(97 days)
The Hemo Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3011-050 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.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested.
The document is an FDA 510(k) clearance letter for the EKF-diagnostic Hemo Control Hemoglobin Measurement System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test or training sets.
- Information on data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
This kind of detailed study information is typically found in the 510(k) submission itself or in scientific publications, not in the FDA's clearance letter.
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SEP 2 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EKF Diagnostic GmbH c/o Mr. Stephen Gorski Submission Correspondent S65 W 35739 Piper Road Eagle, Wisconsin 53119
Re: K031898
Trade/Device Name: EKF-diagnostic Hemo Control Hemoglobin Measurement System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR, KHG Dated: June 16, 2003 Received: July 1, 2003
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
EKF-diagnostic Hemo Control Hemoglobin Measurement System Device Name:
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 3000-3011-050 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.
Josephine Bautista
Division Sigh-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031898
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use
§ 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).