DIATRON PICTUS 400

K101741 · Diatron Group · CGA · Jan 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101741
• Device Name: DIATRON PICTUS 400
• Applicant: Diatron Group
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Pictus 400 is an automated clinical chemistry analyzer for laboratory use. It processes serum samples to measure electrolytes (Na, K, Cl) and glucose, plus other analytes depending on reagent compatibility. Operates in clinical laboratory settings by trained technicians. Device automates sample handling and photometric/ion-selective electrode analysis to provide quantitative analyte concentrations. Results are displayed for healthcare providers to assist in diagnosing and monitoring metabolic and electrolyte disorders. Benefits include high-throughput, standardized testing for clinical decision-making.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing clinical chemistry analyzers.

Technological Characteristics

Automated clinical chemistry analyzer. Utilizes photometric and ion-selective electrode (ISE) sensing principles for analyte detection. Designed for serum sample analysis. System is a standalone laboratory instrument.

Indications for Use

Indicated for clinical laboratory use to measure Na, K, Cl, and Glucose in serum, and other adaptable analytes. Used for monitoring electrolyte imbalances, diagnosing diseases related to potassium levels, detecting/treating metabolic disorders, and diagnosing/treating carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

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).

{1}------------------------------------------------

Page 2

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 [phone]. 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 [phone]. 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 [phone] 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

{2}------------------------------------------------

## 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