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

The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin 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.

The DM (Data Management) system allows enhanced data management features.

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 methemoglobin 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.

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).

The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the HemoPoint® H2 DM Hemoglobin Measurement System meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly listed in a separate table, but they can be inferred from the "Comparison to Predicate Device" table and the "Correlation Study" and "Precision" sections.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (HemoPoint® H2)
Precision	Within-Run Imprecision (CV)
	Hemoglobin/high (15.7 g/dL) $\leq$ 2%	CV 0.5% (HemoPoint® H2 device)
	Hemoglobin/low (11.8 g/dL) $\leq$ 2%	CV 0.6% (HemoPoint® H2 device)
	Hemoglobin/normal (8.0 g/dL) $\leq$ 2%	CV 0.7% (HemoPoint® H2 device)
	Total Precision (CV)
	Hemoglobin/high (15.7 g/dL)	CV 1.1% (HemoPoint® H2 device)
	Hemoglobin/low (11.8 g/dL)	CV 1.4% (HemoPoint® H2 device)
	Hemoglobin/normal (8.0 g/dL)	CV 1.5% (HemoPoint® H2 device)
	Between-Day Imprecision (CV)
	15.7 g/dL	CV 1.1% (HemoPoint® H2 device)
	11.8 g/dL	CV 1.5% (HemoPoint® H2 device)
	8.0 g/dL	CV 1.4% (HemoPoint® H2 device)
Correlation	Correlation coefficient vs. NCCLS H15-A3 reference method	> 0.998 -> Reported R=0.999 (HemoPoint® H2 device)
	Correlation coefficient vs. HemoCue System	> 0.995 -> Reported R=0.995 (HemoPoint® H2 device)
Accuracy	$\pm$ 0.3 g/dL at $\approx$ 14 g/dL	$\pm$ 0.3 g/dL at $\approx$ 14 g/dL (equivalent to predicate)
Measurement Range	0 - 25.6 g/dL	0 - 25.6 g/dL (equivalent to predicate)
Sample Material	venous, arterial or capillary human blood	venous, arterial or capillary human blood (equivalent to predicate)
Measuring Time	Approximately 30 - 60 sec	Approximately 30 - 60 sec (equivalent to predicate)
Measuring Units	mol/L, g/dL, g/L	mol/L, g/dL, g/L (equivalent to predicate)
Calibration	against NCCLS reference method	against NCCLS reference method (equivalent to predicate)
Method	Azidemethemoglobin method (Vanzetti)	Azidemethemoglobin method (Vanzetti) (equivalent to predicate)

Study Details

Sample size used for the test set and the data provenance:
- Precision Test Set: The number of individual samples for the precision study is not explicitly stated as a single "test set" size. However, the study for "Between-Day Imprecision" mentions "Single observation, 20 days," which implies at least 20 measurements for each hemoglobin level (high, low, normal). The "Within-Run Precision" and "Total Precision" are based on NCCLS EP5-A, which typically involves multiple replicates over several days, but the exact number of unique samples is not given.
- Correlation Study Test Set: For both correlation studies (vs. NCCLS H15-A3 and vs. HemoCue), the sample size was N=100 duplicate measurements.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective studies conducted by the manufacturer to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of "experts" in the sense of human readers adjudicating results for the ground truth.
- The ground truth for the correlation studies was established using NCCLS H15-A3 reference method and the HemoCue system (predicate device). These are established laboratory methods, not human expert consensus.
Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1) was used as the ground truth was based on laboratory reference methods (NCCLS H15-A3) or comparison to a predicate device (HemoCue), not on human expert interpretation requiring consensus.
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 MRMC comparative effectiveness study was done. This device is a quantitative hemoglobin measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the studies conducted are standalone performance evaluations of the HemoPoint® H2 system. The device itself performs the measurement and calculation of hemoglobin concentration. The "DM (Data Management) software modification" merely allows for data storage and retrieval, it does not involve an AI algorithm for diagnosis or interpretation that would typically require human-in-the-loop assessment for performance studies.
The type of ground truth used:
- Reference Method: For the accuracy and correlation studies, the ground truth was established by a recognized reference method: the NCCLS H15-A3 reference method for hemoglobin determination.
- Predicate Device Comparison: The HemoCue system (a legally marketed predicate device) was also used as a comparator/ground truth source in some correlation and precision studies.
The sample size for the training set:
- The document does not mention a "training set" in the context of an algorithm or AI model development. The HemoPoint® H2 System is a photometric device, and its core principle (Lambert-Beer's Law) and calibration are based on established chemical and optical principles, not on a machine learning model requiring a training set in the typical sense. Calibration is performed against the NCCLS reference method.
How the ground truth for the training set was established:
- Since there's no "training set" for an AI algorithm, this question is not applicable. The device is calibrated against the NCCLS reference method, which serves as the standard for establishing accuracy for the device's measurements.

Summary

{0}------------------------------------------------

K090093

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

Trade Name: HemoPoint® H2 DM Hemoglobin Measurement System Common/Classification Name: Automated Hemoglobin System Device Classification: Class: Il CFR: 21 CFR 864.5620 Product Code: GKR JUN 1 0 2009 Manufacturer: Stanbio Laboratory 1261 North Main Street Boerne, 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 cyanmethemoglobin method, which is also known as the cyanhemoglobin 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 desoxyhemoglobin are oxidised by the reagent potassium hexacyanoferrate (III) 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 nm. This absorption is proportional to the tHb concentration.

In 1966, Vanzetti suggested to replace KCN by NaN3 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 methemoglobin method is used in the HemoPoint® H2 system.

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

Image /page/0/Figure/10 description: The image shows a diagram of an absorbing solution with concentration c. The diagram shows a light source on the left side, with a light beam of intensity Pg passing through an absorbing solution of thickness b. The light beam exits the solution on the right side with a reduced intensity P. The diagram illustrates the principle of light absorption by a solution.

Principle of photometric transmitted light measurement.

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

2 - 2

{1}------------------------------------------------

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.

The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and compatible measurement systems. 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/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

The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.

Comparison To Predicate Device: (Data presented with K081719 submission) 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(15.7 g/dL):Within-Run Precision(NCCLS EP5-A):	Swr 0.087 g/dL, CV 0.5%	Swr 0.102 g/dL, CV 0.7%
Total Precision(NCCLS EP5-A):	ST 0.1747 g/dL, CV 1.1%	ST 0.302 g/dL, CV 1.9%
Hemoglobin/low(11.8 g/dL)Within-Run Precision(NCCLS EP5-A):	Swr 0.070 g/dL, CV 0.6%	Swr 0.105 g/dL, CV 0.9%
Total Precision(NCCLS EP5-A):	ST 0.162 g/dL, CV 1.4%	ST 0.198 g/dL, CV 1.6%
Hemoglobin/normal(8.0 g/dL)Within-Run Precision(NCCLS EP5-A):	Swr 0.058 g/dL, CV 0.7%	Swr 0.068 g/dL, CV 0.8%
Total Precision(NCCLS EP5-A):	ST 0.122 g/dL, CV 1.5%	ST 0.158 g/dL, CV 1.9%
Between-DayImprecisionSingle observation,20 days	15.7 g/dL: SD 0.179 g/dL, CV 1.1%11.8 g/dL: SD 0.176 g/dL, CV 1.5%8.0 g/dL: SD 0.111 g/dL, CV 1.4%	15.7 g/dL: SD 0.286 g/dL, CV 1.8%11.8 g/dL: SD 0.201 g/dL, CV 1.6%8.0 g/dL: SD 0.118 g/dL, CV 1.5%

2-3

{2}------------------------------------------------

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

Correlation Study:

Correlation coefficient HemoPoint® H2 System compared to NCCLS H15-A3 reference method, venous blood: > 0.998

Correlation coefficient HemoPoint® H2 cuvettes on HemoCue Device compared to HemoCue System, venous blood: > 0.995

Experimental Data:

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

Regression line and correlation coefficients compared to NCCLS H15-A3 reference method (g/dL), venous blood (Summary of results)	Y= 0.2929 + 1.0086XR=0.999N=100, duplicate measurements
Regression line and correlation coefficients compared to HemoCue system (g/dL), venous blood, (Summary of results)	Y= -5.8261 +1.0462XR=0.995N=100, duplicate measurements

HemoPoint® H2 cuvettes measured in HemoCue device':

Regression line and correlationcoefficients compared to HemoCuesystem (g/dL), venous blood,(Summary of results)	$Y= -0.2181 + 1.0159X$$R=0.997$$N=100, duplicate measurements$
-----------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------

Comparison to Predicate Device:

Specification	HemoPoint® H2(Predicate device)	HemoPoint® H2 (Newsubmission)	Comments
Instrument	No. 1	No. 2	No.1 $\leftrightarrow$ No. 2
Measurement range	0 - 25.6 g/dL	0 - 25.6 g/dL	equivalent
Specified range	0 - 25.6 g/dL	0 - 25.6 g/dL	equivalent
Specified accuracy	$\pm$ 0.3 g/dL at $\approx$ 14 g/dL	$\pm$ 0.3 g/dL at $\approx$ 14 g/dL	equivalent
Sample material	venous, arterial orcapillary human blood	venous, arterial orcapillary human blood	equivalent
Measuring time	Approximately30 - 60 sec	Approximately30 - 60 sec	equivalent
Measuring units	mol/L, g/dL, g/L	mol/L, g/dL, g/L	equivalent
Calibration	against NCCLS referencemethod	against NCCLS referencemethod	equivalent
Method	Azidemethemoglobinmethod (Vanzetti)	Azidemethemoglobinmethod (Vanzetti)	equivalent

{3}------------------------------------------------

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

Conclusion / Substantial Equivalence:

The modified software for the HemoPoint® H2 Hemoglobin Photometer and and the predicate devices, Hemo Point® H2 Hemoglobin Measurement System with microcuvette are substantially equivalent based on design and function.

Kirk Johnson QA/Regulatory Affairs Manager Stanbio Laboratory

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Stanbio Laboratory c/o Mr. Kirk Johnson OA/Regulatory Affairs Manager 1261 North Main Street Boerne, TX 78006

JUN 1 0 2009

Re: K090093

Trade/Device Name: HemoPoint® H2 DM Hemoglobin Measurement System Regulation Number: 21 CFR §864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: Class II Product Code: GKR Dated: May 27, 2009 Received: May 28, 2009

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 vour device as described in your Section 5:10(k) premarket notification. The FDA finding of

{5}------------------------------------------------

Page 2 - Mr. Kirk Johnson

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K090093

Device Name: Stanbio Laboratory HemoPoint® H2 DM Hemoglobin Measurement System

Indications For Use:

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

The DM (Data Management) system allows enhanced data management features.

For In Vitro Diagnostic Use Only

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

Prescription Use (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)

Nemul Jr.
Division Sign-Off

Division Sign-Off

510kl

Office of In Vitro Diagnostic
Device Evaluation and Safety
1/1 - - - - - - - - - - - - - - - - - - - - - -

Kog nog a

Page 1 of __

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).