Cleared Traditional

K010748 - SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT

K010748 is an FDA 510(k) clearance for SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K010748 · Beckman Coulter, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
119d
Days
Class 2
Risk

K010748 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT. 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 July 10, 2001 after a review of 119 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K010748

510(k) Number K010748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date July 10, 2001
Days to Decision 119 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 113d · This submission: 119d
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 Hematology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K010748.
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc. · Nov 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · Tosoh Medics, Inc. · Sep 2001
VARIANT II TOTAL GHB
K003280 · Bio-Rad · Dec 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · Roche Diagnostics Corp. · Dec 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · Abbott Laboratories · May 2000