(35 days)
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No
The summary describes a standard clinical chemistry assay based on enzymatic reactions and spectrophotometry, with no mention of AI or ML.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of uric acid, which aids in diagnosis and treatment, but does not directly provide therapy.
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." This indicates that the device aids in the diagnostic process.
No
The device is an in vitro diagnostic assay, which is a chemical reagent kit used with a specific analyzer (ALCYON 300/300i). This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states in the "Device Description" section: "Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine."
Furthermore, the "Intended Use / Indications for Use" section describes how the assay is used to measure uric acid in biological samples (serum, plasma, urine) for the purpose of diagnosis and treatment of various medical conditions. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
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 on the ALCYON 300/300i Analyzer.
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 (comma separated list FDA assigned to the subject device)
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 yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.
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)
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Uric Acid assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9918, slope = 0.981 and the Y-intercept = 0.599 mg/dL. For the urine application, the correlation coefficient = 0.9854, slope = 0.951 and the Y-intercept = 0.435 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 111 is 2.8% and Level 2/Panel 112 is 2.3%. For the urine application, the total %CV for Level 1/Panel 131 is 4.4% and Level 2/Panel 132 is 3.2%. The Uric Acid assay is linear up to 26 mg/dL. The limit of quantitation (sensitivity) of the Uric Acid assay is 0.3 mg/dL. These data demonstrate that the performance of the Uric Acid assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For the serum application, the correlation coefficient = 0.9918, slope = 0.981 and the Y-intercept = 0.599 mg/dL. For the urine application, the correlation coefficient = 0.9854, slope = 0.951 and the Y-intercept = 0.435 mg/dL.
For the serum application, the total %CV for Level 1/Panel 111 is 2.8% and Level 2/Panel 112 is 2.3%. For the urine application, the total %CV for Level 1/Panel 131 is 4.4% and Level 2/Panel 132 is 3.2%.
The Uric Acid assay is linear up to 26 mg/dL. The limit of quantitation (sensitivity) of the Uric Acid assay is 0.3 mg/dL.
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
§ 862.1775 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.
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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) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | March 31, 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 yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.
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Substantial Equivalence:
The Uric Acid assay is substantially equivalent to the following devices:
- Roche® Cobas Mira® Plus Automated Chemistry Uric Acid assay (K922762) for . the serum application
- Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer . for the urine application
These assays yield similar Performance Characteristics.
Similarities to Roche:
- 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 to Roche:
-
There is a minor difference between the assay ranges. .
Similarities to Boehringer Mannheim: -
Both assays are in vitro clinical chemistry methods. .
-
. Both assays can be used for the quantitative determination of uric acid.
-
. Both assays yield similar clinical results.
Differences to Boehringer Mannheim:
- . 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 on the ALCYON 300/300i Analyzer.
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Uric Acid assay method comparison yielded acceptable correlation with the Roche
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Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9918, slope = 0.981 and the Y-intercept = 0.599 mg/dL. For the urine application, the correlation coefficient = 0.9854, slope = 0.951 and the Y-intercept = 0.435 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 111 is 2.8% and Level 2/Panel 112 is 2.3%. For the urine application, the total %CV for Level 1/Panel 131 is 4.4% and Level 2/Panel 132 is 3.2%. The Uric Acid assay is linear up to 26 mg/dL. The limit of quantitation (sensitivity) of the Uric Acid assay is 0.3 mg/dL. These data demonstrate that the performance of the Uric Acid assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for the urine application.
Conclusion:
The Uric Acid assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Uric Acid assay for the serum application and the Boehringer Mannheim Uric Acid assay on the Hitachi 717Analyzer for the urine application as demonstrated by results obtained in the studies.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 MAY
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038
K981189 Re : Uric Acid Requlatory Class: I Product Code: CDO March 31, 1998 Dated: Received: April 2, 1998
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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 regulations.
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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
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510(k) Number (if known):
Device Name:
Indications For Use:
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. 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 k 981189
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ﮯ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Uric Acid 510(k) April 29, 1998 Uric AcidE2.lvp
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