(12 days)
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 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.
HemoCue® Glucose 201 System
I am sorry, but the provided text from the FDA 510(k) summary for the HemoCue® Glucose 201 System does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and study proving device performance.
Specifically, this document is a letter from the FDA acknowledging the substantial equivalence of the device and its indications for use. It's a regulatory approval document, not the scientific study report itself.
Here's what I can and cannot provide based on the given text:
Information I CANNOT provide from this document:
- A table of acceptance criteria and the reported device performance: This detailed data is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and this type of study is typically for imaging devices, not glucose meters.
- If a standalone study was done: While the FDA review implies performance data was submitted, the details of such a study (standalone or otherwise) are not in this letter.
- The type of ground truth used: Not specified in this document. For a glucose meter, this would typically involve a laboratory reference method.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Information I CAN provide based on the given text:
- Device Name: HemoCue® Glucose 201 System
- Regulation Number/Name: 21 CFR 862.1345, Glucose test system
- Regulatory Class: Class II
To answer your request completely, I would need access to the actual HemoCue® Glucose 201 System's 510(k) submission summary or the underlying study reports, which are not provided in the text.
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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 depiction of an eagle or bird-like figure with three wave-like lines beneath it, all rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HemoCue, Inc. c/o Mr. R. J. Slomoff Consultant to HemoCue, Inc. 9229 Cranford Drive Potomac, MD 20854
APR 0 3 2002
K020935 Re:
Trade/Device Name: HemoCue® Glucose 201 System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: March 22, 2002 Received: March 22, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
KOZO935
HemoCue® Glucose 201 System Device Name:
Indications For Use:
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 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.
Albets Sati for kaiser Aziz
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K020935
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription USE
(Optional Format 3-10-98)
§ 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.