HemoCue Hb 201 Data Management System

Product Description

The HemoCue Hb 201 DM system is a data management solution for hemoglobin testing and anemia screening. It is a way to manage patient information as it has QC lockout and barcode scanning for patient ID. The HemoCue system can be linked with existing systems using POCT-1A (Point of Care Testing standards).

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$2,120.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Some Larger Distributors include: Radiometer Medical, HCE (Health Care Equipment) and CliaWaived.com Distributors vary by country, more information can be found on HemoCue's website: Europe, Asia/Pacific, Middle East.

Manufacturing/Building Method

The product is mass-produced by HemoCue, headquartered in Sweden.

Intellectural Property Type

Patent

User Provision Model

HemoCue has a number of distributors in their target countries in Asia, Europe, Middle East, and the Americas. Users can purchase the DM system from these distributors.

Distributions to Date Status

The distribution to date is unknown.

Consumables

HemoCue Hb 201 microcuvettes

Blood test materials (lancet, disinfectant, gloves)

Detection sensitivity

0 – 25.6 g/dL (0 – 256 g/L, 0 – 15.9 mmol/L)

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

Yes

Number of Tests Performed

One

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Rechargeable battery and AC adapter

Time required for procedure (minutes)

1 min

Design Specifications

A blood sample is collected in a HemoCue microcuvette which is placed in the device. The user then follows the steps on the screen to run the test. The specification of the operation can be found in this manual.

Product Schematics

Technical Support

There is a user manual for the system. Additional technical support is provided by HemoCue distributors and their technicians based on location.

Replacement Components

To purchase replacement components the user should contact their local distributor.

Lifecycle

Unknown

Manufacturer Specified Performance Parameters

Factory calibrated against the ICSH reference method
Results within 60 seconds
Results Storage: 4,000 patient/STAT tests, 500 QC tests, 500 analyzer logs, 200 patient IDs
Reduced transcription errors
Wireless connection capabilities
Lab quality accuracy

Vetted Performance Status

This product correctly classified patients’ anemic status in 80% or more of instances. The HemoCue® gravity method was found to be more accurate than the HemoCue® wicking method.

Safety

There is a risk of inaccurate results if the storage instructions are not followed.

Complementary Technical Systems

The HemoCue Hb system can be connected with existing systems as it complies with the Point of Care Connectivity standard. The system has bidirectional communication with middleware applications such as RALS, AegisPOC, & Telcor.

Academic Research and References

Sanchis-Gomar, F., Cortell-Ballester, J., Pareja-Galeano, H., Banfi, G. and Lippi, G., 2012, Hemoglobin Point-of-Care Testing, Journal of Laboratory Automation, 18(3), pp. 198–205.

Parker, M., Han, Z., Abu-Haydar, E., Matsiko, E., Iyakaremye, D., Tuyisenge, L., Margaret, A. and Lyambabaje, A., 2018, An Evaluation of Hemoglobin Measurement Tools and their Accuracy and Reliability when Screening for Child Anemia in Rwanda: A Randomized Study, Plos One, 3(1).

Gwetu, T.P. and Chhagan, M.K., 2015, Evaluation of the Diagnostic Accuracy of the HemoCue Device for Detecting Anaemia in Healthy School- Aged Children in KwaZulu-Natal, South Africa, South African Medical Journal, 105(7), p. 596.

Levy, T.S., Méndez-Gómez-Humarán, I., Ruán, M.D.C.M., Tapia, B.M., Hernández, S.V. and Ávila, M.H., 2017, Validation of Masimo Pronto 7 and HemoCue 201 for Hemoglobin Determination in Children From 1 to 5 years of Age, Plos One, 12(2).

Marwick, P.C., Johnson, M., Coetzee, J.F., Levin, A.I., 2016, Abstract PR612: Hemocue® Haemoglobin Concentration Measurements are More Accurate than those of Blood Gas Analysers and Assist in Avoiding Incorrect Transfusion Decisions, Anesthesia & Analgesia, 123, pp. 779–780.

HemoCue, “Operation Manual”

HemoCue, “Instructions”

HemoCue, “Indications of Use“, DEPARTMENT OF HEALTH & HUMAN SERVICES, 2004.

“Class 2 Device Recall HEMOCUE Hb 201 DM ANALYZER“, U.S. Food and Drug Administration

Compliance with regulations

The HemoCue 201 Hb DM system is FDA approved. It complies with the 7-71 CLSI H15-A3 (Replaces H15-A2) standard for Quantitative Determination of Hemoglobin in Blood. The HemoCue 201 Hb DM system and the HemoCue 201 Microcuvettes has a CE - Mark. The HemoCueHb 201 Microcuvettes comply with the IVD Medical Device Direc-tive 98/79/EC and carry the CE mark. This, therefore, means that the product is approved for use in the European community.

Evaluation methods

A premarket evaluation was done by the Center for Biologics Evaluation & Research (CBER). Evaluation methods involved comparing the results of HemoCue blood tests to laboratory results for the same patients. In another research by Back et al. - Between 119 and 138 samples were analyzed at 4 different hospitals - Correlation for all systems against the reference method was better than 0.99 - Correlations between the new Hb 201+ and ADVIA 120 (Bayer Diagnostics), GEN-S (Beckman Coulter), Sysmex XE 2100, CellDyn 4000 (Abbott), and the HemoCue B-Hemoglobin system showed all r > 0.99. - The Hb 201+ system yields results that agreed well with comparative systems. - The system achieved accuracy and precision similar to the available cell counters.

Other Information

In 2011 the system was recalled for 3 months due to a programming error.

Comments from the Community

2 Comments

E4C.COMMENTS says:

October 28, 2016 at 5:11 am

Jeremy Schonhorn says:

Hemocue IP

Lindberg, Stellan, and Johnny Svensson. 2009. Enumeration of white blood cells. USPTO 7521243. US Patent, filed April 11, 2005, and issued April 21, 2009. https://www.google.com/pate….
Stephen_Advisor says:

September 5, 2018 at 2:52 pm

Sweden is spelled incorrectly in the “Manufacturing/building method(s)” section. The first sentence in the “User Provision Model” section is not clear and should be rewritten.

Regarding the “Distribution to date”, even if exact numbers are not known, a rough order of magnitude estimation would add significant value.