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · Oct 2012
LABONACHECK A1C
K111128 · Ceragem International, Inc. · Sep 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012
HEMOCUE HBA1C 501
K121366 · Infopia Co, Ltd. · Sep 2012