The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

For In Vitro Diagnostic Use Only

Device Description

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoqlobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the HemoPoint® H2 Hemoglobin Measurement System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Precision	Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device ≤ 2%	HemoPoint® H2 device with HemoPoint® H2 cuvettes:- Hemoglobin/high (17.3 g/dL): Swr 0.111 g/dL, CV 0.6 %- Hemoglobin/low (10.7 g/dL): Swr 0.095 g/dL, CV 0.9 %- Hemoglobin/normal (12.9 g/dL): Swr 0.084 g/dL, CV 0.7 %HemoCue device with HemoPoint® H2 cuvettes:- Hemoglobin/high (17.3 g/dL): Swr 0.103 g/dL, CV 0.6 %- Hemoglobin/low (10.7 g/dL): Swr 0.068 g/dL, CV 0.6 %- Hemoglobin/normal (12.9 g/dL): Swr 0.102 g/dL, CV 0.8 %All reported CVs are ≤ 2%
	Total Precision (NCCLS EP5-A)	HemoPoint® H2 device with HemoPoint® H2 cuvettes:- Hemoglobin/high: ST 0.207 g/dL, CV 1.2 %- Hemoglobin/low: ST 0.114 g/dL, CV 1.1 %- Hemoglobin/normal: ST 0.148 g/dL, CV 1.1 %HemoCue device with HemoPoint® H2 cuvettes:- Hemoglobin/high: ST 0.162 g/dL, CV 0.9 %- Hemoglobin/low: ST 0.086 g/dL, CV 0.8 %- Hemoglobin/normal: ST 0.134 g/dL, CV 1.0 %All reported CVs are ≤ 2% (implicitly met as they align with typical clinical acceptance for total precision given the within-run values)
	Between-Day Imprecision	HemoPoint® H2 device with HemoPoint® H2 cuvettes:- 10.7 g/dL: SD 0.102 g/dL, CV 1.0 %- 12.9 g/dL: SD 0.141 g/dL, CV 1.1 %- 17.3 g/dL: SD 0.169 g/dL, CV 1.0 %HemoCue device with HemoPoint® H2 cuvettes:- 10.9 g/dL: SD 0.094 g/dL, CV 0.9 %- 13.0 g/dL: SD 0.126 g/dL, CV 1.0 %- 17.2 g/dL: SD 0.148 g/dL, CV 0.9 %All CVs ≤ 2%
Correlation	Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.98	R=0.999 (HemoPoint® H2 System compared to NCCLS H15-A3) (Meets criteria)
	Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: ≥ 0.97	R=0.999 (HemoPoint® H2 cuvettes on HemoCue device compared to HemoCue system) (Meets criteria)

2. Sample Size Used for the Test Set and Data Provenance

HemoPoint® H2 System vs. NCCLS H15-A3 Reference Method:
- Sample Size: N=174 duplicate measurements
- Data Provenance: Venous blood samples from "4 Clinical Study Sites." The country of origin is not specified but is implied to be within the scope of the manufacturer (USA, Texas). The data appears to be prospective for the purpose of this study.
HemoPoint® H2 System vs. HemoCue System:
- Sample Size: N=286 duplicate measurements
- Data Provenance: Venous blood samples from "4 Clinical Study Sites." Country of origin not specified, implied USA. Appears to be prospective.
HemoPoint® H2 Cuvettes on HemoCue Device vs. HemoCue System:
- Sample Size: N=286 duplicate measurements
- Data Provenance: Venous blood samples from "4 Clinical Study Sites." Country of origin not specified, implied USA. Appears to be prospective.
Precision Study (Implied Test Set - different samples for different levels): The NCCLS EP5-A standard typically involves multiple replicates over several days for each sample level to determine precision components. Exact sample sizes per level are not explicitly stated as "test set" samples, but the calculation of standard deviation (Swr, ST) and CVs implies a sufficient number of measurements per level to achieve statistical significance for precision.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for this device is based on reference laboratory methods, not expert interpretation of images or clinical cases.

NCCLS H15-A3 reference method: This is a standardized laboratory method (cyanmethemoglobin method or a modified azide methemoglobin method), not an expert panel. Therefore, no "experts" in the sense of clinicians or radiologists were used to establish the ground truth. The expertise lies in performing a validated laboratory method.
HemoCue System: This is another established device used as a comparator, representing a reliable measurement itself.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by objective laboratory measurements (reference methods or established devices), not by expert opinion requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted as this is a device for quantitative hemoglobin measurement, not an AI-assisted diagnostic imaging interpretation system. The "comparison" is between the device's quantitative output and established reference methods or predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance studies for the HemoPoint® H2 system. The device directly measures and calculates hemoglobin levels. There is no human interpretation or intervention in the measurement process that further refines the algorithm's output. The human interaction is limited to operating the device and inserting the sample.

7. The Type of Ground Truth Used

The ground truth used is laboratory reference methods:

NCCLS H15-A3 reference method: This is a chemical/photometric method (cyanmethemoglobin method, or modified azide methemoglobin method) considered the gold standard for total hemoglobin determination.
HemoCue System: An established and legally marketed predicate device, recognized for its accuracy in hemoglobin measurement, also served as a ground truth comparator.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its size. As a photometric measurement device, its underlying principles are based on physicochemical laws (Lambert-Beer's law) and robust chemical reactions, rather than machine learning models that are "trained" on large datasets in the conventional sense. The device is calibrated and validated against reference methods and predicate devices for its performance.

9. How the Ground Truth for the Training Set Was Established

Since there is no explicit mention of a "training set" in the context of machine learning, the concept of establishing ground truth for a training set as described for AI algorithms is not applicable here. The device's fundamental function relies on established chemical and optical principles. Any internal calibration or factory adjustments would be against known standards, which are derived from existing reference methods like NCCLS H15-A3 or ICSH.

Summary

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OCT 2 4 2003

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K032482'. The characters are written in a clear, handwritten style, with each digit and letter easily distinguishable. The sequence appears to be a code or identifier, possibly a serial number or a reference code.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

(As required bv 21 CFR 807.92)

Trade Name:	HemoPoint® H2 Hemoglobin Measurement System
Common/Classification Name:	Automated Hemoglobin System
Device Classification:	Class: IICFR: 21 CFR 864.5620Product Code: GKR
Manufacturer:	Stanbio Laboratory1261 North Main StreetBoerne, Texas 78006

Device Description / Procedure Principle:

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes.

The recognized reference method for tHb determination (tHb = total hemoglobin) is the cvanmethemoglobin method. which is also known as the cvanhemoglobin method. The blood sample is diluted 1:251 with a reagent buffering solution. Here the erythrocytes are hemolysed and the bivalent iron in oxy- and desoxyhemodlobin are oxidised by the reagent potassium hexacvanoferrate (II) to trivalent iron and so converted to methemoglobin. Together with cyanide ions, which are also contained in the reagents, the methemoglobin forms a stable, colored complex, namely cyanmethemoglobin. This has a wide absorption maximum at 540 mm. This absorption is proportional to the tHb concentration.

In 1966. Vanzetti suggested to replace KCN by NaN, and thus was able to reduce the toxicity of the reagent mixture considerably.

Vanzetti's method is also known as the azide methemogobin method. A modified azide methemoqlobin method is used in the HemoPoint® H2 system,

In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed.

In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured.

Image /page/0/Picture/12 description: The image shows a diagram of an absorbing solution with concentration c. The diagram shows a light source on the left side, an absorbing solution in the middle, and a detector on the right side. The light source emits light with intensity P0, which passes through the absorbing solution with thickness b, and the detector measures the intensity of the light after it has passed through the solution, which is P.

Principle of photometric transmitted light measurement.

P .: 100 % - light intensity, P: remaining light intensity, b: distance through the solution

For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law.

Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D

Intended Use:

The HemoPoint H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/L or 12.0 to 18.0 g/dL). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values and will not be reported.

For In Vitro Diagnostic Use Only

Comparison To Predicate Device: Precision:

Within-run imprecision HemoPoint® H2 System and HemoPoint® H2 Cuvettes on HemoCue Device ≤ 2%

	HemoPoint® H2 cuvette measuredin HemoPoint® H2 device	HemoPoint® H2measured in HemoCuedevice
Hemoglobin/high(17.3 g/dL):Within-Run Precision(NCCLS EP5-A):	Swr 0.111 g/dL, CV 0.6 %	Swr 0.103 g/dL, CV 0.6 %
Total Precision(NCCLS EP5-A):	ST 0.207 g/dL, , CV 1.2 %	ST 0.162 g/dL, CV 0.9 %
Hemoglobin/low(10.7 g/dL)Within-Run Precision(NCCLS EP5-A):	Swr 0.095 g/dL, CV 0,9%	Swr 0.068 g/dL, CV 0,6%
Total Precision(NCCLS EP5-A):	ST 0.114 g/dL, CV 1.1%	ST 0.086 g/dL, CV 0.8%
Hemoglobin/normal(12.9 g/dL)Within-Run Precision(NCCLS EP5-A):	Swr 0.084 g/dL, CV 0.7%	Swr 0.102 g/dL, CV 0.8%
Total Precision(NCCLS EP5-A):	ST 0.148 g/dL, CV 1.1%	ST 0.134 g/dL, CV 1.0%
Between-DayImprecisionSingle observation,20 days	10.7 g/dL: SD 0.102 g/dL, CV 1.0 %12.9 g/dL: SD 0.141 g/dL, CV 1.1 %17.3 g/dL: SD 0.169 g/dL, CV 1.0 %	10.9 g/dL: SD 0.094 g/dL,CV 0.9 %13.0 g/dL: SD 0.126 g/dL,CV 1.0 %17.2 g/dL: SD 0.148 g/dL,CV 0.9 %

Correlation Study:

Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.98

Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: ≥ 0.97

$$\mathbf{2} - \mathbf{3}$$

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CONT'D

Experimental Data:

HemoPoint® H2 System: (HemoPoint® H2 cuvettes measured in HemoPoint® H2 device):

Regressionlinecorrelationand	Y= 0.023 + 1.006X
coefficients compared to NCCLS H15-A3	R=0.999
reference method (g/dL), venous blood	N=174, duplicate measurements
(Summary from 4 Clinical Study Sites)	Range 3.31 g/dL to 24.4 q/dL
Regressionlinecorrelationand	Y= - 0.233 +1.001X
coefficientscompared to HemoCue	R=0.998
system (g/dL), venous blood,	N=286, duplicate measurements
(Summary from 4 Clinical Study Sites)	Range 3.25 g/dL to 23.85 g/dL

HemoPoint® H2 cuvettes measured in HemoCue device':

Regression line and correlation coefficients compared to HemoCue system (g/dL), venous blood, (Summary from 4 Clinical Study Sites)	Y= 0.139 +986X R=0.999 N=286, duplicate measurements Range 3.25 g/dL to 23.85 g/dL
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Comparison to Predicate Device:

Specification	HemoPoint® H2	HemoCue	Comments
Instrument :	No. 1	No. 2	No.1 <-> No. 2
Measurement range	0 - 25.6 g/dL	0 - 25.6 g/dL	equivalent
Specified range	0 - 25.6 g/dL	0 - 23.5 g/dL	equivalent
Specified accuracy	$\pm$ 0.3 g/dL at ≈14 g/dL	$\pm$ 0.3 g/dL at ≈14 g/dL	equivalent
Sample material	venous, arterial or capillary human blood	venous, arterial or capillary human blood	equivalent
Measuring time	Approximately 30 - 60 sec	Approximately 30 - 60 sec	measuring time depends on the concentration
Measuring units	mol/L, g/dL, g/L	mol/L, g/dL, g/L	equivalent
Calibration	against NCCLS reference method	against ICSH reference method	NCCLS is current version of the method
Method	Azidemethemoglobin method (Vanzetti)	Azidemethemoglobin method (Vanzetti)	equivalent

Conclusion / Substantial Equivalence:

The HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes and the predicate devices, HemoCue B-Hemoglobin System with microcuvette are substantially equivalent based on design and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

OCT 2 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006

Re: K032482

Trade/Device Name: Stanbio Laboratory HemoPoint® Hemoglobin Measurement System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: August 5, 2003 Received: August 12, 2003

Dear Mr. Johnson:

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 (QS) 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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Page 2 -

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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Ko32482

510(k) Number (if known):

Stanbio Laboratory HemoPoint® Hemoglobin Measurement System Device Name:

Indications for use:

The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

For In Vitro Diagnostic Use Only

Caution: Federal law restricts this device to sale by or on the order of a physician.

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032482

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR801.109)

Over the Counter Use

(Optional Format 1-2-96)

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).