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.

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.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study for the HemoCue® Hb 301 System, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated as "comparable performance")	Reported Device Performance (HemoCue® Hb 301 System)
Accuracy compared to reference method ICSH for pediatric samples: Regression analysis demonstrating comparable performance.	Pediatric Samples (vs. ICSH): Slope: 0.98 Correlation coefficient (r): 0.99
Accuracy compared to predicate device (HemoCue® Hb 801 System): Regression analysis demonstrating comparable performance.	Vs. HemoCue® Hb 801 System: Slope: 0.97 Correlation coefficient (r): 0.99

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 71 pediatric blood samples.
- Data Provenance: Tested at one European clinical laboratory site. The data appears to be prospective as it describes a specific evaluation done to compare the device to the reference method and predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth.
Adjudication method for the test set:
- The document does not specify an adjudication method. The ground truth was established by a reference method (ICSH), which inherently has its own established protocol for measurement, rather than relying on expert consensus adjudication in this context.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is not applicable. The HemoCue® Hb 301 System is an automated hemoglobin analysis device, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study described is a direct comparison of the device's measurements (algorithmically determined hemoglobin concentration from photometric readings) against a reference method and a predicate device. The HemoCue® Hb 301 System itself performs the analysis without human interpretation of the final result. While "human-in-the-loop" isn't strictly defined for this type of device, the performance presented is of the automated system.
The type of ground truth used:
- The primary ground truth used was the hemiglobincyanide (HiCN) method (ICSH reference method) for the determination of hemoglobin concentration.
The sample size for the training set:
- The document does not explicitly state a sample size for a "training set" in the context of machine learning, as this device uses spectrophotometric measurements and an algorithm for translation into hemoglobin concentration, rather than a deep learning model that requires a distinct, large training set. The system is described as "factory calibrated."
How the ground truth for the training set was established:
- The document states that "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." This implies that the factory calibration (which is analogous to what might be considered a "training" or calibration phase for the device's internal algorithm) was established using the ICSH reference method as the gold standard. Specific details on the establishment of this ground truth for the factory calibration are not provided in this specific excerpt, beyond stating its traceability.

Summary

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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

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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

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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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Enclosure 2

510(k) Summary

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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 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 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 Analyzer14.5	Image: HemoCue Hb 801 System Analyzer14.2
Microcuvette	Image: HemoCue Hb 301 System MicrocuvetteM	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 isintended for quantitativedetermination of hemoglobin inprimary care or blood donationsettings. The HemoCue® Hb 301System is intended to be used todetermine the hemoglobinconcentration for adults, adolescents,children, and infants above 1 monthold in primary care setting.The HemoCue® Hb 301 System isintended to be used to determine thehemoglobin concentration for adultsin blood donation setting.The HemoCue® Hb 301 System is forprofessional in vitro diagnostic useonly.	The HemoCue® Hb 801 System isintended for the quantitativeDetermination of hemoglobin incapillary or venous wholeblood (K2EDTA and Li-Heparin) inpoint-of-care settings. The HemoCue®Hb 801 System is intended to be used todetermine the hemoglobinconcentration for adults, adolescents,children, and infants above 1 monthold. The HemoCue® Hb 801 System isfor professional in vitro diagnostic useonly.
Patient population	Adults, adolescents, children, andinfants 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 thehemiglobincyanide (HiCN) method,according to ICSH. The system isfactory calibrated and needs nofurther calibration.	Same
Quality control	Internal self-test (verifying analyzerperformance)	Same
Differences
Sample type	Capillary, venous or arterial wholeblood	Capillary or venous whole blood
Measuring range	0-25.6 g/dL	1-25.6g/dL
Connectivity	Serial port	• Wireless Bluetooth LowEnergy (BLE)• USB
Microcuvette insertiontechnique	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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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.

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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 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.

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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.

Regulation Number and Section

§ 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).