The Hemocue® Hbalc 501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The test is for prescription use as an aid in the management of diabetes.

Device Description

The Hemocue® HbA1c 501 M Glycosylated Hemoglobin test system measures Hemoglobin A 1c in venous and capillary whole blood. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system includes Analyzer. Test cartridge, Check cartridges(Monthly and Daily), Thermal printer, Barcode scanner, PC cable and fan filter. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c(HbA1c, %) in human whole blood.

The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin Alc, with a sampling area for blood collection.

The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.

The blood sample (4uL) is collected at the sampling area of the reagent pack, which is then inserted into the cartridge, where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.

The reagent pack containing the blood sample is inserted in Hemocue® HbA1c 501 Analyzer (in which the cartridge has been placed). The cartridge is automatically rotated, placing the blood sample in the measuring zone. The total hemoglobin is photometrically measured by the diffused reflectance of the optical sensor composed of both a LED (Light Emitting Diode) and a PD (Photo Diode). The assembled cartridge is rotated and the rinsing solution washes out non-glycated hemoglobin from the blood sample, enabling photomectical measurement of glycated hemoglobin.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System. While it states that "Test results showed substantial equivalence" for clinical performance, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CLOVER A1c The Glycosylated Hemoglobin Monitoring System, K082275) based on similarities in intended use, operating principle, materials, use environment, shelf life, and calibration method, along with a statement that verification, validation, and testing activities were conducted and passed.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Specific quantitative acceptance criteria (e.g., accuracy, precision targets)	Not provided in the text. The text only states that a "clinical performance evaluation" was conducted and "Test results showed substantial equivalence."
Predetermined Pass/Fail criteria for non-clinical tests	"The device passed all of the tests based on pre-determined Pass/Fail criteria." (Specific criteria not detailed.)
Substantial Equivalence to Predicate Device (CLOVER A1c, K082275)	"The HemoCue® HbA1c501System is as safe, as effective and performs as well as the legally marketed predicate device, CLOVER A1c TM System (K082275)." (This is the overarching conclusion rather than a specific performance metric.)

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The text mentions "clinical performance evaluation" but does not give a sample size.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Method of establishing ground truth: Not specified.

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

Adjudication Method: Not specified.

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:

MRMC Study: No, this device is a stand-alone analytical instrument for measuring HbA1c, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI is not applicable.

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

This device is an in vitro diagnostic device that quantitatively measures HbA1c. Its performance is its standalone performance. The "clinical performance evaluation" assessed how accurately the device measures HbA1c in blood samples.

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

Type of Ground Truth: Not explicitly stated. For HbA1c measurements, the "ground truth" would typically be established by a reference method of HbA1c measurement (e.g., HPLC) recognized as highly accurate, against which the new device's measurements are compared.

8. The sample size for the training set:

Sample Size (Training Set): Not applicable for this type of medical device which is an in vitro diagnostic instrument for directly measuring a biomarker. The device relies on a chemical/optical detection system, not a machine learning algorithm that requires a training set.

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

Training Set Ground Truth: Not applicable, as there is no training set for a machine learning model.

In summary: The provided text is a high-level 510(k) summary focusing on substantial equivalence to a predicate device for an HbA1c monitoring system. It does not contain the detailed study results, specific acceptance criteria, or methodological specifics typically found in a full efficacy study report. The key information provided is that a clinical performance evaluation was conducted and deemed "substantially equivalent," and non-clinical tests passed predetermined criteria.

Summary

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K 121366

SEP 7 2012

Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System Special 510(k) for In Vitro Diagnostic Device

IV. 510(k) Summary

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: April/24/2012

1. Submission Sponsor

	Submitter
NameAddress	Infopia Co.,Ltd.891 Hogye-dong, Dongan-Gu, Anyang, Kyunggi,431-080, Korea
Phone	Phone: +82-31-460-0300
Fax	Fax: +82-31-460-0401
Companycontact	YJ Park

1. Submission Correspondent
  Official Correspondent for Infopia Co., Ltd. Maria Griffin mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 TEL: (516) 482-9001

Device

Trade Name: Hemocue® HbA1c 501™ Glycosylated Hemoglobin test system
· Classification Name: Glycosylated Hemoglobin test system
· Classification regulation: 21 CFR 864.7470
· Product Code: LCP

Predicate Device:

CLOVER A Ic The Glycosylated Hemoglobin Monitoring System (K082275) Infopia Co., Ltd.

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Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System Special 510(k) for In Vitro Diagnostic Device

5. Description:

The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin Alc, with a sampling area for blood collection.

Indications for use:

The HemoCue® HbA1c501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbA Ic is used to monitor long-term glucose control in individuals with diabetes mellitus. HemoCue® Hba1c501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

The test is for prescription use as an aid in the management of diabetes.

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Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System

Special 510(k) for In Vitro Diagnostic Device

7. Comparison to the Cleared Device

The device appearance (Analyzer & Test cartridge) has been changed, and glucose module function has been removed. Display resolution &Graphic User Interface design has been improved. Other than these modifications, the modified meter has the following similarities to the cleared device:

· has the same intended use.
· uses the same operating principle,
· incorporates the same materials.
· adopts the same use environment and calibration method, and has the same shelf life.

8. Performance Data

Clinical: The clinical performance evaluation using the HemoCue® HbA1c501components were conducted for purpose of validating the professional accuracy. Test results showed substantial equivalence.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the HemoCue® HbA1c501System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

9. Conclusion

The conclusion drawn from the clinical and nonclinical tests is that the HemoCue® HbA1c501System is as safe, as effective and performs as well as the legally marketed predicate device, CLOVER A1c TM System (K082275).

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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 consists of a stylized eagle or bird-like figure with flowing lines, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular fashion around the bird symbol.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Infopia Co., Ltd. c/o Ms. Maria Griffin MDI consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021

SEP 7 2012

Re: K121366

Trade/Device Name: Hemocue HbA1c 501 Glycosylated Hemoglobin Monitoring System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: August 7, 2012 Received: August 9, 2012

Dear Ms. Griffin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad vice tor your avvice Evaluation and Safety at (301) 796-5450. Also, comation the office of in 11:00 Diagnoling by reference to premarket notification" (21 prease note the regulation entined, "Milion result and surveillance, please contact CDRH 3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Other of Surveinance and Drollion's o (Solice) of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely vours.

signature

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

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name: Hemocue® Hbalc 501 Glycosylated Hemoglobin Monitoring System

Indication For Use:

The test is for prescription use as an aid in the management of diabetes.

-Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Kattlenewis

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K121366

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).