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18 / CAP TODAY February 2010

Bedside glucose testing systems

Arkray Inc. HemoCue Inc.

5198 W. 76th St. 40 Empire Dr.

Edina, MN 55439 Lake Forest, CA 92630-2244

800-818-8877 800-323-1034

Part 3 of 7

www.arkrayusa.com www.hemocue.com

Name of instrument/First year sold

Assure 4/2007 Glucose 201 DM Analyzer/2005

Professional or home use

professional use professional use

List price

free with competitive trade out —

Units sold in U.S./Outside U.S./In 2009

— —

Part of series of similar or related models

yes yes

Dimensions (H x W x D)/Weight

3.9 × 2.3 × 1.0 in/2.5 oz without batteries 6.7 × 3.7 × 2 in/0.77 lb

Analytical method/Technology/Enzyme system used

glucose oxidase absorbance photometry/glucose dehydrogenase

Price per disposable reagent system unit

contact sales representative —

No. of dispos. reag. system units per basic package

50 or 100 25 in vial/box; 4 vials/boxes per package

No. of times analyses performed using 1 reag. system unit

1 1

Dispos. units shelf life/Reag. unit storage requirements

18 months/room temperature 9 months from manufacture date/refrigeration

Digital readout size/Keypad input capability

—/none varies from 8 to 28 points/menu selection, numeric, alphabetic

How results are displayed

true values calculated values (plasma equivalent values [11%] measured whole

blood value x 1.11)

Specimen types/Sampling techniques

whole blood/capillary transfer whole blood (capillary, venous, arterial)/exact amount of blood drawn

into cuvette by capillary force

Minimum specimen volume required

1.5 µL 5 µL

Suitable for samples from well/Sick neonates

no/no yes/no (may require laboratory conﬁrmation)

Time from sample intro. to result availability

10 seconds 40–240 seconds

Batteries used/No. used/Avg. life of one set

1.5 V alkaline AAA/2/3,000 tests rechargeable lithium ion supplied by HemoCue/—/several years

Avg. expected life of device/Mean time between failures

— 7 years/>5 years

Device warranty/Service options

5 years/— 2 years, at no additional cost/replacement of defective analyzer

Loaners provided

yes yes

User list or user group

no no

Toll-free No. for customer questions/Hours

800-818-8877/24 hours, 7 days 800-323-1674, 6 a m –5 p m PST

Training and certif. program/No. training days provided

yes/as needed yes/~1 hour per device purchased

Avg. time for lab to complete maintenance

weekly: 5 minutes daily: ≤5 minutes

Special cleansing procedures

no no

Internal QC recommended or required

as speciﬁed by accreditation one level of controls prior to patient testing, each day of testing

Between instrument CV (based on PT) at these levels:

• <50 mg/dL

— not available

• 100–200 mg/dL

— 3.8

• >400 mg/dL

— ≥272 mg/dL=2.9

• Program name, year/Challenge No./Level of mean glucose challenge sample

— Equalis (Swedish PT program), 2003/2003–03; 2003–07/272 mg/dL;

120 mg/dL

Accuracy/Compared to what reference method or device

slope=1.010/r=0.993/ YSI glucose analyzer ±10% or ±6% mg/dL; corr=0.994/wet chemical glucose dehydrogenase,

ID-GCMS

Precision/Compared to what reference method or device

4.1%/— within run CV 1.9% (108 mg/dL)/—

Linear range

30–550 mg/dL 0–444 mg/dL

Suggested dynamic, measurement range

30–550 mg/dL 0–444 mg/dL

Contraindications

no no

Known interferences/High-altitude interference

per labeling/no (tested up to 7,000 feet) grossly lipemic samples, methemoglobin, glucosamine/no

Restrictions based on hematocrit

yes, 30%–55% no

Electronic, optical function checks

sumcheck functions for electronics and software, no optics internal electronic self-test automatically checks that the instrument’s

optronic unit is working properly

Sample quantity checks

— visual inspection

When auto lock or shutdown occurs

— user ID failure if conﬁgured to require operator ID; QC failure if conﬁgured

to require quality control; number of device errors

User deﬁnes QC lockout intervals/Lockout can be circumvented

no/— yes/no (stat testing may be allowed; 1–100 tests after QC interval)

Device supports bar-code scanning of

no bar-code scanner operator & patient identiﬁers, reagent lot Nos., comments, log entries,

lab ID

Method of analyst ID/ID required

— alphanumeric manual entry or bar-code scan entry/optional

Internal memory size/Max. No. patient results stored

50-test memory/50 4,000 patient tests/500 QC tests, 500 analyzer log entries/4,000

Information transfer capability:

• Meters connect to

— analyzer connects to 201 DM docking stations (data management

system, which can further transmit data)

• How meters are connected to external system to upload results/

No. installations

— direct USB/hospital network

• Info. contained in transmission to external system

— device unique identiﬁers, operator & patient IDs, results, QC identiﬁers,

POCT-1A standard compliant, date/time, lab ID, ﬂags

Hardware/software for data mgmt. system

— PC/server/HemoCue 201 DM–DMS software

No. of different mgmt. reports system can produce

— 15 different templates, custom reports based on templates, multiple

export formats

Contents downloaded from DMS to meter

— cuvette lot No., valid control values, valid operator IDs, comments,

analyzer log entries, analyzer conﬁguration

System connected (live installations) to which LISs/HISs:

—

• using screen animation/screen scraping

— —

• using standard HL7 interface

— —

• using proprietary protocol interface

— —

Use 3rd-party interfacing tool/engine for LIS/HIS interfaces

— Telcor QML/Quick-Linc, Radiometer Radiance, Conworks POCcelerator

Distinguishing features (provided by vendors)

small sample size: 1.5 µL; fast test time: 10 seconds; large strip handle POCT-1A compliant; indicated for diagnosis of diabetes mellitus; not

hematocrit-dependent

Tabulation does not represent an endorsement by the College of American Pathologists.

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