(241 days)
Not Found
No
The description focuses on a chemical assay using enzymatic reactions and spectrophotometry. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an in vitro diagnostic assay used to measure uric acid levels, which aids in diagnosis and treatment monitoring, but it does not directly administer therapy or produce a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section states that the device is used to measure uric acid and these measurements "are used in the diagnosis and treatment of numerous renal and metabolic disorders." This directly indicates its diagnostic purpose.
No
The device description clearly describes a chemical assay (in vitro diagnostic) performed on a physical instrument (ARCHITECT c8000 System) using reagents. This involves hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to measure uric acid in serum, plasma, and urine." It also mentions that the measurements are "used in the diagnosis and treatment of numerous renal and metabolic disorders." This clearly indicates that the device is used to analyze samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" and describes the chemical reactions used to measure uric acid in human samples.
- Predicate Device: The mention of a "Predicate Device" with a K number (K981766) is typical for regulatory submissions for IVD devices.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Architect Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine.
The ARCHITECT 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.
Product codes (comma separated list FDA assigned to the subject device)
KNK
Device Description
The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.
The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
Uric acid + O2 + 2H2O ->(Uricase) Allantoin + CO2 + H2O2
H2O2 + 4-AAP + HMMPS ->(POD) Quinoelineine Dye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Uric Acid assay is substantially equivalent to the Abbott On-Market Uric Acid assay. Both assays yield similar performance characteristics as demonstrated in the non-clinical performance data in this 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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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Next Generation Uric Acid (K102568) Response Attachment H – 510(k) Summary
Architect Uric Acid 510(k) Summary (Summary of Safety and Effectiveness)
MAY – 6 2011
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Name:
Linda Morris, Sr. Regulatory Specialist Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 2471 1921 Hurd Drive Irving, TX 75038
Device Name:
Reagents:
Classification Name: Acid, Uric, Uricase (U.V.) Trade Name: Architect Uric Acid Common Name: Uric Acid Governing Regulation: 862.1775 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: KNK
Legally marketed device to which equivalency is claimed:
Abbott Uric Acid Assay (K981766)
Intended Use of Device:
The Architect Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or urine.
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Next Generation Uric Acid (K102568) Response Attachment H – 510(k) Summary
Description of Device:
The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.
The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
$$\begin{aligned} \text{Uric acid} + \text{O}_2 + 2\text{H}_2\text{O} &\xrightarrow{\text{Uricase}} \text{Allantoin} + \text{CO}_2 + \text{H}_2\text{O}_2\ \text{H}_2\text{O}_2 + 4\text{-}\text{AAP} + \text{HMMPS} &\xrightarrow{\text{POD}} \text{Quinoelineine Dye} \end{aligned}$$
Comparison of Technological Characteristics:
The Uric Acid assay uses a uricase methodology for the quantitative determination of uric acid in human serum, plasma, or urine. The Abbott On-Market Uric Acid assay also uses a uricase methodology for the quantitative measurement of uric acid in human serum, plasma, or urine.
Summary of Non-Clinical Performance:
The Uric Acid assay is substantially equivalent to the Abbott On-Market Uric Acid assay. Both assays yield similar performance characteristics as demonstrated in the non-clinical performance data in this 510(k) submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
HAY 6 2011
Abbott Laboratories Diagnostics Division c/o Linda K. Morris Sr. Regulatory Specialist 1921 Hurd Drive Irving,TX 75038-4313
Re: K102568 Trade Name: ARCHITECT Uric Acid Assay Regulation Number: CFR 862.1775 Regulation Name: Uric acid test system Regulatory Class: Class II Product Codes: KNK Dated: April 26, 2011 Received: April 27, 2011
Dear Ms. Morris:
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 levice is substantally equivalent (for the in interstate commerce problems 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 greneral 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of pavense events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: አንያ ነ
Enclosure
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Next Generation Uric Acid (K102568) Response Attachment G - Indications for Use Form
Uric Acid Indication(s) for Use Form
K102568 510(k) Number (if known):
Device Name: ARCHITECT Uric Acid
Indication(s) for Use:
The ARCHITECT 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.
Prescription Use × (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)
ARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102568