(31 days)
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No
The provided text describes a quantitative hemoglobin analyzer system and its intended use, but contains no mention of AI or ML technologies.
No
The device is used for the quantitative determination of hemoglobin, which is a diagnostic function rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device is for "Quantitative determination of hemoglobin in capillary, venous and arterial whole blood," which is a diagnostic measurement.
No
The description explicitly states the device is an "analytical system" composed of a specially designed analyzer (hardware) and microcuvettes (reagents/consumables), which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "Quantitative determination of hemoglobin in capillary, venous and arterial whole blood." This indicates the device is used to measure a substance (hemoglobin) in a biological sample (blood).
- "The HemoCue® Hb 201 microcuvettes are for in vitro use only." This explicitly states that the microcuvettes, which are part of the system, are intended for use outside of a living organism.
- "The reagents/microcuvettes and the analyzer form an analytical system." This describes a system used for analysis of biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / 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 201 201 Analyzer. The HemoCue® Hb 201 DM System is used for the quantitative determination of hemoglobin in blood using specially designed analyzer, the HemoCue® Hb 201 DM Analyzer and specially designed microcuvettes, the HemoCue® Hb 201 Microcuvettes. The HemoCue Hb 201 DM 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 DM Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. The use of any other device in the HemoCue Hb 201 DM Analyzer except the HemoCue 201 Microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequence.
The HemoCue Hb 201 microcuvettes are for in vitro use only.
Product codes (comma separated list FDA assigned to the subject device)
GKR
Device Description
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 0 2004
Hemocue, Inc. c/o R.J. Slomoff Robert Joei Slomoff 9229 Cranford Drive Potomac, MD 20854
Re: K041234
Trade/Device Name: HemoCue® Hb 201 DM System Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR Dated: May 6, 2004 Received: May 10, 2004
Dear Mr. Slomoff:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bared in the 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 r ou may, aroney include 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 i lease be actives that I Drivination that your device complies with other requirements of the Act that I Dr Hab mace a and regulations administered by other Federal agencies. You must or any I catal statute and 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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manxoling of substantial equivalence of your device to a legally premarket notheadon: "The PDA miding of castinations of your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific information assume of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagnostic Device Development and be see and see and the ation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may outain other general mornational 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,
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HemoCue® Hb 201 DM System Device Name: _________________________________________________________________________________________________________________________________________________________________
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 201 201 Analyzer. The HemoCue® Hb 201 DM System is used for the quantitative determination of hemoglobin in blood using specially designed analyzer, the HemoCue® Hb 201 DM Analyzer and specially designed microcuvettes, the HemoCue® Hb 201 Microcuvettes. The HemoCue Hb 201 DM 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 DM Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. The use of any other device in the HemoCue Hb 201 DM Analyzer except the HemoCue 201 Microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequence.
The HemoCue Hb 201 microcuvettes are for in vitro use only.
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
510(k) K041234