(301 days)
No
The description explicitly states it is a "manual test that does not require electrical power or additional equipment" and mentions "Not Found" for mentions of AI, DNN, or ML, and training/test set descriptions.
No
The device is an in vitro diagnostic assay used to determine hemoglobin levels and estimate hematocrit, which are diagnostic purposes, not therapeutic.
Yes
The document explicitly states "The AnemoCheck is an in vitro diagnostic semi-quantitative assay".
No
The device description explicitly states it is a "manual test that does not require electrical power or additional equipment," indicating it is a physical assay, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the AnemoCheck is an "in vitro diagnostic semi-quantitative assay".
- Device Description: The description further clarifies that it's a "semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood". This describes a test performed on biological samples (whole blood) outside of the body, which is the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
Product codes
KHG
Device Description
The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
Intended User / Care Setting
point-of-care, clinical and doctor office laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision. Interference studies were conducted. Results indicated no significant effects on AnemoCheck test performance. The AnemoCheck is a convenient method for measuring total hemoglobin and calculated hematocrit (%) in whole blood. Test results are comparable to other test methods in clinical laboratory and point-of-care practices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hemocue® Hemoglobin Hb 201+ Analyzing System K032203, Siemens® Advia 2120i (K042251)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
Sanguina, LLC % Cathryn Cambria Consultant Cambria Regulatory Consulting, Inc. 5536 Trowbridge Drive Dunwoody, Georgia 30338
Re: K163215
Trade/Device Name: AnemoCheck Regulation Number: 21 CFR 864.7500 Regulation Name: Whole blood hemoglobin assays Regulatory Class: Class II Product Code: KHG Dated: July 13, 2017 Received: July 14, 2017
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 (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
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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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163215
Device Name AnemoCheck
Indications for Use (Describe)
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
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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K163215
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date : September 7, 2017
1. Submitter:
Sanguina, LLC 575 14th Street, NW Atlanta, GA 30318
2. Contact Name:
Cathryn N. Cambria 404-543-5909 ccambria@mindspring.com
3. Device:
Proprietary Name - AnemoCheck™ Common Name – Whole Blood Hemoglobin Determination
4. Classifications Names & Citations:
Product Code: KHG Regulation Number: 864.7500 Device Class: 2
న. Predicate Device:
Hemocue® Hemoglobin Hb 201+ Analyzing System K032203 Siemens® Advia 2120i (K042251)
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Device Description: 6.
The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.
7. Indication for use:
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in pointof-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).
8. Summary of Non-clinical Testing:
Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision. Interference studies were conducted. Results indicated no significant effects on AnemoCheck test performance.
9. Assessment of Performance:
The AnemoCheck is a convenient method for measuring total hemoglobin and calculated hematocrit (%) in whole blood. Test results are comparable to other test methods in clinical laboratory and point-of-care practices.
10. Conclusions:
The AnemoCheck™ is similar to other commercially available products based on the intended use, technology, and performance characteristics. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Sanguina, LLC concludes that AnemoCheck is safe and effective and substantially equivalent to the predicate(s).