(67 days)
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No
The device description and performance studies focus on spectrophotometric measurement and standard analytical performance metrics, with no mention of AI/ML algorithms or training/test data.
No.
This device is an in-vitro diagnostic device used for quantitative determination of hemoglobin concentrations in human blood, not for therapeutic purposes.
Yes
The text explicitly states "For in-vitro diagnostic use only" and describes the device as intended for the "quantitative determination of hemoglobin (Hb) concentrations in human blood," which is a diagnostic measurement.
No
The device description explicitly states that the Hemo Control system consists of a photometer/analyzer (a hardware component) and microcuvettes, which are also physical consumables. The process involves inserting a filled microcuvette into the photometer for measurement. This clearly indicates the device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in-vitro diagnostic use only."
- Intended Use: The device is intended for the "quantitative determination of hemoglobin (Hb) concentrations in human blood." This is a diagnostic measurement performed on a biological sample (blood) outside of the body.
- Device Description: The description details a system that analyzes a blood sample using a chemical reaction and spectrophotometry to determine a diagnostic parameter (hemoglobin concentration).
- Components: The system includes a photometer/analyzer and microcuvettes, which are typical components of IVD devices used for analyzing biological samples.
- Quality Control: The mention of control solutions and a control cuvette for verifying measurement accuracy further supports its use in a diagnostic setting where quality control is essential.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
For in-vitro diagnostic use only.
Product codes
GKR
Device Description
Hemo Control consists of the Hemo Control photometer / analyzer and the Hemo Control Hemoglobin Microcuvettes, its accessories and consumables (i.e. Control Solution Hb-con).
The Hemo Control photometer / analyzer is a semi-automated, spectrophotometric instrument, which provides instant quantitative total hemoglobin results.
Using the reagent filled microcuvette a small amount of arterial, venous or capillary blood is taken up by capillary action. The filled microcuvette is inserted into the Hemo Control photometer. The color produced by chemical reaction in the microcuvette is measured and the Hb value is displayed.
The measurement accuracy of the Hemo Control Hemoglobin Measurement System can be verified by use of Hb-con control solution, a quality control material with pre-determined hemoglobin concentration. As a second quality control measurement, the control cuvette as a physical standard is used for a comfortable and cheap check of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Analytical Performance:
a. Precision:
Hemoglobin/Low (107 g/L) – Within Run (CV): 0.8%, Total (CV): 1.0%, Single Observation 20 days (CV): 0.9%
Hemoglobin/Normal (129 g/L) – Within Run (CV): 0.6%, Total (CV): 1.0%, Single Observation 20 days (CV): 0.8%
Hemoglobin/High (173 g/L) – Within Run (CV): 0.6%, Total (CV): 1.1%, Single Observation 20 days (CV): 1.0%
b. Linearity/assay reportable range: 0 - 25.6 g/dL
c. Traceability (controls, calibrators, or method): Device calibrated against NCCLS reference method
Comparison studies:
a. Method comparison:
Comparison to NCCLS Reference Method: y=1.0064x + 0.0234, r=0.0076, n=174
Comparison to HemoCue hemoglobin measurement system y=1.0005x - 0.2334, r=0.9962, n=286
Comparison of Hemo Control Cuvettes in HemoCue y=0.9855x + 0.139, r=0.998, n=286
b. Matrix comparison:
Capillary samples, 4 sites: y=0.96x + 0.3742, r=0.8256, n=275
Arterial samples, 1 site: y=0.9868x - 0.0285, r=0.998, n=10
Expected values/Reference range:
Women: 12.0 – 16.0 g/dl
Men: 13.0 – 17.5 g/dl
Children, depending on age: 9.0 -24 g/dl
Key Metrics
Precision (CV): 0.8% (low Hb), 0.6% (normal Hb), 0.6% (high Hb) within run.
Linearity/assay reportable range: 0 - 25.6 g/dL.
Comparison to NCCLS Reference Method: r=0.0076.
Comparison to HemoCue hemoglobin measurement system: r=0.9962.
Comparison of Hemo Control Cuvettes in HemoCue: r=0.998.
Capillary samples comparison: r=0.8256.
Arterial samples comparison: r=0.998.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
June 12, 2020
EKF-diagnostic GmbH Andrew Rutter Global Head, Ouality Assurance & Regulatory Affairs Ebendorfer Chaussee 3 Barleben, 39179 Germany
Re: K200909
Trade/Device Name: Hemo Control Regulation Number: 21 CFR 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: Class II Product Code: GKR Dated: April 3, 2020 Received: April 6, 2020
Dear Andrew Rutter:
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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200909
Device Name Hemo Control
Indications for Use (Describe)
Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
For in-vitro diagnostic use only.
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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510k Summary
| Introduction | According to the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter | EKF-diagnostic GmbH |
| Ebendorfer Chaussee 3 | |
| 39179 Barleben | |
| Germany | |
| Contact Person: | Andrew Rutter |
| Phone: +44 2920 710570 | |
| Fax: +44 2920 705715 | |
| Email: andrewrutter@ekfdiagnostics.com | |
| Secondary Contact: | Karen Golomb |
| Phone: | |
| Fax: | |
| Email: karengolomb@ekfdiagnostics.com | |
| Date Prepared: | 24th April 2020 |
| Device Name: | Proprietary names: |
| Hemo Control | |
| Common names: As above. | |
| Classification: 21CFR864.5620 (Class II, Automated hemoglobin system) | |
| Product Code: GKR | |
| Device Descriptions: Hemo Control consists of the Hemo Control photometer / analyzer and the Hemo Control Hemoglobin Microcuvettes, its accessories and consumables (i.e. Control Solution Hb-con). | |
| The Hemo Control photometer / analyzer is a semi-automated, spectrophotometric instrument, which provides instant quantitative total hemoglobin results. | |
| Using the reagent filled microcuvette a small amount of arterial, venous or capillary blood is taken up by capillary action. The filled microcuvette is inserted into the Hemo Control photometer. The color produced by chemical reaction in the microcuvette is measured and the Hb value is displayed. | |
| The measurement accuracy of the Hemo Control Hemoglobin Measurement System can be verified by use of Hb-con control solution, a quality control material with pre-determined hemoglobin concentration. |
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| | As a second quality control measurement, the control cuvette as a
physical standard is used for a comfortable and cheap check of the
device. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices: | EKF Diagnostic Hemo Control Hemoglobin Measurement System |
| Predicates 510(k): | K031898 |
| Special Conditions
for Use: | For in vitro diagnostic use.
Rx Only |
| Special instrument
Requirements: | None |
| Intended Use: | Hemo Control is intended to be used for the quantitative determination
of hemoglobin (Hb) concentrations in human blood. |
| | The Hemo Control Hemoglobin Microcuvettes are intended to be used
with the Hemo Control photometer for the quantitative determination of
hemoglobin (Hb) concentrations in human blood. |
For in-vitro diagnostic use only.
Comparison with predicate:
Similarities and differences compared to the chosen predicate device:-Hemo Control Hemoglobin System (K031898)
| Predicate Device: | Candidate Device: | |
|---|---|---|
| Hemo Control | Hemo Control | |
| Model number | 3000-0031-6901 | 3040-0010-0218 |
| Intended Use: | Quantitative determination of | |
| hemoglobin | Quantitative determination of | |
| hemoglobin | ||
| Indications for Use | The Hemo Control Hemoglobin | |
| Measurement System is intended | ||
| to be used for the quantitative | ||
| determination of hemoglobin (Hb) | ||
| concentrations in human blood. | Hemo Control is intended to be used | |
| for the quantitative determination of | ||
| hemoglobin (Hb) concentrations in | ||
| human blood. | ||
| Analyte | Hemoglobin | Hemoglobin |
| Sample requirements | Venous, capillary or arterial blood | Venous, capillary or arterial blood |
| Methodology | Hem-azide methemoglobin | |
| Hct-Estimation from hemoglobin | Hem-azide methemoglobin | |
| Hct-Estimation from hemoglobin |
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| Functionality | Data transfer only | Additional data management
functionality |
|---------------|--------------------|---------------------------------------------|
| Accessory | None | Optional Add Pack Hemo Control DM |
Performance Characteristics
Hemo Control
Analytical Performance
a. Precision:
| | Within Run
(CV) | Total
(CV) | Single Observation
20 days
(CV) |
|--------------------------------|--------------------|---------------|---------------------------------------|
| Hemoglobin/Low
(107 g/L) | 0.8% | 1.0% | 0.9% |
| Hemoglobin/Normal
(129 g/L) | 0.6% | 1.0% | 0.8% |
| Hemoglobin/High
(173 g/L) | 0.6% | 1.1% | 1.0% |
b. Linearity/assay reportable range: 0 - 25.6 g/dL
c. Traceability (controls, calibrators, or method): Device calibrated against NCCLS reference method
Comparison studies
- a. Method comparison
Comparison to NCCLS Reference Method: y=1.0064x + 0.0234, r=0.0076, n=174
Comparison to HemoCue hemoglobin measurement system y=1.0005x - 0.2334, r=0.9962, n=286
Comparison of Hemo Control Cuvettes in HemoCue y=0.9855x + 0.139, r=0.998, n=286
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- b. Matrix comparison Capillary samples, 4 sites: y=0.96x + 0.3742, r=0.8256, n=275
Arterial samples, 1 site: y=0.9868x - 0.0285, r=0.998, n=10
Expected values/Reference range Based on literature references
Women: 12.0 – 16.0 g/dl Men: 13.0 – 17.5 g/dl Children, depending on age: 9.0 -24 g/dl
Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.