(31 days)
Not Found
No
The device description details a standard clinical chemistry assay based on enzymatic reactions and spectrophotometry. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on standard analytical metrics like correlation, precision, and linearity, not AI/ML-specific metrics.
No
The device is an in vitro diagnostic assay used for the quantitative determination of uric acid, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy or therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders," indicating its role in diagnosis. The "Device Description" also labels it as an "in vitro diagnostic assay."
No
The device description clearly describes a chemical assay that involves reagents and a measurement of absorbance, indicating a hardware component (likely a spectrophotometer or similar device) is required to perform the test. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the assay is "used for the quantitation of uric acid in serum, plasma, or urine" and that these measurements are "used in the diagnosis and treatment of numerous renal and metabolic disorders." This clearly indicates the device is intended for use on samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description states, "Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine." This directly identifies the device as an in vitro diagnostic assay.
- Predicate Device: The document lists a "Predicate Device" which is another IVD assay (Boehringer Mannheim® Uric Acid assay on the Hitachi® 717 Analyzer). This further supports the classification of this device as an IVD.
The core function of the device is to analyze biological samples (serum, plasma, urine) outside of the body ("in vitro") to provide information used for diagnosis and treatment, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine. Measurements of uric acid 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.
Product codes
75CDO
Device Description
Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.
Mentions image processing
Not Found
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
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
Comparative performance studies were conducted using the AEROSET™ System. The Uric Acid assay method comparison yielded acceptable correlation with the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9990, slope = 1.074 and the Y-intercept = 0.134 mg/dL for serum. For the urine application, the correlation coefficient = 0.9973, slope = 0.999, and the Y-intercept = 0.184 mg/dL. Precision studies were conducted using the Uric Acid assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 2.3% and Level 2/Panel 102 is 1.3%. For the urine application, the total %CV for Level 1/Panel 201 is 3.1% and Level 2/Panel 202 is 1.8%. The Uric Acid assay is linear up to 33.1 mg/dL for the serum application and 433.8 mg/dL for urine. The limit of quantitation (sensitivity) of the Uric Acid assay is 0.2 mg/dL. These data demonstrate that the performance of the Uric Acid assay is substantially equivalent to the performance of the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer.
Key Metrics
Correlation coefficient = 0.9990 (serum), 0.9973 (urine)
Slope = 1.074 (serum), 0.999 (urine)
Y-intercept = 0.134 mg/dL (serum), 0.184 mg/dL (urine)
Total %CV for serum: Level 1/Panel 101 is 2.3%, Level 2/Panel 102 is 1.3%
Total %CV for urine: Level 1/Panel 201 is 3.1%, Level 2/Panel 202 is 1.8%
Linearity: up to 33.1 mg/dL (serum), 433.8 mg/dL (urine)
Limit of quantitation (sensitivity): 0.2 mg/dL
Predicate Device(s)
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
AUN 1 9 1998
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 18, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Uric Acid |
| Device Common/Usual Name or Classification Name: | Uric Acid |
| Classification Number/Class: | 75CDO/Class I |
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. The assigned 510(k) number is:
Test Description:
Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.
Uric Acid 510(k) May 18, 1998 Unc Acid twp
Section II Page 1
UNDUM
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Substantial Equivalence:
The Uric Acid assay is substantially equivalent to the Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer for the serum and urine application.
These assays vield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro clinical chemistry methods.
- Both assays can be used for the quantitative determination of uric acid. .
- Both assays vield similar clinical results. .
Differences:
- . There is a minor difference between the assay ranges.
Intended Use:
The Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Uric Acid assay method comparison vielded acceptable correlation with the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9990, slope = 1.074 and the Y-intercept = 0.134 mg/dL for serum. For the urine application, the correlation coefficient = 0.9973, slope = 0.999, and the Y-intercept = 0.184 mg/dL. Precision studies were conducted using the Uric Acid assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 2.3% and Level 2/Panel 102 is 1.3%. For the urine application, the total %CV for Level 1/Panel 201 is 3.1% and Level 2/Panel 202 is 1.8%. The Uric Acid assay is linear up to 33.1 mg/dL for the serum application and 433.8 mg/dL for urine. The
Section II Page 2
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limit of quantitation (sensitivity) of the Uric Acid assay is 0.2 mg/dL. These data demonstrate that the performance of the Uric Acid assay is substantially equivalent to the performance of the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer.
Conclusion:
The Uric Acid assay is substantially equivalent to the Boehringer Mannheim Uric Acid assay on the Hitachi 717Analyzer as demonstrated by results obtained in the studies.
Uric Acid 510(k) May 18, 1998
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Section II Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, composed of three curved lines that suggest the shape of a bird in flight. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
This I g 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive 75038 Irvinq, Texas
K981766 Re: Uric Acid Requlatory Class: I Product Code: CDO Dated: May 18, 1998 May 19, 1998 Received:
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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
5
510(k) Number (if known):
Device Name: Uric Acid
Indications For Use:
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. Measurements of uric acid 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.
(Division Sign-Off)
Division of Clinical, Laboratory Devices
510(k) Number K981766
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
00000000
Uric Acid 510(k) May 18, 1998 Uric Acid Iwp