(90 days)
Not Found
No
The device uses a photometric method and a simple algorithm to translate light measurements into hemoglobin concentration. There is no mention of AI/ML techniques, training data, or complex pattern recognition.
No.
This device is an in vitro diagnostic device used for quantitative determination of hemoglobin, not for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The HemoCue® Hb 301 System is for professional in vitro diagnostic use only."
No
The device description explicitly lists hardware components such as an analyzer, power supply, and single-use microcuvettes, indicating it is a hardware-based system with embedded software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The HemoCue® Hb 301 System is for professional in vitro diagnostic use only."
- Nature of the Test: The device performs a quantitative determination of hemoglobin in blood samples. This is a laboratory test performed on biological specimens outside of the body, which is the definition of an in vitro diagnostic test.
- Device Description: The description details the use of single-use microcuvettes to collect a blood sample and an analyzer to measure the absorbance of the blood, which are typical components of an in vitro diagnostic system.
- Intended Use/Setting: The intended use in primary care and blood donation settings, performed by professionals, aligns with the typical use of IVD devices for diagnostic or screening purposes.
N/A
Intended Use / Indications for Use
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.
The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.
Product codes
GKR
Device Description
The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.
The HemoCue® Hb 301 System consists of the following parts:
- An analyzer supporting the following features: Photometric determination of hemoglobin, Presentation of results on a display
- Power supply by power adapter or four AA batteries
- Single use microcuvettes (test consumable)
- Labeling: Operating Manual, Package Insert, Quick reference Guide, Labels
The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action.
The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.
The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, adolescents, children, and infants above 1 month old
Intended User / Care Setting
Professional in vitro diagnostic use only, in primary care or blood donation settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison:
- Study Type: Measurement performance evaluation compared to the reference method ICSH with pediatric samples (infants above 1 month old, children and adolescents) according to CLSI EP09c 3rd Edition.
- Sample Size: 71 pediatric blood samples.
- Data Source: One European clinical laboratory site over 7 operating days.
- Annotation Protocol: Each blood sample was analyzed with 2 replicates on the HemoCue® Hb 301 System and with 3 replicates with the reference method ICSH.
- Key Results: Regression analysis demonstrated comparable performance. Linear regression analysis of the relationship between HemoCue® Hb 301 System and reference method ICSH resulted in a slope of 0.98 and a correlation coefficient (r) of 0.99. The study fulfills the acceptance criteria for accuracy and validates the use of the HemoCue® Hb 301 System for samples from children above 1 month old.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Correlation coefficient (r): 0.99 (between HemoCue® Hb 301 System and ICSH reference method)
- Slope: 0.98 (between HemoCue® Hb 301 System and ICSH reference method)
- Correlation coefficient (r): 0.99 (between HemoCue® Hb 801 System and HemoCue® Hb 301 System)
- Slope: 0.97 (between HemoCue® Hb 801 System and HemoCue® Hb 301 System)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 4, 2020
HemoCue AB Maria Fagerberg Senior Director RA/OA Kuvettgatan 1 Angelholm, Sweden 26271
Re: K201217
Trade/Device Name: HemoCue Hb 301 System Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR Dated: April 30, 2020 Received: May 6, 2020
Dear Maria Fagerberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201217
Device Name HemoCue® Hb 301 System
Indications for Use (Describe)
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.
The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Enclosure 2
510(k) Summary
4
1. Submitter and contact information
Submitter:
| Company Name: | HemoCue AB |
|---|---|
| ER Number: | 3003044483 |
| Address: | Kuvettgatan 1 |
| SE-262 71 | |
| Sweden |
Official contact person:
| Name: | Maria Fagerberg |
|---|---|
| Function: | Senior Director RA/QA |
| E-mail: | maria.fagerberg@hemocue.se |
| Phone: | +46 431 48 13 46 |
| Mobile: | +46 734 14 03 46 |
| Fax: | +46 431 48 12 25 |
Secondary contact:
| Name: | Andrijana Kankaras |
|---|---|
| Function: | Regulatory Affairs Specialist |
| Phone: | +46 431 48 12 26 |
| Fax: | +46 431 48 12 25 |
| E-mail: | andrijana.kankaras@hemocue.se |
Date of preparation:
April 30, 2020 Date:
2. Device information
| Proprietary name: HemoCue® Hb 301 System | |
|---|---|
| Common name: Hemoglobin analyzing system | |
| 510(k) number: | K061047 |
| Regulation: | Automated hemoglobin system (21 CFR § 864.5620) |
| Product code: | GKR |
| Classification: | Class II |
| Common name: | Hemoglobin analyzing system |
| Panel: | Hematology |
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3. Device description
The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.
The HemoCue® Hb 301 System consists of the following parts:
- An analyzer supporting the following features: .
- o Photometric determination of hemoglobin
- Presentation of results on a display o
- Power supply by power adapter or four AA batteries
- Single use microcuvettes (test consumable) ●
- Labeling: .
- O Operating Manual
- Package Insert о
- o Quick reference Guide
- o Labels
The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action.
The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.
The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.
4. Intended Use and Indications for Use
Intended Use
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.
The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.
Indications for Use Same as intended use.
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5. Substantial Equivalence
| Candidate device | Predicate device | |
|---|---|---|
| Proprietary name: | HemoCue® Hb 301 System | HemoCue® Hb 801 System |
| Common name: | Hemoglobin analyzing system | Hemoglobin analyzing system |
| 510(k) number | K061047 | K181751 |
| Product code | GKR | GKR |
| Classification | Class II | Class II |
| Regulation | 21 CFR 864.5620 | 21 CFR 864.5620 |
| Automated hemoglobin system | Automated hemoglobin system | |
| Classification Panel | Hematology | Hematology |
The most important similarities and differences between the HemoCue® Hb 301 System (Candidate Device) and HemoCue® Hb 801 System (Predicate Device) are listed in the table below.
| Characteristic | HemoCue® Hb 301 System
(Candidate device) | HemoCue® Hb 801 System
(Predicate device) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer | Image: HemoCue Hb 301 System Analyzer
14.5 | Image: HemoCue Hb 801 System Analyzer
14.2 |
| Microcuvette | Image: HemoCue Hb 301 System Microcuvette
M | Image: HemoCue Hb 801 System Microcuvette |
| Characteristic | HemoCue® Hb 301 System
(Candidate device) | HemoCue® Hb 801 System
(Predicate device) |
| | | Similarities |
| | | |
| Intended Use | The HemoCue® Hb 301 System is
intended for quantitative
determination of hemoglobin in
primary care or blood donation
settings. The HemoCue® Hb 301
System is intended to be used to
determine the hemoglobin
concentration for adults, adolescents,
children, and infants above 1 month
old in primary care setting.
The HemoCue® Hb 301 System is
intended to be used to determine the
hemoglobin concentration for adults
in blood donation setting.
The HemoCue® Hb 301 System is for
professional in vitro diagnostic use
only. | The HemoCue® Hb 801 System is
intended for the quantitative
Determination of hemoglobin in
capillary or venous whole
blood (K2EDTA and Li-Heparin) in
point-of-care settings. The HemoCue®
Hb 801 System is intended to be used to
determine the hemoglobin
concentration for adults, adolescents,
children, and infants above 1 month
old. The HemoCue® Hb 801 System is
for professional in vitro diagnostic use
only. |
| Patient population | Adults, adolescents, children, and
infants above 1 month old | Same |
| Analyte | Hemoglobin | Same |
| Sample preparation
(pre-treatment) | None | Same |
| Sample volume | 10 µL | Same |
| Measuring principle | Spectrophotometric | Same |
| Reagent | No active ingredients | Same |
| Calibration | The system is traceable to the
hemiglobincyanide (HiCN) method,
according to ICSH. The system is
factory calibrated and needs no
further calibration. | Same |
| Quality control | Internal self-test (verifying analyzer
performance) | Same |
| Differences | | |
| Sample type | Capillary, venous or arterial whole
blood | Capillary or venous whole blood |
| Measuring range | 0-25.6 g/dL | 1-25.6g/dL |
| Connectivity | Serial port | • Wireless Bluetooth Low
Energy (BLE)
• USB |
| Microcuvette insertion
technique | Tray | "Slot in" |
| Characteristic | HemoCue® Hb 301 System
(Candidate device) | HemoCue® Hb 801 System
(Predicate device) |
| | Image: HemoCue® Hb 301 System | Image: HemoCue® Hb 801 System |
| User interface | Display Beeper One button | Display Beeper Two buttons |
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8
6. Measuring principle
Spectrophotometric
7. Performance Characteristics (if/when applicable)
Analytical performance
Please refer to the initial submission K061047.
Method comparison
In addition to the method comparison studies submitted in K061047, the measurement performance of the HemoCue® Hb 301 System has been evaluated compared to the reference method ICSH with pediatric samples (infants above 1 month old, children and adolescents) according to CLSI EP09c 3rd Edition.
71 pediatric blood samples were tested at one European clinical laboratory site over 7 operating days. Each blood sample was analyzed with 2 replicates on the HemoCue® Hb 301 System and with 3 replicates with the reference method ICSH.
Regression analysis demonstrated comparable performance between the HemoCue® Hb 301 System and ICSH.
In the linear regression analysis of the relationship between HemoCue® Hb 301 System and reference method ICSH, have a slope 0.98 and a correlation coefficient (r) 0.99.
In the linear regression analysis of the relationship between the predicate device HemoCue® Hb 801 System and the HemoCue® Hb 301 System, have a slope 0.97 and a correlation coefficient (r) 0.99, please refer to K181751.
9
The measurement performance evaluation of the HemoCue® Hb 301 System in comparison to ICSH method fulfills the acceptance criteria for accuracy, and validates the use of the HemoCue® Hb 301 System for samples from children above 1 month old.
Clinical studies
- a. Clinical Sensitivity N/A
- b. Clinical specificity N/A
- Other clinical supportive data (when a. and b. are not applicable): C. N/A
Clinical cut-off
N/A
8. Instrument name
HemoCue® Hb 301 System
9. System Description
- a. Mode of operation
The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer.
The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action.
The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.
The HemoCue® Hb 301 System is be traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.
- b. Software
Please refer to the initial submission K061047.
10
-
c. Specimen Identification
There is no specimen identification function for the HemoCue® Hb 301 System. -
d. Specimen Sampling and Handling
A whole blood sample of approximately 10 uL is drawn into the cavity in the HemoCue® Hb 301 Microcuvette by capillary action. To perform a hemoglobin reading, a filled microcuvette is inserted into the microcuvette holder in the HemoCue® Hb 301 Analyzer. -
e. Calibration
The HemoCue® Hb 301 System is factory calibrated and needs no further calibration. -
f. Quality Controls
The HemoCue® Hb 301 Analyzer has an internal quality control, a self-test. Every time the analyzer is turned on, it will automatically verify the system performance. This test is performed at regular intervals if the analyser remains switched on.
If an external quality control is required by local or other regulations, commercially available controls recommended by HemoCue should be used.
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21CFR Part 809.10.
11. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.