(53 days)
Not Found
Not Found
No
The summary describes an in vitro diagnostic device for measuring uric acid, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic (IVD) for determining uric acid levels, which aids in diagnosis and treatment, but it does not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Uric Acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders," indicating its role in identifying or characterizing a disease or condition.
No
The device is an In Vitro Diagnostic (IVD) for measuring uric acid in human serum. This typically involves reagents and hardware components (automated chemistry analyzers) to perform the test, not just software. The summary does not describe any software component as the primary or sole medical device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers." The phrase "In Vitro" is the key indicator that this device is used to test samples taken from the body, rather than being used directly on or in the body.
- Sample Type: The device is intended to measure uric acid in "human serum," which is a biological sample taken from a patient.
- Purpose: The measurements are used in the "diagnosis and treatment of numerous renal and metabolic disorders," which is a typical application for IVD devices.
The other sections being "Not Found" or "Not Applicable (In Vitro Diagnostic)" further support the conclusion that this is an IVD device, as these sections are often more relevant to imaging or AI-based medical devices.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.
Uric Acid measurements 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)
JHB
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)
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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.
Not Found
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)
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved lines, possibly representing a stylized human figure or a symbol of health and well-being.
AUG 2 1 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N. W. 58th Street Miami, Florida 33166
510(k) Number: K012038 Re: Trade/Device Name: Uric Acid Reagent Regulation Number: 862.1775 Regulatory Class: Class I, Reserved Product Code: JHB Dated: June 14, 2001 Received: June 29, 2001
Dear Mr. Johnston:
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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotton will and it you ding of substantial equivalence of your device to a legally marketed nothroution. - 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 If you desire specific acres vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 594-4566. 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 miorination on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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Page __ 1__ of __ 1___________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.
Uric Acid measurements 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander San Juan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012038
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)