(31 days)
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.
Not Found
This document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. While it generally refers to performance, it does not provide detailed acceptance criteria and a study demonstrating the device meets those criteria in the way a clinical study report would.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document only states the device is "substantially equivalent" to legally marketed predicate devices. It does not list specific performance metrics or their acceptance thresholds.
- Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or its origin.
- Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment details are absent.
- Adjudication method for the test set: No test set means no adjudication method described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The HemoCue Hb 201 DM System is an automated hemoglobin system, inherently operating in a standalone manner for measurement, but the document doesn't detail performance studies.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on how ground truth was established for any performance comparison.
- The sample size for the training set: There is no mention of a "training set" as this is a medical device clearance, not an AI model approval with a distinct training phase.
- How the ground truth for the training set was established: Not applicable, as no training set is discussed.
Information that can be inferred or directly stated from the document:
- Device Name: HemoCue® Hb 201 DM System
- Intended Use: Quantitative determination of hemoglobin in capillary, venous, and arterial whole blood.
- Regulatory Status: Cleared by FDA via 510(k) as substantially equivalent (K041234).
- Nature of the device: An automated hemoglobin system using a specific analyzer (HemoCue® Hb 201 DM Analyzer) and microcuvettes (HemoCue® Hb 201 Microcuvettes).
To answer the requested questions about acceptance criteria and study details, a different type of document, such as a clinical study report or detailed device validation report, would be required. The provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence, but it does not delve into the specifics of performance studies as requested.
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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
§ 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).