(10 days)
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
The HemoCue Glucose 201 DM System consists of the HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes.
The provided text is a 510(k) clearance letter from the FDA for the HemoCue® Glucose 201 DM System. It primarily addresses regulatory approval and does not contain detailed information about the acceptance criteria or a specific study proving the device's performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to answer based only on the provided text, with significant limitations:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document is a regulatory clearance letter, not a detailed study report.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present in the provided document. The device in question is a glucose measurement system, not an AI-assisted diagnostic imaging tool, so an MRMC study with human readers assisting AI would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a "Glucose 201 DM System" which includes an analyzer and microcuvettes. This implies it is a standalone analytical system for measuring glucose. However, the document does not explicitly describe any standalone performance study details, only that it's a "quantitative determination of glucose."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a glucose test system, the ground truth would typically be established by a reference laboratory method (e.g., hexokinase method). However, this specific detail is not present in the provided document. The document mentions "quantitative determination of glucose in whole blood" and "instant blood glucose concentration," indicating a direct measurement, but not the gold standard used for comparison.
8. The sample size for the training set
This information is not present in the provided document.
9. How the ground truth for the training set was established
This information is not present in the provided document.
In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the HemoCue® Glucose 201 DM System based on substantial equivalence to a predicate device. It does not contain the detailed technical performance data, study design, or ground truth methodology that would typically be found in a clinical study report or a more comprehensive submission document.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that curve and taper towards the right, resembling a human figure in motion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 0 2004
HemoCue, Inc. c/o Mr. R. J. Slomoff Consultant to HemoCue, Inc. 9229 Cranford Drive Potomac, MD 20854
K041230 Rc:
Trade/Device Name: HemoCue® Glucose 201 DM System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test sytem Regulatory Class: Class II Product Code: LFR 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 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 gencral 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 practicc 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) 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 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,
Sean M. Cooper, US, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K041230 510(k) Number (if known):
HemoCue® Glucose 201 DM System Device Name:
Indications For Use:
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
Thereagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences.
The HemoCue Glucose 201 Microcuvettes are for in vitro use only.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Keun Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 041230
Page 1 of 1
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.