(81 days)
No
The description focuses on automation of standard laboratory processes and data management, with no mention of AI or ML technologies.
No
The device aids in diagnosis and monitoring therapy, but it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument's test results "aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy."
No
The device description clearly states it is a "fully automatic clinical instrument" that performs physical actions like sample handling and reagent delivery, indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy." This clearly indicates that the device is used to examine specimens derived from the human body (plasma) to provide information for diagnostic purposes.
- Device Description: The description details how the instrument processes samples and reagents to perform analyses on plasma samples, which is a core function of an IVD.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The STA-R Evolution® Expert Series Hemostasis System fits this definition perfectly.
N/A
Intended Use / Indications for Use
The STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Product codes
JPA
Device Description
The STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.
Description of the modification: The modification of the device involves replacement of components for reliability or obsolescence reasons, changes in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability and bug corrections. Additionally, to increase reliability of results, a new option (Reverse Sequence Drilling Mode referred to as PTB) is proposed when using capped tubes (involves software revision and mechanical changes). The modifications consist in new hardware and mechanical components to increase the operation reliability or to replace obsolete components. The software was updated to include operator/user use enhancements, modification of the data post-processing to increase results reliability, and bug corrections. Additionally, to increase results reliability, a new option of Reverse Sequence Drilling Mode {referred to as PTB) (applicable when the plasma volume used in tests on the analyzers is less than 12ul) is implemented when using capped tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Validation Studies (including all the changes mentioned above) were performed. Nevertheless, there are no new questions regarding the Safety, Effectiveness, Technology, Principles of Operation and Performance as evidenced by Risk Assessment and Validation Studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the word "Stago" in a serif font. Above the word is a symbol that looks like a water droplet or a stylized letter. The symbol is positioned directly above the "t" in "Stago", creating a visual element that draws attention to the brand name.
Attachment - 6
Image /page/0/Picture/2 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. Above the word "CONFIDENTIAL" is a handwritten number, "5 093001". The number is written in black ink. The image appears to be a document with a confidentiality classification.
DEC 1 8 2009
510 (k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Umberto V. Parrotta Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054
Phone: (973) 631-1200, x-2044 Facsimile: (973) 695-0095
Contact Person: Umberto V. Parrotta
Data Prepared: September 25, 2009
Name of Modified Device and Name/Address of Sponsor:
STA-R Evolution® Expert Series Hemostasis System or STA-R Evolution® Expert Series.
Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054
Common or Usual Name:
- IVD Coagulation Device/Instrument. .
- Automated and Semi-Automated Hematology Device. .
- Multi-Parametric Analyzer .
Classification Name:
System, Multipurpose for In Vitro Coagulation Studies
Predicate Device:
Diagnostica Stago's STA-R Evolution® Expert Series Automated Multi-Parametric Analyzer (K082675).
Purpose of the Special 510(k) Notice:
The STA-R Evolution® Expert Series Hemostasis System is a modification to the company's own legally marketed device, STA-R Evolution® Expert Series (K082675).
The modification of the device involves replacement of components for reliability or obsolescence reasons, changes in the device application software to provide
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Image /page/1/Picture/1 description: The image shows the word "Stago" in a serif font, with the first letter capitalized. Above the word, there is a stylized graphic that resembles a water droplet or a stylized letter "T". The graphic is filled with a textured pattern, giving it a distinct visual element above the brand name.
Attachment - 6
operator/user use enhancements and modification of the data post-processing to increase results reliability and bug corrections. Additionally, to increase reliability of results, a new option (Reverse Sequence Drilling Mode referred to as PTB) is proposed when using capped tubes (involves software revision and mechanical changes).
Indication/Intended Use:
The STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Principles of Operation:
The STA-R Evolution® Expert Series Hemostasis System is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization.
The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.
STA-R Evolution® Expert Series Hemostasis System is the modified version of the Company's STA-R Evolution® Expert Series (K082675), legally marketed predicate device. The modification of the device involves replacement of components for reliability or obsolescence reasons, changes in the device application software to provide operator/user use enhancements, modification of the data post-processing to increase results reliability and bug corrections. In addition, also to increase results reliability, a new option is proposed when using capped tubes.
Principles of Operation for the aforementioned analyses are the same between the subject submission device and the Predicate Device.
Substantial Equivalence:
STA-R Evolution® Expert Series Hemostasis System and its Predicate Device, STA-R Evolution 9 Expert Series (K082675) have the same Indications for Use, Technology, Principles of Operation and comparable Performances. The technical characteristics have been modified thus, resulting in better performance, without any change in technology or principle of operation.
The modifications consist in new hardware and mechanical components to increase the operation reliability or to replace obsolete components. The software was updated to
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Image /page/2/Picture/1 description: The image shows the word "Stago" in a serif font. Above the word is a small, abstract graphic that appears to be a stylized droplet or crescent shape. The text is clear and legible, and the graphic is simple and recognizable.
Attachment - 6
include operator/user use enhancements, modification of the data post-processing to increase results reliability, and bug corrections. Additionally, to increase results reliability, a new option of Reverse Sequence Drilling Mode {referred to as PTB) (applicable when the plasma volume used in tests on the analyzers is less than 12ul) is implemented when using capped tubes.
Nevertheless, there are no new questions regarding the Safety, Effectiveness, Technology, Principles of Operation and Performance as evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above. Therefore, the STA-R Evolution® Expert Series Hemostasis System is substantially equivalent to the STA-R Evolution® Expert Series (K082675), predicate device.
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Image /page/3/Picture/0 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 underneath it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEC 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Diagnostica Stago, Inc. c/o Umberto V. Parrotta Director of Regulatory Affairs and Quality Assurance 5 Century Drive Parsippany, NJ 07054
Re: K093001
Trade/Device Name: STA-R Evolution® Expert Series Hemostasis System Regulation Number: 21 CFR §864.5425
Regulation Name: System, multipurpose for in vitro coagulation studies
Regulatory Class: Class II Product Code: JPA Dated: December 8, 2009 Received: December 10, 2009
Dear Umberto V. Parrotta:
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 -- Umberto V. Parrotta
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A. Vane in Char
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "Stago" in a serif font. Above the word, there is a stylized graphic that appears to be two curved shapes, one above the other. The shapes are dark and abstract, possibly representing leaves or water droplets. The overall impression is that of a logo for a company or brand named Stago.
Attachment - 2A
DEC 1 8 2009
Indications for Use
K093001 510(k) Number (if known):
Device Name:
STA-R Evolution® Expert Series Hemostasis System
Indications for Use:
STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Prescription Use __ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Senke R. Si
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K09300)
ん
DSI-STA-R-E5-Attachment-02Av1-IndicationsforUseForm