(38 days)
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No
The provided text describes a quantitative hemoglobin analyzer system using a specific analyzer and microcuvettes. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the analytical system components and their intended use.
No
This device is for the quantitative determination of hemoglobin in blood, which is a diagnostic function, not a therapeutic one.
Yes
The text explicitly states, "The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only," indicating that the system (analyzer and microcuvettes) is used for diagnostic purposes.
No
The description explicitly states the device is an "analytical system" composed of an "analyzer" (hardware) and "microcuvettes" (reagents/consumables), which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states: "The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only."
- Intended Use: The intended use is the "Quantitative determination of hemoglobin in capillary, venous and arterial whole blood." This is a measurement performed on a biological sample (blood) outside of the body, which is the definition of an in vitro diagnostic test.
- System Components: The description highlights that the reagents/microcuvettes and the analyzer form an analytical system used for this determination. This is typical of IVD systems.
N/A
Intended Use / Indications for Use
The HemoCue® Hb 201+ System is intended for: Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201+ analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.
Product codes
GKR
Device Description
The HemoCue® Hb 201+ System is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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/1 description: The image contains a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, creating a sense of depth and movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HemoCue, Incorporated c/o R.J. Slomoff 9229 Cranford Drive Potomac, Maryland 20854
AUG 2 5 2003
K032203 Re:
Trade/Device Name: HemoCue® Hb 201+ System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: July 14, 2003 Received: July 31, 2003
Dear Mr. Slomoff:
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
2
K032203 510(k) Number:
Device Name: HemoCue® Hb 201+ System
Indications For Use:
Quantitative determination of hemoglobin in capillary, venous and arterial whole blood.
The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes.
The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences.
The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jauphin Bautista
Division Sigh-Off
(Optional Format 3-10-98)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032203