(204 days)
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No
The provided text describes a standard automated clinical chemistry analyzer with features like automated maintenance monitoring and data backup. There is no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technologies in medical devices.
No
The device is a clinical chemistry analyzer used for in vitro diagnostic purposes to measure various clinical assays for disease diagnosis or health assessment, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used in the diagnosis of disease or other conditions".
No
The device description explicitly states it is a "fully automated clinical chemistry analyzer" with "replaceable parts" and a "throughput of up to 230 tests per hour," indicating it is a physical hardware device that performs laboratory tests.
Yes, based on the provided text, the DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The text explicitly states: "The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only."
- Intended Use: The intended use clearly describes the device's purpose in the "diagnosis of disease or other conditions, including a determination of the state of health," which is a core function of IVD devices.
- Measurement of Clinical Assays: The device is intended for the measurement of various clinical assays (Albumin, Alkaline Phosphatase, etc.) in biological samples, which is a typical activity for IVD instruments.
- Routine Diagnostic Clinical Laboratory Use: The intended use and device description specify that it is for "routine diagnostic clinical laboratory use," indicating its role in a clinical setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid.
The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the Counter-Use
Product codes
CFR, CJE, CIX, CIT, CIG, CIC, CGX, CDQ, CEK, CEO, CHH, CDT, CDO, CKA, JJE
Device Description
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data.
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
small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
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
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Key Metrics
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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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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, 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 stylized eagle with three wavy lines representing its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Re:
APR 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bola Nicholson MT (ASCP) Technical Manager Thermo Electron Corporation Clinical Chemistry 331 South 104th Street Louisville, CO 80027
K042767 Trade/Device Name: DataPro™/ DataPro Plus™ Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, CJE, CIX, CIT, CIG, CIC, CGX, CDQ, CEK, CEO, CHH, CDT, CDO,CKA, JJE Dated: March 4, 2005 Received: March 7, 2005
Dear Ms. Nicholson:
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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, 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
2
INDICATIONS FOR USE STATEMENT
510(K) Number K042767
Device Name: DataPro™/DataPro Plus™ Clinical Chemistry Analyzer
Indications for Use:
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid.
The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042767