(92 days)
Not Found
K/DEN not found for any reference device.
No
The summary describes a blood glucose test strip and meter, which are standard medical devices for measuring glucose levels and do not typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device measures glucose levels for diabetes management, which is diagnostic, not therapeutic.
Yes.
Explanation: The device "will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes," indicating its role in diagnosis and management of a disease.
No
The device is described as "blood glucose test strips" which are a physical component, not software. The description also mentions "blood glucose meters" which are hardware.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure glucose levels in fresh whole blood." This involves testing a biological sample (blood) outside of the body to obtain information about a person's health status (glucose levels for diabetes management). This is a core characteristic of an IVD.
- Sample Type: The device uses "fresh whole blood," which is a biological specimen.
- Purpose: The purpose is to "provide the user essential information for the proper management of diabetes," which is a medical condition.
These elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
Product codes
CGA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 098 Gaither Road Rockville MD 20850
Mr. Stephan C. Pearson Program Manager Chay Medical, LLC 66 Neptune Drive Groton, CT 06340
AUG 3 0 2002
Re: K021781
Trade/Device Name: Excelsior 3ul blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX blood glucose system, and Prestige IQ blood glucose system.
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA Dated: July 31, 2002 Received: August 2, 2002
Dear Mr. Pearson:
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/cdrb/dsmaldsmamain.html".
Sincerely yours,
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
2
510(k) Number (if known):
Ko21781
Device Name: Excelsior 3ul blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX blood glucose system, and Prestige IQ blood glucose system.
Indications For Use:
The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
Division of Clinical Va Devices 510(k) Number
Prescription Use
OR
Over-The-Counter Use
(PER 21 CFR 801.109)
(Optional Format 1-2-96)
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