(80 days)
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No
The description focuses on a chemical assay method and spectrophotometric detection, with no mention of AI/ML terms or concepts.
No
The device is a diagnostic tool used to measure glucose levels, which aids in the diagnosis and treatment of conditions, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device description details a chemical assay method for measuring glucose, which involves reagents and spectrophotometric detection, indicating a hardware component is necessary for the measurement process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the device is "intended to measure glucose quantitatively in blood and other body fluids." It also mentions that these measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders." This directly aligns with the definition of an IVD, which is a device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a chemical assay that analyzes human serum, plasma, urine, or cerebrospinal fluid. This involves testing specimens in vitro (outside the body).
- Performance Studies: The performance studies describe testing the device's ability to accurately measure glucose in human samples (serum, urine, CSF) and comparing its results to other established methods. This is typical for the validation of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K953847; Glucose/HK assay on the Hitachi 917 Analyzer) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF).
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.
Product codes (comma separated list FDA assigned to the subject device)
CFR
Device Description
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET and ARCHITECT c8000 Systems. The Glucose assay method comparison yielded acceptable correlation with the Glucose/HK assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9995, slope of 1.09, and Y-intercept of - 5.50 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 1.35 mg/dL for the urine application, and a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 4.29 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 1.06, and Y-intercept of - 4.54 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.04, and Y-intercept of -- 2.67 mg/dL for the urine application, and a correlation coefficient of 0.9997, slope of 1.04, and Y-intercept of -3.89 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope of 0.97 and Y-intercept of 0.85 mg/dL for the serum application, a correlation coefficient of 0.9999, slope of 0.96, and Y-intercept of -1.36 mg/dL for the urine application, and a correlation coefficient of 0.9998. slope of 0.95, and Y-intercept of 0.22 mg/dL for the CSF application when compared to the AEROSET System. The Glucose assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Glucose assay. On the AEROSET System, the total %CV for Level 1 is 1.06%, and Level 2 is 1.41% for the serum application, the total %CV for Level 1 is 1.66%, and Level 2 is 1.35% for the urine application, and the total %CV for Level 1 is 1.55%, and Level 2 is 1.69% for the CSF application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 2.15%, and Level 2 is 1.51% for the serum application, the total %CV for Level 1 is 1.01%, and Level 2 is 0.80% for the urine application, and the total %CV for Level 1 is 1.07%, and Level 2 is 1.17% for the CSF application.
The Glucose assay is linear from 5 to 800 mg/dL for the serum/plasma application. The Glucose assay is linear from 1 to 800 mg/dL for the urine/CSF application. The limit of quantitation (sensitivity) of the Glucose assay is 5.0 mg/dL for the serum application, and 1.0 mg/dL for the urine/CSF applications.
These data demonstrate that the performance of the Glucose assay is substantially equivalent to the performance of the Glucose/HK assay on the Hitachi 917 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of quantitation (sensitivity) of the Glucose assay is 5.0 mg/dL for the serum application, and 1.0 mg/dL for the urine/CSF applications.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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510(k) Summary
MAY - 5 2006
Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038
Contact Person Linda Morris Senior Regulatory Specialist MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479
| Date of Preparation of this Summary: | February 13, 2006 |
|---|---|
| Device Trade or Proprietary Name: | Glucose |
| Device Common/Usual Name or | |
| Classification Name: | Glucose |
| Classification Number/Class: | CFR/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K060383
Test Description:
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
Glucose - Conc. 510(k) April 19, 2006
1
Substantial Equivalence:
The Glucose assay is substantially equivalent to the Glucose/HK assay (K953847) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro enzymatic chemical reaction assays.
- . Both assays can be used for the quantitative analysis of glucose.
- . Both assays yield similar results.
- . Both assays are based on the hexokinase/G-6-PDH methodology.
Differences:
None
Intended Use:
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF).
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Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® and ARCHITECT® c8000 Systems. The Glucose assay method comparison yielded acceptable correlation with the Glucose/HK assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9995, slope of 1.09, and Y-intercept of - 5.50 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 1.35 mg/dL for the urine application, and a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 4.29 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 1.06, and Y-intercept of - 4.54 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.04, and Y-intercept of -- 2.67 mg/dL for the urine application, and a correlation coefficient of 0.9997, slope of 1.04, and Y-intercept of -3.89 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope of 0.97 and Y-intercept of 0.85 mg/dL for the serum application, a correlation coefficient of 0.9999, slope of 0.96, and Y-intercept of -1.36 mg/dL for the urine application, and a correlation coefficient of 0.9998. slope of 0.95, and Y-intercept of 0.22 mg/dL for the CSF application when compared to the AEROSET System. The Glucose assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Glucose assay. On the AEROSET System, the total %CV for Level 1 is 1.06%, and Level 2 is 1.41% for the serum application, the total %CV for Level 1 is 1.66%, and Level 2 is 1.35% for the urine application, and the total %CV for Level 1 is 1.55%, and Level 2 is 1.69% for the CSF application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 2.15%, and Level 2 is 1.51% for the serum application, the total %CV for Level 1 is 1.01%, and Level 2 is 0.80% for the urine application, and the total %CV for Level 1 is 1.07%, and Level 2 is 1.17% for the CSF application.
Glucose - Conc. 510(k) April 19, 2006
3
The Glucose assay is linear from 5 to 800 mg/dL for the serum/plasma application. The Glucose assay is linear from 1 to 800 mg/dL for the urine/CSF application. The limit of quantitation (sensitivity) of the Glucose assay is 5.0 mg/dL for the serum application, and 1.0 mg/dL for the urine/CSF applications.
These data demonstrate that the performance of the Glucose assay is substantially equivalent to the performance of the Glucose/HK assay on the Hitachi 917 Analyzer.
Conclusion:
The Glucose assay is substantially equivalent to the Glucose/HK assay on the Hitachi 917 Analyzer as demonstrated by results obtained in the studies.
Glucose - Conc. 510(k) April 19, 2006
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1921 Hurd Drive Irving, TX 75038
MAY - 5 2006
Re: K060383 Trade/Device Name: Glucose test system Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: February 13, 2006 Received: February 22, 2006
Dear Ms. Morris:
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 introduce commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmounts, 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 (DMA), 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 misbandly no 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 additions 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 not he 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 protice 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 (240) 276-0484. 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 tolli the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G. A.
Alberto Gutierrez, Ph.D. 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
K060353 510(k) Number (if known):
Device Name: Glucose
Indications For Use:
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.
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 In Vitro Diagnostics Devices (OIVD) | |
|---|---|
| Division Sign-Off | Page 1 of ______ |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | K060383 |