(67 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Hemo Control device:
Device: Hemo Control (automated hemoglobin system)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance |
|---|---|---|
| Precision | Within Run (CV) - Low (107 g/L) | 0.8% |
| Within Run (CV) - Normal (129 g/L) | 0.6% | |
| Within Run (CV) - High (173 g/L) | 0.6% | |
| Total (CV) - Low (107 g/L) | 1.0% | |
| Total (CV) - Normal (129 g/L) | 1.0% | |
| Total (CV) - High (173 g/L) | 1.1% | |
| Single Observation 20 days (CV) - Low (107 g/L) | 0.9% | |
| Single Observation 20 days (CV) - Normal (129 g/L) | 0.8% | |
| Single Observation 20 days (CV) - High (173 g/L) | 1.0% | |
| Linearity/Assay Range | Reportable range | 0 - 25.6 g/dL |
| 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 | |
| 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 |
The document does not explicitly state "acceptance criteria" but rather presents performance characteristics of the device. The reported performance is the demonstration that the device meets the implicit acceptance criteria for substantial equivalence to its predicate device. For example, the low %CV values for precision demonstrate acceptable reproducibility. The regression equations with r-values close to 1 and slopes close to 1 for method comparison studies demonstrate agreement with reference methods and predicate devices.
2. Sample Sizes Used for the Test Set and the Data Provenance
- Precision: The document provides Coefficient of Variation (CV) values for "Within Run," "Total," and "Single Observation 20 days" at low (107 g/L), normal (129 g/L), and high (173 g/L) hemoglobin concentrations. The specific number of samples or measurements for each of these precision studies is not explicitly stated in this summary, but typically, precision studies involve repeated measurements of control materials or patient samples.
- Method Comparison (NCCLS Reference Method): n = 174 samples
- Method Comparison (HemoCue hemoglobin measurement system): n = 286 samples
- Method Comparison (Hemo Control Cuvettes in HemoCue): n = 286 samples
- Matrix Comparison (Capillary samples): n = 275 samples
- Matrix Comparison (Arterial samples): n = 10 samples
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that this is a 510(k) submission from a German company (EKF-diagnostic GmbH) and involves comparison to established reference methods and other commercially available devices, it is highly likely these were prospective studies conducted in a clinical or laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This device is an automated hemoglobin system that measures a quantitative value (hemoglobin concentration). It does not rely on expert interpretation for its output. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or diagnostic classification (e.g., radiologists) is not relevant here.
The "ground truth" for method comparison studies is established by:
- NCCLS Reference Method: This refers to a standardized laboratory method (likely cyanmethemoglobin method, which is a gold standard for hemoglobin measurement). The reference method itself is the "ground truth."
- Predicate Device (HemoCue hemoglobin measurement system): This is another commercially available, cleared device that serves as a comparison standard.
4. Adjudication Method for the Test Set
Not applicable. Since the device produces a quantitative numerical output for hemoglobin concentration, there is no need for an adjudication method among experts. The "ground truth" is determined by the reference method or comparison device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) to assess the impact of AI assistance on their performance. The Hemo Control is an automated quantitative device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the analytical performance and method comparison studies described are inherently standalone performance studies. The Hemo Control device (photometer and microcuvettes) itself performs the measurement and provides the hemoglobin value. There is no "human-in-the-loop" interaction for interpreting the result, only for operating the device, taking the sample, and understanding the output.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation included:
- NCCLS Reference Method: A highly standardized, accepted laboratory method for hemoglobin measurement.
- Predicate Device Performance: Comparison against the performance of another legally marketed device (HemoCue hemoglobin measurement system).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This device operates based on spectrophotometric principles and chemical reactions, not on complex machine learning algorithms that require large training data sets in the typical sense. The fundamental physical and chemical principles are well-established.
The studies described (precision, linearity, method comparison, matrix comparison) are typically considered verification and validation studies performed after the device design is largely finalized, not for "training" an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for this device's operation. The device's calibration and performance are established against physical standards, reference methods, and quality control materials, which form its inherent "ground truth." Specifically, the device is calibrated against the NCCLS reference method, and its accuracy can be verified using Hb-con control solutions (quality control material with pre-determined hemoglobin concentration) and a control cuvette as a physical standard.
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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 GmbHEbendorfer Chaussee 339179 BarlebenGermany |
| Contact Person: | Andrew RutterPhone: +44 2920 710570Fax: +44 2920 705715Email: andrewrutter@ekfdiagnostics.com |
| Secondary Contact: | Karen GolombPhone: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 aphysical standard is used for a comfortable and cheap check of thedevice. | |
|---|---|
| Predicate Devices: | EKF Diagnostic Hemo Control Hemoglobin Measurement System |
| Predicates 510(k): | K031898 |
| Special Conditionsfor Use: | For in vitro diagnostic use.Rx Only |
| Special instrumentRequirements: | None |
| Intended Use: | Hemo Control is intended to be used for the quantitative determinationof hemoglobin (Hb) concentrations in human blood. |
| The Hemo Control Hemoglobin Microcuvettes are intended to be usedwith the Hemo Control photometer for the quantitative determination ofhemoglobin (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 ofhemoglobin | Quantitative determination ofhemoglobin |
| Indications for Use | The Hemo Control HemoglobinMeasurement System is intendedto be used for the quantitativedetermination of hemoglobin (Hb)concentrations in human blood. | Hemo Control is intended to be usedfor the quantitative determination ofhemoglobin (Hb) concentrations inhuman blood. |
| Analyte | Hemoglobin | Hemoglobin |
| Sample requirements | Venous, capillary or arterial blood | Venous, capillary or arterial blood |
| Methodology | Hem-azide methemoglobinHct-Estimation from hemoglobin | Hem-azide methemoglobinHct-Estimation from hemoglobin |
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| Functionality | Data transfer only | Additional data managementfunctionality |
|---|---|---|
| Accessory | None | Optional Add Pack Hemo Control DM |
Performance Characteristics
Hemo Control
Analytical Performance
a. Precision:
| Within Run(CV) | Total(CV) | Single Observation20 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.
§ 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).