(35 days)
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No
The summary describes a standard clinical chemistry assay based on enzymatic reactions and spectrophotometric detection. There is no mention of AI or ML in the device description, intended use, or any other section.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of glucose, which aids in diagnosis and treatment, but it does not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders." This indicates the device's role in diagnosing medical conditions.
No
The device description clearly indicates it is an in vitro diagnostic assay that utilizes chemical reactions and spectrophotometric detection on a specific analyzer (ALCYON 300/300i). This involves physical reagents and hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is used for the "quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF)" and that these measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders." This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the biochemical process used to measure glucose in biological samples (serum, plasma, urine, CSF). This is a hallmark of an in vitro diagnostic test.
- Explicit Statement: The "Device Description" section begins with the statement: "Glucose is an in vitro diagnostic assay..."
These points definitively classify this device as an In Vitro Diagnostic.
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) on the ALCYON 300/300i Analyzer. 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
CFR
Device Description
Glucose is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The Glucose assay is a clinical chemistry assay in which 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-PD) 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 NADI-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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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.
0
CONFIDENTIAL
MAY 7 1998
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | March 31, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Glu |
| Device Common/Usual Name or Classification Name: | Glucose |
| Classification Number/Class: | 75CFR/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:
Test Description:
Glucose is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The Glucose assay is a clinical chemistry assay in which 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-PD) 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 NADI-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.
Section II Page I
1
Substantial Equivalence:
The Glucose assay is substantially equivalent to the following devices:
- Roche® Cobas Mira® Plus Automated Chemistry System Glucose assay (K953847) . for the serum application
- Boehringer Mannheim® Glucose/HK assay on the Hitachi® 717 Analyzer . (K812303) for the urine and CSF applications
These assays yield similar Performance Characteristics.
Similarities to Roche:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of glucose. .
- Both assays yield similar clinical results. .
Differences to Roche:
-
There is a minor difference between the assay range. .
Similarities to Boehringer Mannheim: -
Both assays are in vitro clinical chemistry methods. .
-
Both assays can be used for the quantitative determination of glucose. .
-
. Both assays yield similar clinical results.
Differences to Boehringer Mannheim:
- · There is a minor difference between the assay range.
Intended Use:
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer.
2
DEPARTMENT OF
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 MAY
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas
Re : K981185 Glucose Requlatory Class: II Product Code: CFR March 31, 1998 Dated: Received: April 2, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 leqally 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer. 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k 181185
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)