Cleared Traditional

K140827 - SD A1cCare System

K140827 is the FDA 510(k) clearance for SD A1cCare System by Sd Biosensor, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 547-day FDA review.

K140827 · Sd Biosensor, Inc. · Chemistry device
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Sep 2015
Decision
547d
Days
Class 2
Risk

K140827 is an FDA 510(k) clearance for the SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Sd Biosensor, Inc. (Suwon-Si, KR). The FDA issued a Cleared decision on September 30, 2015 after a review of 547 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 Sd Biosensor, Inc. devices

Submission Details

510(k) Number K140827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date September 30, 2015
Days to Decision 547 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
459d slower than avg
Panel avg: 88d · This submission: 547d
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 K140827.
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · Alfa Wassermann Diagnostic Technologies, LLC · Feb 2018
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
K160762 · Diazyme Laboratories · Nov 2016
URight Hemoglobin A1c system, FORA A1c System
K142664 · Taidoc Technology Corporation · Jan 2016
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