(264 days)
K/DEN not listed but implied as the predicate in the table
ADVIA 1650
No
The summary describes a standard in vitro diagnostic assay for measuring uric acid levels, with performance data based on analytical methods and comparisons to predicate devices. There is no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is an in vitro diagnostic device used to measure uric acid, which aids in diagnosis and treatment, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device" and is "used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders."
No
The device is an in vitro diagnostic device that measures uric acid in biological samples, indicating it relies on physical components and chemical reactions, not solely software.
Yes, the provided text explicitly states that the Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device.
The "Intended Use / Indications for Use" section clearly defines its purpose: "The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine."
N/A
Intended Use / Indications for Use
The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
Product codes
KNK
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
The performance studies include:
A. Imprecision (serum):
ADVIA IMS:
Level (mg/dL) 3.7, Total CV (%) 2.3
Level (mg/dL) 7.7, Total CV (%) 1.6
Level (mg/dL) 9.9, Total CV (%) 1.1
Advia 1650:
Level (mg/dL) 3.9, Total CV (%) 1.9
Level (mg/dL) 8.6, Total CV (%) 1.6
Level (mg/dL) 10.0, Total CV (%) 2.3
Imprecision (urine):
ADVIA IMS:
Level (mg/dL) 20.2, Total CV (%) 5.2
Level (mg/dL) 28.9, Total CV (%) 3.6
Level (mg/dL) 38.4, Total CV (%) 2.6
Advia 1650:
Level (mg/dL) 12.4, Total CV (%) 2.3
Level (mg/dL) 23.9, Total CV (%) 5.2
B. Correlation (Y=ADVIA IMS, X=Comparison system):
Specimen type: Serum; Comparison System (X): CDC Uricase; N: 117; Regression Equation: Y=0.98X+0.11; Syx (mg/dL): 0.27; R: 0.999; Sample Range (mg/dL): 1.5-26.2
Specimen type: Serum; Comparison System (X): Advia 1650; N: 100; Regression Equation: Y=0.96X+0.29; Syx (mg/dL): 0.37; R: 0.998; Sample Range (mg/dL): 1.5-23.6
Specimen type: Plasma (y), Serum (x); Comparison System (X): Advia 1650; N: 54; Regression Equation: Y=1.01X-0.05; Syx (mg/dL): 0.08; R: 0.998; Sample Range (mg/dL): 2.8-7.3
Specimen type: Urine; Comparison System (X): CDC Uricase; N: 10; Regression Equation: Y=1.035X-0.37; Syx (mg/dL): 1.11; R: 0.999; Sample Range (mg/dL): 3.8-182.8
Specimen type: Urine; Comparison System (X): Advia 1650; N: 63; Regression Equation: Y=0.96X-1.08; Syx (mg/dL): 2.70; R: 0.998; Sample Range (mg/dL): 5.7-198.7
C. Interfering Substances:
Interfering: Bilirubin (unconjugated); Interfering Sub. Conc. (mg/dL): 30; Uric Acid Conc. (mg/dL): 7.6; Effect (% change): -5
Interfering: Bilirubin (conjugated); Interfering Sub. Conc. (mg/dL): 30; Uric Acid Conc. (mg/dL): 7.6; Effect (% change): -6
Interfering: Hemoglobin; Interfering Sub. Conc. (mg/dL): 750; Uric Acid Conc. (mg/dL): 7.5; Effect (% change): -7
Interfering: Lipids (Intralipid); Interfering Sub. Conc. (mg/dL): 1000; Uric Acid Conc. (mg/dL): 7.0; Effect (% change): -1
Interfering: Acetaminophen; Interfering Sub. Conc. (mg/dL): 280 µg/mL; Uric Acid Conc. (mg/dL): 20.9; Effect (% change): -5
Interfering: Ascorbic Acid; Interfering Sub. Conc. (mg/dL): 200; Uric Acid Conc. (mg/dL): 21.1; Effect (% change): -5
Interfering: Salicylate; Interfering Sub. Conc. (mg/dL): 500; Uric Acid Conc. (mg/dL): 21.3; Effect (% change): -5
Analytical Range (serum): 0-26 mg/dL
Analytical Range (urine): 0-230 mg/dL
Key Metrics
Not Found
Predicate Device(s)
ADVIA 1650 Uric Acid (K/DEN not listed but implied as the predicate in the table)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, 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 1 8 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid Method for ADVIA IMS
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: HOA2096 (leave blank)
1. Intended Use
The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| ADVIA 1650 Uric Acid | B01-4131-01 | T03-1291-62 |
3. Device / Method
| Product Name | Reagent BAN # | Calibrator BAN # |
|---|---|---|
| ADVIA IMS Uric Acid | 07383256 | 06798711 |
A. Imprecision (serum)
| ADVIA IMS | Advia 1650 | ||
|---|---|---|---|
| Level | |||
| (mg/dL) | Total | ||
| CV (%) | Level | ||
| (mg/dL) | Total | ||
| CV(%) | |||
| 3.7 | 2.3 | 3.9 | 1.9 |
| 7.7 | 1.6 | 8.6 | 1.6 |
| 9.9 | 1.1 | 10.0 | 2.3 |
1
Imprecision (urine)
| ADVIA IMS | Advia 1650 | ||
|---|---|---|---|
| Level (mg/dL) | Total CV (%) | Level (mg/dL) | Total CV (%) |
| 20.2 | 5.2 | 12.4 | 2.3 |
| 28.9 | 3.6 | 23.9 | 5.2 |
| 38.4 | 2.6 |
B. Correlation (Y=ADVIA IMS, X=Comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
|---|---|---|---|---|---|---|
| Serum | CDC Uricase | 117 | Y=0.98X+0.11 | 0.27 | 0.999 | 1.5-26.2 |
| Serum | Advia 1650 | 100 | Y=0.96X+0.29 | 0.37 | 0.998 | 1.5-23.6 |
| Plasma (y), Serum (x) | Advia 1650 | 54 | Y=1.01X-0.05 | 0.08 | 0.998 | 2.8-7.3 |
| Urine | CDC Uricase | 10 | Y=1.035X-0.37 | 1.11 | 0.999 | 3.8-182.8 |
| Urine | Advia 1650 | 63 | Y=0.96X-1.08 | 2.70 | 0.998 | 5.7-198.7 |
C. Interfering Substances
| Interfering | Interfering Sub.
Conc. (mg/dL) | Uric Acid
Conc. (mg/dL) | Effect
(% change) |
|-----------------------------|-----------------------------------|----------------------------|----------------------|
| Bilirubin
(unconjugated) | 30 | 7.6 | -5 |
| Bilirubin
(conjugated) | 30 | 7.6 | -6 |
| Hemoglobin | 750 | 7.5 | -7 |
| Lipids (Intralipid) | 1000 | 7.0 | -1 |
| Acetaminophen | 280 µg/mL | 20.9 | -5 |
| Ascorbic Acid | 200 | 21.1 | -5 |
| Salicylate | 500 | 21.3 | -5 |
Analytical Range (serum): 0-26 mg/dL
Analytical Range (urine): 0-230 mg/dL
Laure S. Adli
Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue, Tarrytown, NY 10591.
6/21/02
Date
Date
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K022096
Trade/Device Name: Uric Acid Assay for the ADVIA Integrated Modular System (IMS) Regulation Number: 21 CFR § 862.1775 Regulation Name: Uric acid test system Regulatory Class: I Product Code: KNK Dated: January 17, 2003 Received: January 21, 2003
MAR 1 8 2003
Dear Dr. Edds:
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.
3
Page 2 -
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 (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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Koa 2-096 510(k) Number:
Device Name: Uric Acid Assay for the ADVIA IMS
Indications for Use:
The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
(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)
Carl Simon for Jean Cooper, DUM
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022096