The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.

Device Description

The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.

AI/ML Overview

The HemoCue Glucose 201 RT system is designed for quantitative determination of glucose in whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets in mg/dL or %). Instead, it generally states that the device provides "clinical results comparable to other test methods." This implies that the acceptance criteria are met if the new device's performance is demonstrably equivalent or non-inferior to the legally marketed predicate device (HemoCue Glucose 201 system, K020935) and other established test methods.

Acceptance Criteria (Implied)	Reported Device Performance
Performance comparable to the predicate device and other test methods in clinical laboratory and point-of-care settings.	"Studies were conducted... to demonstrate the performance of the HemoCue Glucose 201 RT system and that the intended user can easily operate the system and obtain results as expected.""...provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices."
Ease of operation by intended users.	"...intended user can easily operate the system..."
Accurate quantitative determination of glucose in whole blood.	"The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.""The calibration... is traceable to the ID GC-MS method."
Suitable for professional use.	"For professional use only." (Stated in Intended Use)
In Vitro Diagnostic use only.	"For In Vitro Diagnostic use only." (Stated in Intended Use)

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

The document does not specify the exact sample size used for the test set. It mentions:

"Studies were conducted in-house, in clinical laboratory settings and point of care centers..."

This indicates that the data was collected from various settings, suggesting a prospective data collection approach from potentially multiple sites. The country of origin is not explicitly stated, but given the submitter is HemoCue AB in Sweden, and the contact is HemoCue, Inc. in the US, it's plausible the studies were conducted in both Europe and the US.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. Given it's a glucose measurement device, the "ground truth" would likely be established by a reference method rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. For a glucose measurement device, the primary validation involves comparison to a reference standard rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study is not applicable to this type of device (a glucose measurement system). MRMC studies typically involve human readers interpreting images or data, which is not the primary function of a glucose meter. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported.

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

Yes, this device inherently functions in a standalone (algorithm only) manner. The HemoCue Glucose 201 RT system, consisting of the analyzer and microcuvettes, performs the measurement and calculates the glucose level without direct human interpretation of raw data. The user only provides the blood sample and
reads the displayed result. The description of the device operation and the fact that "the transmittance is measured and the absorbance and glucose level is calculated" within the analyzer confirms its standalone operation.

7. The Type of Ground Truth Used

The ground truth used for this device is based on a traceable reference method:

"The calibration of the HemoCue Glucose 201 RT system is traceable to the ID GC-MS method."

ID GC-MS (Isotope Dilution Gas Chromatography-Mass Spectrometry) is a highly accurate and precise reference method for glucose determination, often considered a "gold standard."

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. For an in vitro diagnostic device like this, the "training" (calibration) is typically part of the manufacturing process or device design. The device is "factory calibrated" and "needs no further calibration."

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

Given that the device is "factory calibrated" and its calibration is "traceable to the ID GC-MS method," the ground truth for establishing the device's inherent measurement characteristics and calibration was likely established using samples analyzed by the ID GC-MS reference method. These known concentrations would have been used during the manufacturing and calibration process of the analyzers.

Summary

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K060765

SEP -6 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(800) 881-1611 x110 (Telephone)(949) 859-3066 (FAX)allan@hemocue.com
Date of Preparation:	March 17, 2006
Proprietary Name:	HemoCue Glucose 201 RT system
Classification Name:	Glucose Dehydrogenase, Glucose test system (21 CFR §862.1345), Product code: LFR
Common Name:	HemoCue Glucose 201 RT system
Equivalent to:	HemoCue AB claims substantial equivalence to the current legallymarketed HemoCue Glucose 201 system (K020935)

Description

Intended use

Technological Characteristics

The technological characteristics for HemoCue Glucose 201 RT system are equivalent to the predicate device. The system consists of an analyzer together with microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. A

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blood sample of approximatly 4 µL is drawn into the cavity by capillary action. The chemical reaction in the cavity of the HemoCue Glucose 201 RT microcuvettes has two phases, hemolysis and the glucose reaction. The glucose reaction is a modified glucose dehydrogenase method in which a tetrazolium salt (MTT) is used to obtain a quantification of glucose in visible light. B-D-glucose is transformed to B-D-glucose using mutarotase. Glucose dehydrogenase acts as a catalyst for the oxidation of B-D-glucose, to form NADH, which in the presence of diaphorase produces a colored formazan with MTT. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated. The calibration of the HemoCue Glucose 201 RT system is traceable to the ID GC-MS method. The HemoCue Glucose 201 RT is factory calibrated and needs no further calibration.

Claim	Similarities
Intended use	The HemoCue Glucose 201 RT and HemoCue Glucose 201 systemsare designed for quantitative determination of glucose in wholeblood (capillary, venous or arterial blood). Both devices are forprofessional use only. Both devices are for In Vitro Diagnostic useonly.
Test principle	Modified glucose dehydrogenase reaction
Result	Quantitative
Positioning	Point of Care
Operatingtemperature	59°F - 86°F(15°C - 30°C)
Labeling	Equal Directions For Use
Labelingexpected results	Fasting glucose values (reference interval): Plasma glucose, adults74-106 mg/dL (4.5-5.9 mmol/L).For diagnosis of diabetes mellitus, follow local recommendations oruse the following value according to WHO and ADA: Fastingplasma glucose, capillary or venous ≥126 mg/dL (≥7.0 mmol/L).
Quality controltesting	No external quality control testing is necessary. The systems have aninternal self-test.

Assessment of Performance

Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Glucose 201 RT system and that the intended user can easily operate the system and obtain results as expected.

Conclusion

The HemoCue Glucose 201 RT system is a convenient method for measuring blood glucose 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HemoCue AB c/o Mr. Allan White Quality System Manager HemoCue, Inc. 40 Empire Dr. Lake Forest, CA 92630-2244

SEP - 6 2006

Re: K060765

Trade/Device Name: HemoCue® Glucose 201 RT system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: August 14, 2006 Received: August 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 (QS) regulation (21 CFR Part 820).

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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.

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,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K060765

Device Name: HemoCue® Glucose 201 RT 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060765

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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.