The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

Device Description

The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.

AI/ML Overview

The provided text describes the HemoCue Hb 301 system, its intended use, and its technological characteristics. It mentions that studies were conducted to demonstrate the performance of the system and that the intended user can easily operate it and obtain expected results. However, the text does not contain specific acceptance criteria or detailed study results that prove the device meets said criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. The document claims "The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices." This is a general statement, not a quantifiable acceptance criterion (e.g., accuracy within X%, precision within Y%).
Reported Device Performance: No specific numerical performance data (e.g., accuracy, precision, correlation coefficients, sensitivity, specificity) is provided. The text only states that the system "provide clinical results comparable to other test methods."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Studies were "conducted in-house, in clinical laboratory settings and point of care centers." Country of origin is not explicitly stated, although the submitter is in Sweden and the contact is in the USA. The text does not indicate whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The ground truth is described as being established by the hemiglobincyanide (HiCN) method, which is an international reference method. This implies a method-based ground truth rather than expert consensus on individual cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified. The ground truth method (HiCN) does not suggest an adjudication process as typically seen in image or subjective interpretation studies.

5. 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

Not applicable. This device is an automated hemoglobin system; it doesn't involve human 'readers' interpreting results in the way an AI medical imaging device might. The comparison is between the automated system and other test methods, not human performance with/without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes. The HemoCue Hb 301 system is an automated device, described as an "analyzer" for quantitative determination. The performance studies would inherently be standalone, comparing the device's output to a reference method, rather than involving human interpretation or modification of results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Method-based ground truth: The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, which is explicitly stated as "the international reference method for the determination of the hemoglobin concentration in blood."

8. The sample size for the training set

Not applicable/Not specified. The device is "factory calibrated and needs no further calibration." This suggests that the calibration was done during manufacturing, likely using a set of samples, but the text does not refer to it as a "training set" in the context of machine learning, nor does it provide a sample size.

9. How the ground truth for the training set was established

Not applicable/Not specified as a "training set." The system is "calibrated against the hemiglobincyanide (HiCN) method." This method would have been used to establish the true hemoglobin values for the samples used in the factory calibration process.

In summary, while the document confirms performance studies were conducted, it lacks the specific quantitative details (acceptance criteria, numerical performance results, sample sizes, and expert qualifications) that would be needed to fulfill many of your requested points. The focus of this 510(k) summary is on establishing substantial equivalence to a predicate device (HemoCue Hemoglobin 201 system), rather than providing a detailed breakdown of validation study results with specific performance metrics against pre-defined acceptance criteria.

Summary

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K061047

JUN - 8 2006

5.0 510(k) Summary

Submitter:	HemoCue ABBox 1204Ängelholm, Sweden SE-262 23+46 431 45 82 00 (Telephone)+46 431 45 82 25 (FAX)
Contact:	Mr. Allan White (Official Correspondent)HemoCue, Inc.40 Empire DriveLake Forest, CA 92630-2244(949) 859-2630 x110 (Telephone)(949) 598-8630 (FAX)allan@hemocue.com
Date of Preparation:	April 13, 2006
Proprietary Name:	HemoCue Hb 301 system
Classification Name:	Automated and Semi-Automated Hematology Devices,Automated hemoglobin system (21 CFR § 864.5620),Product code: GKR
Common Name:	Hemoglobin analyzing system
Equivalent to:	HemoCue AB claims substantial equivalence to the current legallymarketed HemoCue Hemoglobin 201 system (K032203)

Description

Intended use

Technological Characteristics

The technological characteristics for HemoCue Hb 301 system are equivalent to the predicate devices. The system consists of an analyzer (photometer) together with microcuvettes. The microcuvette is made of polystyrene plastic and contains no active ingredients. The

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microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. A blood sample of approximately 10 uL is drawn into the cavity by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO2 isobestic point. The analyzer measures at two wavelengths (506 and 880 nm) in order to compensate for turbidity. The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, the international reference method for the determination of the hemoglobin concentration in blood. The system is factory calibrated and needs no further calibration.

Claim	Similarities
Intended use	Quantitative point-of-care hemoglobin determination in primary careusing a specially designed analyzer and specially designedmicrocuvettes. The HemoCue systems are for In Vitro Diagnosticuse only.
Result	Quantitative
Positioning	Point of Care
Analyte	Hemoglobin
Specimen	Whole blood
Labeling	Equal Directions For Use

Similarities with predicate device

Assessment of Performance

Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Hb 301 system and that the intended user can easily operate the system and obtain results as expected.

Conclusion

The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 8 2006

Mr. Allan White Official Correspondent HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630-2244

K061047 Re:

Trade/Device Name: HemoCue® Hb 301 System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: II Product Code: GKR Dated: April 13, 2006 Received: April 14, 2006

Dear Mr. White:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

loburtz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K061047

Device Name: HemoCue® Hb 301 system

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safery

J(K) K061047

HemoCue® Hb 301 system

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).