(151 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring glucose using a hexokinase method on a specific analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the description, performance studies, or key metrics. The focus is on the chemical reaction and the performance characteristics of the assay itself.
No.
The Glucose Hexokinase II in vitro diagnostic procedure measures glucose levels for diagnosis and treatment of conditions, but it does not directly provide therapy or treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the procedure is used "in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device is an in vitro diagnostic procedure that measures glucose in biological samples using a chemical assay and relies on the Bayer ADVIA® 1650 System, which is a hardware analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine..."
The "Device Description" also refers to it as an "in vitro diagnostic procedure".
These statements clearly indicate that the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis.
N/A
Intended Use / Indications for Use
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
Product codes
CFR
Device Description
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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)
Imprecision:
| ADVIA 1650 Glu Hex II | ADVIA 1650 Glucose Hexokinase | ||||
|---|---|---|---|---|---|
| Specimen type | Level | ||||
| (mg/dL) | Total CV(%) | Specimen type | Level | ||
| (mg/dL) | Total CV(%) | ||||
| Serum | 75 | 2.2 | Serum | 77 | 2.4 |
| Serum | 279 | 2.2 | Serum | 279 | 3.3 |
| Urine | 46 | 4.1 | Urine | 42 | 3.5 |
| Urine | 267 | 3.6 | Urine | 285 | 3.6 |
Correlation (Y=ADVIA 1650 Glucose Hexokinase II, X=ADVIA 1650 Glucose Hexokinase):
| Specimen type | Comparison
System (X) | N | Regression Equation | Syx
(mg/dL) | R | Sample Range
(mg/dL) |
|:-----------------------|:-------------------------|:----|:--------------------|:---------------|:-------|:------------------------|
| Serum | ADVIA 1650 | 194 | Y=1.02x-1.84 | 7.49 | 0.998 | 49.3-589.8 |
| Urine | ADVIA 1650 | 99 | Y=0.97x-7.44 | 5.68 | 0.999 | 0.0-690.8 |
| Plasma(y) vs Serum(x)* | ADVIA 1650 2 | 35 | Y=1.001x+0.088 | 5.33 | 0.9997 | 73.2-623.05 |
*spiked samples used
Interfering Substances:
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Glucose
(mg/dL) | Effect
(% change) |
|:-------------------------|:----------------------------------|:-------------------|:---------------------|
| Bilirubin | 29.1 | 81.32 | 1.05 |
| Hemoglobin | 522 | 80.6 | 0.78 |
| Lipids (Intralipid) | 630 | 80.2 | -4.7 |
Analytical Range: Serum/Plasma/Urine: 0 to 700 mg/dL.
Nonclinical testing demonstrates that this device is as safe and effective as the predicate device.
The changes in the assay represent improvements and allow for blanking, with an aliquot of buffer, and hence subtraction of any potential interference effects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose Hexokinase II method for Bayer ADVIA® 1650 System
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: K011963
1. Intended Use
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # | Predicate Device # |
|---|---|---|---|
| ADVIA 1650 Glucose Hexokinase | B01-4129-01 | T03-1291-62 | K991576 |
3. Device / Method
| Product Name | REF | Calibrator Part # |
|---|---|---|
| ADVIA 1650 Glucose Hexokinase II | 04903429 | T03-1291-62 |
Imprecision
| ADVIA 1650 Glu Hex II | ADVIA 1650 Glucose Hexokinase | ||||
|---|---|---|---|---|---|
| Specimen type | Level | ||||
| (mg/dL) | Total CV(%) | Specimen type | Level | ||
| (mg/dL) | Total CV(%) | ||||
| Serum | 75 | 2.2 | Serum | 77 | 2.4 |
| Serum | 279 | 2.2 | Serum | 279 | 3.3 |
| Urine | 46 | 4.1 | Urine | 42 | 3.5 |
| Urine | 267 | 3.6 | Urine | 285 | 3.6 |
Correlation (Y=ADVIA 1650 Glucose Hexokinase II, X=ADVIA 1650 Glucose Hexokinase)
| Specimen type | Comparison
System (X) | N | Regression Equation | Syx
(mg/dL) | R | Sample Range
(mg/dL) |
|------------------------|--------------------------|-----|---------------------|----------------|--------|-------------------------|
| Serum | ADVIA 1650 | 194 | Y=1.02x-1.84 | 7.49 | 0.998 | 49.3-589.8 |
| Urine | ADVIA 1650 | 99 | Y=0.97x-7.44 | 5.68 | 0.999 | 0.0-690.8 |
| Plasma(y) vs Serum(x)* | ADVIA 1650 2 | 35 | Y=1.001x+0.088 | 5.33 | 0.9997 | 73.2-623.05 |
*spiked samples used
Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Glucose
(mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|--------------------|----------------------|
| Bilirubin | 29.1 | 81.32 | 1.05 |
| Hemoglobin | 522 | 80.6 | 0.78 |
| Lipids (Intralipid) | 630 | 80.2 | -4.7 |
Analytical Range
Serum/Plasma/Urine: 0 to 700 mg/dL
Nonclinical testing demonstrates that this device is as safe and effective as the predicate device.
1
| Package Insert Sections | Glucose Hexokinase assay
(predicate device) | Glucose Hexokinase II assay |
|---------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | similar | similar |
| Summary | similar | similar |
| Principle | similar | similar |
| Reagents | Assay buffer in single aliquot for
reaction | Assay buffer in dual aliquots.
Formulation identical; new format
allows for blanking. |
| Storage | similar | similar |
| Stability | 25 days | Similar, actual dating TBD |
| Precautions | similar | similar |
| Indications of
Deterioration | similar | similar |
| Performance
Characteristics | similar | similar |
| Limitations | Blanking was impossible. Assay
potentially susceptible to interferences. | Blanking now possible;
interference effects eliminated |
| Parameters | similar | similar |
Table of Similarities and Differences between Glucose Hexokinase and Glucose Hexokinase II assay:
The changes in the assay represent improvements and allow for blanking, with an aliquot of buffer, and hence subtraction of any potential interference effects.
Kenneth Cole
9/25/01
Date
Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2001
Kenneth T. Edds, Ph.D. Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K011963
Trade/Device Name: Glucose Hexokinase II Assay for the Advia 1650 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: September 25, 2001 Received: September 26, 2001
Dear Dr. Edds:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared is (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to togens and ment 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). and Cosmetic . Its (. 10) and the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a substions, Title 21, Parts 800 to 898. 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 or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and my of substantial equivalence of your device to a legally marketed nouticate 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 1 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, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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: K011963
NOV 2 0 2001
Device Name: Glucose Hexokinase II Assay for the Advia 1650
Indications for Use:
The Glucose Hexokinase II in vitto diagnostic procedure is intended to measure glucose in human serum, The Chaose Irences. In the Bayer Advia 1650 system. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
Thomas C. O'Brien
Division Sion-Off Division of Clinical Laboratory Devices K 011963 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)