Agriculture
November 9, 2023
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).
Market Suggested Retail Price
$2,000.00
Target Users (Target Impact Group)
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 Protected
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.
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.
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.
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.
Other Information
In 2011 the system was recalled for 3 months due to a programming error.
Explore similar solutions
Agriculture
November 9, 2023
Clean Team Toilet Waste Management Service
Read Solution
Agriculture
November 9, 2023
Myanmar Information Management Unit (MIMU)
Read Solution
Agriculture
November 9, 2023
Sanergy Fresh Life Waste Management Service
Read Solution
Agriculture
November 9, 2023
X-Runner Waste Management Service
Read Solution
Agriculture
November 9, 2023
Vaccine Management Solution using e-voucher
Read Solution
Agriculture
November 9, 2023
SORMAS (Surveillance Outbreak Response Management & Analysis System)
Read Solution
Agriculture
November 9, 2023
Open Data Kit
Read Solution
Agriculture
November 9, 2023
Premise Data
Read Solution
Agriculture
November 9, 2023
Humanitarian Data Exchange
Read SolutionGet more information about Solutions Library and its features.
Learn MoreHave thoughts on how we can improve?
Give Us Feedback
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….
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.