(200 days)
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No
The document describes quality control and calibration materials for a urine oxalate assay, which are standard laboratory reagents and do not involve AI/ML technology. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest the use of such technologies.
No
Explanation: The device is explicitly stated to be "for in vitro diagnostic use only" and used for quality control and calibration of oxalate assays, not for direct treatment or diagnosis of a patient.
No
The provided text describes products (controls and standards) used for quality control and calibration of an oxalate assay, which is a diagnostic method. The products themselves are for "in vitro diagnostic use," meaning they are used in a lab setting to support diagnostics, but they are not diagnostic devices that directly diagnose a condition. They are reagents/materials for the assay.
No
The device is described as controls and standards for an in vitro diagnostic (IVD) assay, which are typically physical reagents and materials, not software. The description mentions use with automated clinical chemistry analyzers and manual operations, further suggesting a hardware/reagent component.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states for both the Oxalate Normal and Elevated Controls and the Oxalate Standard: "It is for in vitro diagnostic use only."
- Intended Use: The intended use describes the products as being used for quality control and calibration of a method for the quantitative determination of urine oxalate. This is a diagnostic process performed in vitro (outside the body) on a biological sample (urine).
- Care Setting: The intended user/care setting is described as "automated clinical chemistry analysers and for manual operations," which are typical environments for performing in vitro diagnostic tests.
Therefore, the device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
Product codes
JIT, JJW
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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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Electron Corporation c/o Ms. Melita Lambiris Quality Assurance Manager 189-199 Browns Road Noble Park, Victoria, 3174 Australia
MAR 1 6 2007
Re: K062521
Trade/Device Name: Oxalate Urine Controls (Normal & Elevated) Oxalate Standard Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJW Dated: March 01, 2007 Received: March 05, 2007
Dear Ms. Lambiris:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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Image /page/2/Picture/1 description: The image shows the logo for Thermo Electron Corporation. The word "Thermo" is in large, bold, black letters. Below it, in smaller black letters, is the phrase "ELECTRON CORPORATION".
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Oxalate Urine Controls (Normal and Elevated) Oxalate Standard
Indications For Use:
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
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 IF NEEDED)
Carol Benson
Division Sign-Off
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Office of In Vitro Diagnostic Device
Evaluation and Safety
062521