AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

Device Description

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL. AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user. AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

AI/ML Overview

The provided document is a 510(k) summary for the AnemoCheck Home device. It details a semi-quantitative, color-based test for hemoglobin levels from a finger stick, intended for home use by individuals over 18 with certain types of anemia.

Based on the provided text, here's an attempt to extract the requested information, acknowledging that some specific details (like exact sample sizes for training or specific expert qualifications for ground truth) might not be explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance:

The document broadly states that "Analytical testing of AnemoCheck Home versus the predicate device and comparator methods demonstrate substantial equivalence based on accuracy and precision." However, specific numerical acceptance criteria (e.g., a defined range for accuracy or precision) are not detailed in this summary. Similarly, the "reported device performance" in terms of specific quantitative results for accuracy and precision are also not explicitly provided in a table format. The text only offers a general conclusion that the test results are "comparable to other test methods."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Here's the rest of the information based on the provided document:

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

Test Set Sample Size: Not explicitly stated in the summary document. It mentions "analytical testing" and "test results in the hands of the intended user," implying a test set was used, but the size is not given.
Data Provenance: Not specified in the summary document. There is no mention of country of origin of the data, nor whether it was retrospective or prospective.

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

This information is not provided in the 510(k) summary. The document does not describe the process of establishing ground truth for the test set in detail. It refers to "clinical laboratory and point-of-care settings" as comparator methods, implying these settings generated the reference values, but not how experts specifically established "ground truth" labels for individual samples.

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

This information is not provided in the 510(k) summary. The document does not describe any specific adjudication method for the test set results or ground truth establishment.

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:

This device is a semi-quantitative, color-based test for hemoglobin levels. It is interpreted visually by the user based on a color card. There is no mention of an AI component or "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable here, and no effect size would be reported.

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

This is not an algorithm-only device. It is a physical, color-based test that requires user interpretation. Therefore, a "standalone algorithm-only" performance assessment is not applicable. The device's performance is inherently "human-in-the-loop" as the user matches the color to a card. The summary states, "Test results in the hands of the intended user, an untrained lay user, are comparable to other test methods."

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

The ground truth appears to have been established by "other test methods in clinical laboratory and point-of-care settings." This implies reference laboratory methods (e.g., automated hematology analyzers, or other established POCT devices with known accuracy) were used to determine the true hemoglobin levels for comparison. The specific type of "ground truth" (e.g., expert consensus on visual assessment, or a gold-standard lab test) is not explicitly detailed beyond "comparator methods."

8. The sample size for the training set:

The 510(k) summary for a medical device (especially one without a complex AI model) typically describes validation studies rather than "training sets" in the machine learning sense. This document describes "analytical testing" and "assessment of performance." The concept of a "training set" for the device's development (e.g., for calibrating the color card) is not explicitly detailed in terms of sample size within this summary.

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

As above, the concept of a "training set" as it relates to machine learning is not directly applicable or discussed in detail for this type of device in the provided summary. The process of how the color card was developed and correlated to specific hemoglobin values during the device's development (which could be considered analogous to "training") is not described in detail, but it would presumably involve comparing the device's color output to measured hemoglobin values from reference methods in a laboratory setting.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 29, 2023

Sanguina, Inc. Cathryn Cambria RA/QA Consultant 147 Technology Parkway Ste 100 Peachtree Corners, Georgia 30092

Re: K221508

Trade/Device Name: AnemoCheck Home Regulation Number: 21 CFR 864.7500 Regulation Name: Whole Blood Hemoglobin Assays Regulatory Class: Class II Product Code: KHG Dated: Mav 22, 2022 Received: May 24, 2022

Dear Cathryn Cambria:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Min Wu -S

Min Wu. Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K221508

Device Name AnemoCheck Home

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information complies with 21 CFR Part 807.92.

Date: 9/27/2023

1. Submitter: Sanguina, Inc. 147 Technology Parkway, Ste 100 Peachtree Corners, GA 30092, USA

2. Contact Name:

Cathryn N. Cambria 404-543-5909 ccambria@mindspring.com

Device: 3. Proprietary Name - AnemoCheck Home™ Common Name - Home Whole Blood Hemoglobin Determination

4. Classifications

Product Code: KHG - Whole blood hemoglobin assays Requlation section: CFR 864.7500 Device Classification: Class II

5. Substantial Equivalence:

HemoCue Hemoglobin 201+ System (K032203) AnemiaPro Self Screener (K042379)

6. Device Description:

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. See the simple diagram below for a summary of the steps (Figure 1). Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL.

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Image /page/4/Figure/0 description: The image is a title for a figure. The title says "Figure 1. Summary of AnemoCheck Home test use.". The title is written in a bold, sans-serif font. The title is centered on the image.

Image /page/4/Figure/1 description: This image shows the steps for performing a fingerstick blood test. First, perform a fingerstick and collect blood into the test cap. Next, mate the test cap and test body, and shake to make sure the blood is mixed for 5-10 seconds. Finally, wait 2 minutes, check the control window, and match the test result to the color card.

AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user.

AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

7. Indication for use:

8. Comparison of Technological Characteristics with the Predicate Device

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card for determination of hemoglobin (g/dL).

This method is also similar to the oxidation-reduction color-based method used in the HemoCue system.

9. Summary of Non-clinical Testing:

Analytical testing of AnemoCheck Home versus the predicate device and comparator methods demonstrate substantial equivalence based on accuracy and precision. Flex study and interference study results indicate no significant effects on AnemoCheck Home test performance.

10. Assessment of Performance:

AnemoCheck Home is a convenient method for measuring total hemoglobin in whole blood. Test results in the hands of the intended user, an untrained lay user, are comparable to other test methods in clinical laboratory and point-of-care settings.

11. Conclusions:

The AnemoCheck Home is similar to other 510(k) cleared and commercially available products based on the intended use, technology, and performance characteristics. In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Sanquina. Inc. concludes that AnemoCheck Home is safe and effective and substantially equivalent to the predicate(s).

Regulation Number and Section

§ 864.7500 Whole blood hemoglobin assays.

(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.