Cleared Special

K090413 - A1CNOW+ (10 TEST KIT

K090413 is an FDA 510(k) clearance for A1CNOW+ (10 TEST KIT, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 85-day FDA review.

K090413 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
85d
Days
Class 2
Risk

K090413 is an FDA 510(k) clearance for the A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROF.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Sunnyvale, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K090413

510(k) Number K090413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2009
Decision Date May 14, 2009
Days to Decision 85 days
Submission Type Special
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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00798486 Completed Interventional Industry-sponsored

Evaluation of the A1CNow+ Test Kit

In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals

110
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Anna Chang, MD
Sponsor Ascensia Diabetes Care (industry)
Started 2008-11-01 → Primary completion 2008-12-01
Primary outcome
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
Secondary outcome
Average Within Subject Coefficient of Variation CV (PRECISION)
View full study on ClinicalTrials.gov

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 166
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K090413.
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
K082275 · Infopia Co, Ltd. · Jan 2010
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Dec 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc. · Jul 2009
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · Horiba Abx · Oct 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · Tosoh Bioscience, Inc. · Sep 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · Jas Diagnostics, Inc. · May 2008