(217 days)
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No
The summary describes a standard clinical chemistry analyzer for measuring basic electrolytes and glucose, with no mention of AI/ML, image processing, or data analysis beyond standard quantitative measurements.
No.
The device is an autoanalyzer used for in vitro diagnostic measurements of various analytes in serum, not for direct treatment or therapy of a patient.
Yes
The device is described as measuring analytes like Na, K, Cl, and Glucose for the "diagnosis" and "treatment" of various diseases and disorders (e.g., electrolyte imbalances, metabolic disorders, diabetes mellitus), which directly aligns with the definition of a diagnostic device.
No
The device description is not found, but the intended use clearly describes a clinical laboratory autoanalyzer designed for direct determination of analytes in serum. This strongly implies a physical hardware device, not software alone.
Yes, based on the provided information, the Autoanalyzer Pictus 400 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "Clinical Laboratory Use" and involves the "direct determination of Na, K, Cl in serum, and Glucose in serum, and to measure a variety of analytes... depending on the reagent used." This involves testing biological samples (serum) outside of the body to provide information for diagnosis and treatment.
- Specific Analytes: The device measures specific analytes (Na, K, Cl, Glucose) that are used for diagnostic purposes (monitoring electrolyte imbalances, diagnosing diseases with high/low potassium, detecting/treating metabolic disorders, diagnosing/treating carbohydrate metabolism disorders).
- Care Setting: It's intended for "Clinical Laboratory Use," which is a typical setting for IVD devices.
The definition of an IVD device generally includes instruments, reagents, and systems intended for use 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. The Autoanalyzer Pictus 400 fits this description.
N/A
Intended Use / Indications for Use
Autoanalyzer Pictus 400 is designed for Clinical Laboratory Use, with direct determination of Na, K, Cl in serum, and Glucose in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. 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."
Product codes
CGA, CEM, CGZ, JGS, JJE
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
Not Found
Intended User / Care Setting
Clinical Laboratory Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized representation of a bird or eagle, with its wings forming a human profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Diatron Group c/o Jim Schepp 2545 Montclaire Circle, Westo. FL 33327
Re: K101741
Trade/Device Name: Diatron PICTUS 400 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: CGA, CEM. CGZ, JGS, JJE Dated: January 6, 2011 Received: January 7, 2011
JAN 2 5 2011
Dear: Mr. Schepp:
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,
CA
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 Form
510(k) Number (if known): K101741 Device Name: Pictus 400
Indications for Use:
Autoanalyzer Pictus 400 is designed for Clinical Laboratory Use, with direct determination of Na, K, Cl in serum, and Glucose in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. 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."
Prescription Use X (21CFR 801 Subpart C) (Part 21CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101741