(249 days)
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No
The device description and performance studies detail a standard enzymatic assay for glucose measurement, with no mention of AI, ML, or related technologies.
No.
The device is for in vitro diagnostic use to measure glucose levels, which aids in the diagnosis and treatment of conditions but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF... Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose."
No
The device description clearly outlines a two-component reagent system and mentions absorbance readings, indicating a chemical assay that requires physical reagents and a chemistry analyzer (the ADVIA 1650 Chemistry system) to function. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Sample Type: The device is used to measure glucose in "human serum, plasma, urine and CSF", which are biological samples taken from the body.
- Purpose: The measurements are used "in the diagnosis and treatment of carbohydrate metabolism disorders", which is a diagnostic purpose.
- Device Description: The description details a chemical reaction that occurs in vitro (outside the body) to determine the glucose concentration.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.
Product codes (comma separated list FDA assigned to the subject device)
CFR. Hexokinase, Glucose
Device Description
The ADVIA 1650 Chemistry Glucose Hexokinase 3 (GLUH 3) method uses a twocomponent reagent. Sample is added to Reagent 1, which contains the buffer, ATP, and NAD. Absorbance readings of the sample in Reagent 1 are taken and are used to correct for interfering substances in the sample. Reagent 2 is added, which initiates the conversion of glucose and the development of absorbance at 340/410 nm. The difference between the absorbance in Reagent 1 and Reagent 2 is proportional to the glucose concentration.
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
Not Found
Indicated Patient Age Range
Not Found
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)
The new device (Glucose Hexokinase 3 reagent) and the predicate device (Glucose Hexokinase II reagent) were compared.
Accuracy / Correlation Studies:
Serum: Y = 1.001x + 0.3; N=99 r=1.000 (vs. ADVIA 1650 (ADVIA GLUH reagent)
Plasma (Li-Heparin): Y = 1.001x + 0.2 , N=88; r=1.000
Plasma (K-EDTA) Y = 1.002x - 0.0 , N=87; r=1.000
CSF: Y = 1.005x - 0.1 , N=113; r=1.000
Urine: Y = 0.989x - 0.3 , N=51; r=1.000
Precision (total) Studies:
0.8% at 87 mg/dL (serum)
0.7% at 297 mg/dL (serum)
1.1% at 49 mg/dL (urine)
1.9% at 301 mg/dL (urine)
1.0% at 56 mg/dL (CSF)
0.8% at 97 mg/dL (CSF)
Interfering Substances:
Bilirubin-NSI to 30 mg/dL at glucose level of 54 mg/dL
Hemoglobin-NSI up to 1000 mg/dL at glucose level of 52 mg/dL
Lipemia (Intralipid)-NSI to 1000 mg/dL
Comparative testing of the ADVIA 1650 Chemistry Glucose Hexokinase_3 reagent demonstrates substantially equivalent performance to the ADVIA Chemistry Glucosc Hexokinasc II reagent cleared under K042015.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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
MAR - 7 2011
510(k) Summary of Safety and Effectiveness for the
ADVIA® 1650 Chemistry Glucose Hexokinase 3 (GLUH 3) method
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.
A. 510(k) Number:
B. Date of Preparation: July 26, 2010
C. Proprietary and Established Names:
ADVIA® 1650 Chemistry Glucose Hexokinase 3 (GLUH 3) reagent
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Kira Gordon, Sr. Regulatory Affairs Specialist
Office: (914) 524-2996 Fax: (914) 524-2500
E. Regulatory Information:
ADVIA 1650 Chemistry Glucose Hexokinase 3 Reagent
-
- Regulation section: 21 CFR & 862.1345 Glucose test system.
-
- Classification: Class II
-
- Product Code: CFR. Hexokinase, Glucose
-
- Panel: Clinical Chemistry
F. Predicate Device:
ADVIA 1650 Chemistry Glucose Hexokinase 3 reagent is substantially equivalent to the ADVIA Chemistry Glucose Hexokinase II reagent cleared under K042015
G. Device Description:
The ADVIA 1650 Chemistry Glucose Hexokinase 3 (GLUH 3) method uses a twocomponent reagent. Sample is added to Reagent 1, which contains the buffer, ATP, and NAD. Absorbance readings of the sample in Reagent 1 are taken and are used to correct for interfering substances in the sample. Reagent 2 is added, which initiates the conversion of glucose and the development of absorbance at 340/410 nm. The difference between the absorbance in Reagent 1 and Reagent 2 is proportional to the glucose concentration.
1
H. Intended Use:
For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose
I. Substantial Equivalence Information:
The new device (Glucose Hexokinase 3 reagent) and the predicate device (Glucose Hexokinase II reagent) were compared. A comparison of the important features between the new device and the predicate device is provided in the following table:
| Item | Device | Predicate |
|---|---|---|
| Analyte | Glucose | Same |
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of glucose in | ||
| human serum, plasma, urine and CSF on | ||
| the ADVIA 1650 Chemistry system. | ||
| Such measurements are used in the | ||
| diagnosis and treatment of carbohydrate | ||
| metabolism disorders including diabetes | ||
| mellitus, neonatal hypoglycemia, | ||
| idiopathic hypoglycemia, and insulin | ||
| overdose | Same | |
| Sample type | human serum, plasma, urine and CSF | |
| (plasma - Li Heparin and K EDTA) | human serum, plasma, urine and CSF | |
| (plasma – Li Heparin) | ||
| Instrument to | ||
| be used | ADVIA 1650 Chemistry | ADVIA 1650 Chemistry |
| Method | ||
| Principle | based on the method by Slein using | |
| hexokinase and glucose-6-phosphate | ||
| dehydrogenase enzymes. | Same | |
| Calibrators | Siemens Healthcare Diagnostics | |
| Chemistry Calibrator REF 09784096 | Same | |
| Reportable | ||
| range | 4 -700 mg/dL | 0 -700 mg/dL |
| Traceability | Standard reference material 965a from | |
| NIST | Same | |
| Format | Liquid | Concentrate |
| Reagents | Two: R1 and R2 | Three: R1, R2 and R2 mix |
| Interfering | ||
| Substances * | Bilirubin-NSI to 30 mg/dL at glucose | |
| level of 54 mg/dL | ||
| Hemoglobin-NSI up to 1000 mg/dL at | ||
| glucose level of 52 mg/dL | ||
| Lipemia (Intralipid)-NSI to 1000 mg/dL | Bilirubin-NSI to 25 mg/dL at glucose | |
| level of 80 mg/dL | ||
| Hemoglobin-NSI up to 500 mg/dL at | ||
| glucose level of 80 mg/dL | ||
| Lipemia (Intralipid)-NSI to 500 mg/dL | ||
| at glucose level of 80 mg/dL | ||
| Precision | ||
| (total) | 0.8% at 87 mg/dL (serum) | |
| 0.7% at 297 mg/dL (serum) | ||
| 1.1% at 49 mg/dL (urine) | ||
| 1.9% at 301 mg/dL (urine) | ||
| 1.0% at 56 mg/dL (CSF) | ||
| 0.8% at 97 mg/dL (CSF) | 2.2% at 74.7 mg/dL (serum) | |
| 2.0% at 247.6 mg/dL (serum) | ||
| 4.1% at 45.8 mg/dL (urine) | ||
| 3.6% at 266.7 mg/dL (urine) | ||
| 3.1% at 36.9 mg/dL (CSF) | ||
| 2.7% at 60.2 mg/dL (CSF) | ||
| Accuracy / | ||
| Correlation | Serum: | |
| $Y = 1.001x + 0.3$ ; N=99 r=1.000 (vs. | ||
| ADVIA 1650 (ADVIA GLUH reagent) |
Plasma (Li-Heparin):
$Y = 1.001x + 0.2$ , N=88; r=1.000
Plasma (K-EDTA)
$Y = 1.002x - 0.0$ , N=87; r=1.000
CSF:
$Y = 1.005x - 0.1$ , N=113; r=1.000
Urine:
$Y = 0.989x - 0.3$ , N=51; r=1.000 | Serum:
$Y = 1.02x - 1.84$ ; N=194 r=0.998 (vs.
ADVIA 1650 (ADVIA glucose-single
reagent formulation))
Plasma (Li Heparin):
$Y = 1.00x - 0.09$ , N=35; r=1.000
CSF:
$Y = 1.03x - 1.25$ , N=55; r=0.987
Urine:
$Y = 0.97x - 7.44$ , N=99; r=0.999 |
2
- NSI = No Significant Interference. A percentage effect > 10% is considered significant interference.
J. Conclusion:
Comparative testing of the ADVIA 1650 Chemistry Glucose Hexokinase_3 reagent demonstrates substantially equivalent performance to the ADVIA Chemistry Glucosc Hexokinasc II reagent cleared under K042015.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
HAR 0 7 2011
Siemens Healthcare Diagnostics, Inc. c/o Kira Gordon Senior Regulatory Affairs Specialist 511 Benedict Avenue. Tarrytown, NY. 10591. USA
Re: K101854
Trade/Device Name: ADVIA Chemistry Glucose Hexokinase (GLUH_3) Reagent Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CFR Dated: February 23, 2011 Received: February 24, 2011
Dear Ms. Gordon
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, 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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Indication for Use
KIDI854 510(k) Number (if known):
Device Name:
ADVIA® Chemistry GLUH_3 Reagent
Indication For Use:
For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.
Prescription Use V _ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benett
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101854