(21 days)
Not Found
No
The device description and performance studies focus on a photometric method using chemical reactions and the Lambert-Beers Law, with no mention of AI or ML. The modification is limited to the microcuvettes.
No
The device is for in vitro diagnostic use, intended for quantitative determination of hemoglobin, which is a diagnostic function, not a therapeutic one.
Yes
The text explicitly states, "The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood." and "For In Vitro Diagnostic Use Only", indicating its use in diagnosing health conditions.
No
The device description explicitly states the system is comprised of a photometer (hardware) and microcuvettes (hardware with reagents). The 510(k) is for a modification to the microcuvettes, which are physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For In Vitro Diagnostic Use Only" in the Intended Use / Indications for Use section.
- The device is intended for the quantitative determination of hemoglobin in blood, which is a test performed on samples taken from the body, characteristic of IVD devices.
- The device description details the use of microcuvettes with dry reagents and a chemical reaction to measure hemoglobin, which is an in vitro process.
N/A
Intended Use / Indications for Use
The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.
For In Vitro Diagnostic Use Only
Product codes (comma separated list FDA assigned to the subject device)
GKR, KHG
Device Description
The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.
The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light.
The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.
The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).
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
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Tests:
Changes were evaluated in accordance with the sponsor's Design Control and Risk Management processes. Laboratory testing of the modified cuvettes was performed on venous blood samples per CLSI H15-A3. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood. A precision evaluation was performed on 100 samples. The following results were obtained with respect to the reference method:
Hemoglobin/low (8.0 g/dL):
Within-Run precision (CLSI EP5-A): SWR 0.058 g/dL, CV 0.7 %
Total precision (CLSI EP5-A): ST 0.122 g/dL, CV 1.5 %
Hemoglobin/normal (11.8g/dL):
Within-Run precision (NCCLS EP5-A): SWR 0.070 g/dL, CV 0.6 %
Total precision (NCCLS EP5-A): ST 0.162 g/dL, CV 1.4 %
Hemoglobin/high (15.7 g/dL):
Within-Run precision (NCCLS EP5-A): SWR 0.087 g/dL, CV 0.5 %
Total precision (NCCLS EP5-A): ST 0.174 g/dL, CV 1.1 %
Between-Day Imprecision (Single observation, 20 days):
8.0 g/dL: SD 0.111 g/dL, CV 1.4 %
11.8 g/dL: SD 0.176 g/dL, CV 1.5 %
15.7 g/dL: SD 0.179 g/dL, CV 1.1 %
Regression line and correlation coefficients compared to CLSI H15-A3 reference method (g/dL), venous blood:
Y= 0.2929 + 1.0086X
R2=0.9955
N=100, duplicate measurements
Range 7.6g/dL to 24.2 g/dL
Clinical Tests Submitted: (none)
Conclusions from Tests:
All of the testing demonstrated that the modified cuvettes number 3000-3012-0765 for the Hemo Control Hemoglobin Measurement System are substantially equivalent based upon design and function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for precision, accuracy, and regression data.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | EKF-diagnostic GmbH
Ebendorfer Chaussee 3
Barleben / Magdeburg
D-19061 Germany
Tel.: +49-(0)39203-785-0
Fax: +49-(0)39203-785-16 |
|-----|-----|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact Person: | Mr. Ronny Friedrich
ronny.friedrich@EKF-diagnostic.de |
| | | Position/Title: | Quality Manager |
| | | Date of Preparation: | January 31, 2011 |
| | (2) | Trade Name: | Hemo_Control Hemoglobin
Measurement System: Modification to
Hemo_Control Microcuvettes |
| | | | Common/Classification Name: AUTOMATED HEMOGLOBIN SYSTEM |
| | | Product Code(s): | GKR, 21 CFR §864.5620
KHG, 21 CFR §864.7500 |
| | | Class: | Class II |
| | (3) | Predicate Device(s): | Hemo_Control Hemoglobin
Measurement System (K031898)
Modification To Stanbio Laboratory
Hemopoint H2 Hemoglobin
Measurement System (K081719) |
| | | Reason for Submission: | Device Modification |
| | | | |
(4) Description of Device:
・・
The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.
The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control
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Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light. 1
The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.
The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).
(5) Intended use:
The intended use, the quantitative determination of hemoglobin in blood, is unchanged by the cuvette modification.
Indications for Use:
The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported 3 -
For In Vitro Diagnostic Use Only
(6) Technological Characteristics:
The scope of the change in this 510(k) is limited to the microcuvette geometric dimensions. The geometry of the microcuvette is modified for easier filling of the microcuvette and to minimize possible air bubbles forming by implementing a symmetrical sample inlet.
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No changes to the Hemo_Control Hemoglobin Measurement System instrument hardware or software are considered in this special 510(k) - no changes to the instrument are required to utilize the modified cuvette.
Non-Clinical Tests Submitted: (b) (1)
Changes were evaluated in accordance with the sponsor's Design Control and Risk Management processes. Laboratory testing of the modified cuvettes was performed on venous blood samples per CLSI H15-A3. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood. A precision evaluation was peformed on 100 samples. The following results were obtained with respect to the reference method:
| | HEMO_CONTROL modified microcuvette
measured in HEMO_CONTROL device |
|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Hemoglobin/low (8.0 g/dL)
Within-Run precision (CLSI
EP5-A): | SWR 0.058 g/dL, CV 0.7 % |
| Total precision (CLSI EP5-A): | ST 0.122 g/dL, CV 1.5 % |
| Hemoglobin/normal (11.8g/dL)
Within-Run precision (NCCLS
EP5-A): | SWR 0.070 g/dL, CV 0.6 % |
| Total precision (NCCLS EP5-A): | ST 0.162 g/dL, CV 1.4 % |
| Hemoglobin/high (15.7 g/dL):
Within-Run precision (NCCLS
EP5-A): | SWR 0.087 g/dL, CV 0.5 % |
| Total precision (NCCLS EP5-A): | ST 0.174 g/dL, CV 1.1 % |
| Between-Day Imprecision
Single observation, 20 days | 8.0 g/dL: SD 0.111 g/dL, CV 1.4 %
11.8 g/dL: SD 0.176 g/dL, CV 1.5 %
15.7 g/dL: SD 0.179 g/dL, CV 1.1 % |
| Regression line and correlation
coefficients compared to CLSI H15-A3
reference method (g/dL), venous blood | Y= 0.2929 + 1.0086X
R2=0.9955
N=100, duplicate measurements
Range 7.6g/dL to 24.2 g/dL |
(2) Clinical Tests Submitted: (none)
(3) Conclusions from Tests:
As described in (b)(1) above, all of the testing demonstrated that the modified cuvettes number 3000-3012-0765 for the Hemo Control Hemoglobin Measurement System are substantially equivalent based upon design and function.
ు :
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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
EKF-diagnostic GmbH c/o Mr. Stephen Gorski, President Imagenix, Inc S65 W35739 Piper Road Eagle. WI 53119
MAR 0 4 2011
Re: K110393
Trade/Device Name: EKF diagnostic Hemo_Control Hemoglobin Measurement System Regulation Number: 21 CFR §864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code(s): GKR, KHG Dated: January 31, 2011 Received: February 11, 2011
Dear Mr. Gorski:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 - Mr. Stephen Gorski
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m chan
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
Indications for Use Statement
K110393 510(k) Number: Unknown
Device Name: Hemo-Control Hemoglobin Measurement System
Indications for Use:
The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.
For In Vitro Diagnostic Use Only
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Division Sign-Off |
| Office of In Vitro Diagnostic |
| Device Evaluation and Safety |