(92 days)
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.
Not Found
This document is a 510(k) clearance letter for a blood glucose test strip, which falls under IVD (In Vitro Diagnostic) devices. For IVD devices, the acceptance criteria and study details are typically presented differently than for AI/ML-based diagnostic software. Instead of metrics like sensitivity, specificity, AUC, or reader studies, IVD device performance is usually evaluated based on accuracy against a reference method (e.g., laboratory analyzer), precision (repeatability, reproducibility), and interference studies.
Based on the provided text, there is no detailed information on acceptance criteria and a study report in the format typically requested for AI/ML devices. The document is primarily an FDA clearance letter and an "Indications For Use" statement. It confirms that the device is "substantially equivalent" to a legally marketed predicate device.
Therefore, many of the requested points for describing acceptance criteria and a study cannot be directly extracted from this document because it is not a study report.
However, I can infer some information based on the context of 510(k) submissions for IVD devices and the provided text:
1. A table of acceptance criteria and the reported device performance:
This information isn't explicitly in the provided text. For blood glucose meters and strips, typical acceptance criteria would involve accuracy metrics (e.g., certain percentage of results falling within specific ranges compared to a lab reference, or mean absolute relative difference - MARD), precision (coefficients of variation), and linearity. The "substantially equivalent" determination implies that the device met performance standards comparable to the predicate device.
2. Sample size used for the test set and the data provenance:
Not provided in this document. Studies for blood glucose meters typically involve a diverse set of patient samples with varying glucose levels.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For blood glucose meters, the "ground truth" is typically established by measurements from a central laboratory's reference analyzer, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of IVD device where ground truth is machine-determined (reference lab).
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:
Not applicable. This is not an AI/ML device, and there are no "human readers" interpreting results in the way an AI would assist a radiologist.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device (test strips) essentially operates in a "standalone" manner in that the chemical reaction on the strip and the meter's reading algorithm directly provide a result. There isn't an AI "human-in-the-loop" component in the traditional sense for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood glucose test strips, the ground truth is established by a laboratory reference method, typically a clinical chemistry analyzer with high accuracy and precision, such as a YSI glucose analyzer.
8. The sample size for the training set:
Not applicable in the context of AI/ML training. For IVD devices, development involves analytical studies (e.g., accuracy, precision, interference) and clinical studies. The "training set" concept doesn't directly apply in the same way.
9. How the ground truth for the training set was established:
Not applicable as there isn't a "training set" in the AI/ML sense. Ground truth for performance evaluation samples would be established via a laboratory reference method.
Summary based on the document:
The provided document is a 510(k) clearance letter for a medical device (blood glucose test strips). It attests to the device's "substantial equivalence" to a legally marketed predicate device. This implies that the device demonstrated comparable performance to the predicate through studies (not detailed in this letter), likely including accuracy against a reference method, precision, and interference studies. However, the specific acceptance criteria, study methodologies, and performance results are not included in the provided text.
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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
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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)
Page 6 of 176
§ 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.