Cleared Traditional

HEMOGLOBIN A1C REAGENT SET (K051200) - FDA 510(k) Clearance

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

K051200 · Teco Diagnostics · Toxicology device
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Aug 2005
Decision
90d
Days
Class 2
Risk

K051200 is an FDA 510(k) clearance for the HEMOGLOBIN A1C REAGENT SET. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on August 8, 2005 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.7470 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teco Diagnostics devices

Submission Details

510(k) Number K051200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date August 08, 2005
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 99
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K051200.
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp. · Feb 2006
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · Roche Diagnostics Corp. · Sep 2005
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · Beckman Coulter, Inc. · Nov 2004
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380 · Olympus America, Inc. · Nov 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003