(148 days)
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No
The summary describes a quantitative determination of salicylate using a chemistry system, which is a standard laboratory assay and does not mention any AI/ML components.
No
The device is described as being for "in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma." This indicates it is a diagnostic device, not a therapeutic one. It helps diagnose a condition (salicylate toxicity) but does not treat it.
Yes
The 'Intended Use / Indications for Use' explicitly states "For in vitro diagnostic use" and "Such measurements are used in the diagnosis of salicylate toxicity and overdose".
No
The device is an in vitro diagnostic (IVD) test for use on a specific chemistry analyzer (ADVIA 1650). IVD tests typically involve reagents and hardware components, not just software. The lack of a device description further supports this, as a software-only device would likely have a description focused on its software functions.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems."
This statement clearly indicates that the device is intended for use outside of the body to diagnose a condition (salicylate toxicity and overdose) by analyzing biological samples (serum and plasma). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose
Product codes
DKJ
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.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3830 Salicylate test system.
(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird-like figure with three stylized wing-like shapes.
Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon Sr. Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
K093939 Re:
Trade Name: Advia Chemistry Salicylate Regulation Number: 21 CFR §862.3830 Regulation Name: Salicylate Test System Regulatory Class: Class II Product Codes: DKJ Dated: May 14, 2010 Received: May 17, 2010
MAY 1 9 2010
Dear Dr. Gordon:
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); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse 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-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
AC
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093939
Device Name: ADVIA® Chemistry Salicylate Reagent
Indications for Use:
For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Bennen
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093939
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