The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control 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/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 Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.

The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light.

The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.

The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).

AI/ML Overview

The provided documentation describes the acceptance criteria and a study demonstrating that the modified Hemo_Control Microcuvettes meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study primarily focuses on precision and correlation with a reference method. The acceptance criteria can be inferred from the reported precision (low CV%) and strong correlation (high R^2).

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implied)	Reported Device Performance (Hemo_Control modified microcuvette)
Precision	Within-Run CV%	Low CV% (e.g., < 2%)	0.7 % (8.0 g/dL), 0.6 % (11.8 g/dL), 0.5 % (15.7 g/dL)
	Total CV%	Low CV% (e.g., < 2%)	1.5 % (8.0 g/dL), 1.4 % (11.8 g/dL), 1.1 % (15.7 g/dL)
	Between-Day CV%	Low CV% (e.g., < 2%)	1.4 % (8.0 g/dL), 1.5 % (11.8 g/dL), 1.1 % (15.7 g/dL)
Accuracy/Correlation	R^2	High (e.g., > 0.95)	0.9955 (compared to CLSI H15-A3 reference method)
Linearity/Bias	Regression slope	Close to 1.0 (e.g., 0.95-1.05)	1.0086
	Regression intercept	Close to 0.0	0.2929

Note: The acceptance criteria are "implied" as specific numeric thresholds are not explicitly stated as "acceptance criteria" but rather as "results obtained" that demonstrate substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: 100 samples
Data Provenance: The document does not explicitly state the country of origin. The test used venous blood samples. It is a retrospective analysis in the sense that the samples were already collected and then tested. The study design appears to be a laboratory evaluation (non-clinical test).

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

This study is a non-clinical laboratory test comparing a device's performance to a reference method, not an interpretative study requiring human expert ground truth.

Number of Experts: Not applicable, as the ground truth was established by a reference method.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison to a reference method, not an interpretative study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a non-clinical laboratory evaluation of a modified medical device against a reference standard, not an AI-assisted diagnostic tool involving human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The precision and correlation data presented represent the performance of the modified microcuvette with the Hemo_Control device, without human interpretation as part of the measurement process. It's a "device only" performance evaluation.

7. Type of Ground Truth Used

The ground truth was established by a reference method, specifically the CLSI H15-A3 standard for the quantitative determination of hemoglobin in blood.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system, and the study described is a validation study for a device modification, not a machine learning model that requires a training set. The "device" already has its algorithm embedded.

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

Not applicable, as no training set for a machine learning model was used.

Summary

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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

(1)	Submitted by:	EKF-diagnostic GmbHEbendorfer Chaussee 3Barleben / MagdeburgD-19061 GermanyTel.: +49-(0)39203-785-0Fax: +49-(0)39203-785-16
	Contact Person:	Mr. Ronny Friedrichronny.friedrich@EKF-diagnostic.de
	Position/Title:	Quality Manager
	Date of Preparation:	January 31, 2011
(2)	Trade Name:	Hemo_Control HemoglobinMeasurement System: Modification toHemo_Control Microcuvettes
		Common/Classification Name: AUTOMATED HEMOGLOBIN SYSTEM
	Product Code(s):	GKR, 21 CFR §864.5620KHG, 21 CFR §864.7500
	Class:	Class II
(3)	Predicate Device(s):	Hemo_Control HemoglobinMeasurement System (K031898)Modification To Stanbio LaboratoryHemopoint H2 HemoglobinMeasurement System (K081719)
	Reason for Submission:	Device Modification

(4) Description of Device:

・・

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Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light. 1

The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).

(5) Intended use:

The intended use, the quantitative determination of hemoglobin in blood, is unchanged by the cuvette modification.

Indications for Use:

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

For In Vitro Diagnostic Use Only

(6) Technological Characteristics:

The scope of the change in this 510(k) is limited to the microcuvette geometric dimensions. The geometry of the microcuvette is modified for easier filling of the microcuvette and to minimize possible air bubbles forming by implementing a symmetrical sample inlet.

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No changes to the Hemo_Control Hemoglobin Measurement System instrument hardware or software are considered in this special 510(k) - no changes to the instrument are required to utilize the modified cuvette.

Non-Clinical Tests Submitted: (b) (1)

Changes were evaluated in accordance with the sponsor's Design Control and Risk Management processes. Laboratory testing of the modified cuvettes was performed on venous blood samples per CLSI H15-A3. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood. A precision evaluation was peformed on 100 samples. The following results were obtained with respect to the reference method:

	HEMO_CONTROL modified microcuvettemeasured in HEMO_CONTROL device
Hemoglobin/low (8.0 g/dL)Within-Run precision (CLSIEP5-A):	SWR 0.058 g/dL, CV 0.7 %
Total precision (CLSI EP5-A):	ST 0.122 g/dL, CV 1.5 %
Hemoglobin/normal (11.8g/dL)Within-Run precision (NCCLSEP5-A):	SWR 0.070 g/dL, CV 0.6 %
Total precision (NCCLS EP5-A):	ST 0.162 g/dL, CV 1.4 %
Hemoglobin/high (15.7 g/dL):Within-Run precision (NCCLSEP5-A):	SWR 0.087 g/dL, CV 0.5 %
Total precision (NCCLS EP5-A):	ST 0.174 g/dL, CV 1.1 %
Between-Day ImprecisionSingle observation, 20 days	8.0 g/dL: SD 0.111 g/dL, CV 1.4 %11.8 g/dL: SD 0.176 g/dL, CV 1.5 %15.7 g/dL: SD 0.179 g/dL, CV 1.1 %
Regression line and correlationcoefficients compared to CLSI H15-A3reference method (g/dL), venous blood	Y= 0.2929 + 1.0086XR2=0.9955N=100, duplicate measurementsRange 7.6g/dL to 24.2 g/dL

(2) Clinical Tests Submitted: (none)

(3) Conclusions from Tests:

As described in (b)(1) above, all of the testing demonstrated that the modified cuvettes number 3000-3012-0765 for the Hemo Control Hemoglobin Measurement System are substantially equivalent based upon design and function.

ు :

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

EKF-diagnostic GmbH c/o Mr. Stephen Gorski, President Imagenix, Inc S65 W35739 Piper Road Eagle. WI 53119

MAR 0 4 2011

Re: K110393

Trade/Device Name: EKF diagnostic Hemo_Control Hemoglobin Measurement System Regulation Number: 21 CFR §864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code(s): GKR, KHG Dated: January 31, 2011 Received: February 11, 2011

Dear Mr. Gorski:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls). 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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 - Mr. Stephen Gorski

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 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

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Section 4 - Indications for Use Statement

Indications for Use Statement

K110393 510(k) Number: Unknown

Device Name: Hemo-Control Hemoglobin Measurement System

Indications for Use:

The Hemo-Control 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.

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 Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro DiagnosticDevice Evaluation and Safety

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).