(64 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic assay for glucose measurement and does not mention any AI or ML components.
No
The device is an in vitro diagnostic device used for quantitative determination of glucose, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assays are "in vitro diagnostic device[s] for use in the quantitative determination of glucose" and that "Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders."
No
The device is described as an in vitro diagnostic device for use on the ADVIA® 1650 Chemistry system, which is a hardware system. The summary describes performance characteristics of the assay itself, not a standalone software product.
Yes, the provided text explicitly states that the Bayer ADVIA® 1650 Glucose Hexokinase II assay and the Bayer ADVIA® 1650 Glucose Oxidase assay are in vitro diagnostic devices.
The "Intended Use / Indications for Use" section clearly defines them as such and describes their use in the quantitative determination of glucose in human biological samples (CSF, serum, plasma, and urine) for the diagnosis and treatment of carbohydrate metabolism disorders. This aligns perfectly with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer ADVIA 1650 Glucose Oxidase and Glucose Hexokinase II assays are in vitro diagnostic devices for use in the quantitative determination of glucose levels in human cerebrospinal fluid (CSF), serum, plasma, and urine on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypogleemia, idiopathic hypoglycemia and insulin overdose.
Product codes
CGA, CFR
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
Not Found
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)
Imprecision
ADVIA 1650 Glucose Oxidase
- Level (mg/dL): 58.0, Within-run CV(%): 1
- Level (mg/dL): 34.2, Within-run CV(%): 1.1
ADVIA 1650 Glucose Hexokinase II
- Level (mg/dL): 60.2, Within-run CV(%): 1.2
- Level (mg/dL): 36.9, Within-run CV(%): 1.7
Roche Glucose Hexokinase
- Level (mg/dL): 31, Within-run CV(%): 1.6
- Level (mg/dL): 59, Within-run CV(%): 1.8
Correlation (Y=ADVIA 1650, X=comparison system)
- Glucose (Oxidase)
- Comparison System (x): Roche (On Integra)
- N: 56
- Regression Equation: Y = 0.97x + 4.47
- Syx: 7.6
- r: 0.994
- Sample Range mg/dL: 37-530
- Glucose (Hexokinase)
- Comparison System (x): Roche (On Integra)
- N: 55
- Regression Equation: Y = 1.03x - 1.25
- Syx: 6.4
- r: 0.987
- Sample Range mg/dL: 39-214
Interfering Substances
Interfering substances are not expected in cerebrospinal fluid samples.
Analytical Range
- Glu-HKII: 0- 700 mg/dL
- Glu-Ox: 0- 750 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Roche Glucose Hexokinase
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
SEP 2 9 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose methods for ADVIA® 1650TM
This summary of 510(k) safety and effectiveness information is being submitted in accordance This summary of 910(th) sales) and 1 and 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K642015
1. Intended Use
The Bayer ADVIA 1650 Glucose Oxidase and Glucose Hexokinase II assays are in vitro The Dayer AD TIA 1000 Of to occasion in the sure glucose levels in human cerebrospinal fluid (CSF), serum, plasma, and urine on the ADVIA® 1650 Chemistry System. Such measurements (CDF), seruin, phalma, and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypogleemia, idiopathic hypoglycemia and insulin overdose.
2. Predicate Device
| Product Name | Reagent
Part # | Calibrator Part # |
|--------------------------|-------------------|-------------------|
| Roche Glucose Hexokinase | 20763020 | 10759350 |
Device / Method 3.
| Product Name | Reagent
Part #/ BAN # | Calibrator Part
#/ BAN # |
|-----------------------------------------|--------------------------|-----------------------------|
| Bayer ADVIA® 1650
Glucose Hexokinase | B01-4597-01/
04005536 | T03-1291-62/
09784096 |
| Bayer ADVIA® 1650
Glucose Oxidase | B01-4130-01/
04903429 | T03-1291-62/
09784096 |
Imprecision
| ADVIA 1650 Glucose
Oxidase | | ADVIA 1650 Glucose
Hexokinase II | | Roche Glucose Hexokinase | |
|-------------------------------|---------------------|-------------------------------------|---------------------|--------------------------|---------------------|
| Level
(mg/dL) | Within-run
CV(%) | Level
(mg/dL) | Within-run
CV(%) | Level
(mg/dL) | Within-run
CV(%) |
| 58.0 | 1 | 60.2 | 1.2 | 31 | 1.6 |
| 34.2 | 1.1 | 36.9 | 1.7 | 59 | 1.8 |
1
| Specimen
Type | Comparison
System (x) | N | Regression
Equation | Syx | r | Sample Range
mg/dL |
|-------------------------|--------------------------|----|------------------------|-----|-------|-----------------------|
| Glucose
(Oxidase) | Roche
(On Integra) | 56 | $Y = 0.97x + 4.47$ | 7.6 | 0.994 | 37-530 |
| Glucose
(Hexokinase) | Roche
(On Integra) | 55 | $Y = 1.03x - 1.25$ | 6.4 | 0.987 | 39-214 |
Correlation (Y=ADVIA 1650, X=comparison system)
Interfering Substances
Interfering substances are not expected in cerebrospinal fluid samples.
Analytical Range
Glu-HKII: 0- 700 mg/dL Glu-Ox: 0- 750 mg/dL
Carter
7/20/04
Date
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
SEP 2 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer Healthcare LLC. Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
K042015 Re:
R042019
Trade/Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System Glucose Oxidase assay for the ADVIA® 1650 Chemistry System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CFR Dated: July 15, 2004 Received: August 5, 2004
Dear Mr. Holle:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowe 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 1 ou may, diereleve, marrer of the Act include requirements for annual registration, listing of general controls proficiouring 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 it may or subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oo louits in there announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devised alat termination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I odoral statutes and regirements, including, but not limited to: registration and listing (21
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and will your to be finding of substantial equivalence of your device to a legally premaince noticate 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, r fou don't on the promotion and advertising of your device, please contact the Office of of quebelle on the preside Evaluation and Safety at (301) 594-3084. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KOL 2015
Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System
Indications For Use:
The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device The Bayer ADVAN® TUSO Glaoooo Hoxokhabo in human cerebrospinal fluid (CSF), for use in the first for use in the quantitutive actornination on the ADVIA® 1650 Chemistry system. serum, plasma (illinian nopalin), the diagnosis and treatment of carbohydrate Such measurements are about the claghester the clayments, idiopathic hypoglycemia and insulin overdose.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert Cert
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and
510(k) K042015
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Glucose Oxidase assay for the ADVIA® 1650 Chemistry System
Indications For Use:
The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use The Bayer ADVIA® 7000 Glucose in human cerebrospinal fluid (CSF), serum,
in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, in the quantitative determination of groups in haman seems . Such measurements are
plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are plasma and urne on the ADVIA® 1000 Onehabelism disorders including
used in the diagnosis and treatment of carbohydrate and insulin used in the diagnosis and treathent of Sarbonyards in the months and insulin overdose.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto Lutz
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042015