(63 days)
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No
The summary describes a standard in vitro diagnostic assay based on enzymatic reactions, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic device used to measure glucose, 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 the device is "an in vitro diagnostic device" and that its measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders."
No
The device is an in vitro diagnostic device that measures glucose in biological fluids using a chemical reaction (hexokinase and glucose-6-phosphate dehydrogenase). This involves physical reagents and a system (ADVIA IMS® System) to perform the assay, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.
The Bayer ADVIA IMS® Glucose method is for in vitro diagnostic device for use to measure glucose in human serum, plasma (lithium heparin), urine and cerebrospinal fluid (CSF) on the ADVIA IMS® system. Such measurements are used as an aid in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.
Product codes (comma separated list FDA assigned to the subject device)
CFR
Device Description
The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.
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)
CSF Imprecision:
ADVIA IMS Glucose
Level (mg/dL): 36, Within-run CV (%): 2.1, Total CV (%): 2.3
Level (mg/dL): 60, Within-run CV (%): 2.1, Total CV (%): 2.2
CSF Correlation (X=ADVIA 1650, Y=ADVIA IMS):
N: 64, Regression Equation: Y = 0.92x + 2.3, Syx: 1.9, r: 0.997, Sample Range mg/dL: 31-132
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.
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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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OCT 1 1 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose methods for ADVIA® IMSTM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K052/63
1. Intended Use
The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.
2. Assay Principle
The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.
3. Predicate Device
| Product Name | Reagent Ref # | Calibrator Ref # |
|---|---|---|
| Bayer ADVIA® 1650 | ||
| Glucose Hexokinase II | 04903429 | 09784096 |
Device / Method 4.
| Product Name | Reagent Ref # | Calibrator Ref # |
|---|---|---|
| Bayer ADVIA IMS® | ||
| Glucose | 08594722 | 09784096 |
5. CSF Imprecision
| ADVIA IMS Glucose | ADVIA 1650 Glucose Hexokinase II | ||||
|---|---|---|---|---|---|
| Level | |||||
| (mg/dL) | Within-run | ||||
| CV (%) | Total | ||||
| CV (%) | Level | ||||
| (mg/dL) | Within-run | ||||
| CV(%) | Total | ||||
| CV (%) | |||||
| 36 | 2.1 | 2.3 | 31 | 1.6 | 2.7 |
| 60 | 2.1 | 2.2 | 59 | 1.8 | 3.1 |
6. CSF Correlation (X=ADVIA 1650, Y=ADVIA IMS)
| N | Regression
Equation | Syx | r | Sample Range
mg/dL |
|----|------------------------|-----|-------|-----------------------|
| 64 | Y = 0.92x + 2.3 | 1.9 | 0.997 | 31-132 |
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7. Interfering Substances
Interfering substances are not expected in cerebrospinal fluid samples.
8. Analytical Range
1 mg/dL - 600 mg/dL
.
9. Minimum Detectable Concentration
l mg/dL
10/05/2005__________________________________________________________________________________________________________________________________________________________________ Date
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Tel: 914-524-3494
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
OCT 1 1 2005
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 10591-5097
Re: K052163
Trade/Device Name: Glucose assay for the ADVIA IMS® System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: August 31, 2005 Received: September 1, 2005
Dear Mr. Holle
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) it wasternent date of the Medical Device Amendments, or to commerce pror to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, de rices that have been receised require approval of a premarket approval application (PMA). and Costicule 71ct (71ct) that the neview, subject to the general controls provisions of the Act. The Tou may, alerefore, mainer of the Act include requirements for annual registration, listing of general controls profitions 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 be subject to subir dadnotial controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Thie 21, becaments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advisod that I Dris issuation that your device complies with other requirements of the Act that I Dri has Indus a deted regulations administered by other Federal agencies. You must or any it cacal statutes and regalaments, including, but not limited to: registration and listing (21 comply with an the Prec 11 CFR Parts 801 and 809); and good manufacturing practice 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 I ou may 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting 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
510(k) Number (if known):_K0521 63
Device Name: Glucose assay for the ADVIA IMS® System
Indications For Use:
The Bayer ADVIA IMS® Glucose method is for in vitro diagnostic device for use to measure glucose in human serum, plasma (lithium heparin), urine and cerebrospinal fluid (CSF) on the ADVIA IMS® system. Such measurements are used as an aid in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.
Prescription Use _X (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052163
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