(76 days)
No
The description focuses on automation of standard laboratory processes and data management, with no mention of AI or ML algorithms for analysis or interpretation. The modifications are described as component replacements and software enhancements for user experience and reliability, not for advanced analytical capabilities.
No
The device is described as a clinical instrument designed to perform tests on human plasmas to aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's results "aid in the diagnosis of coagulation abnormalities." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a physical instrument with automated sample handling, reagent delivery, analysis, and reporting, controlled by a central processing unit. While it includes software for control and data management, it is fundamentally a hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section 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 device processes samples and reagents to perform analyses, which is characteristic of an in vitro diagnostic instrument.
- Use of Reagents: The mention of using "Diagnostica Stago reagents in addition to open adaptation of other currently available reagents" further supports its role in performing chemical or biological tests on samples.
The core function of analyzing human plasma to aid in diagnosis and therapy monitoring aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA Compact® Automated Multi-Parametric Analyzer 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 Compact® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument. 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.
The STA Compact® is a modified version of the company’s own legally marketed device, STA Compact® (K961579). The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability. The software modification essentially consists of addition of a quality improvement function which provides Hook Effect Detection when the vWF (Von Willebrand factor) test is performed on the sample plasma. This function identifies the hook effect (showing abnormally low results for high concentrations of the vWF factor) which subsequently allows the instrument to perform appropriate re-dilutions to obtain reliable results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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)
As evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above), no new questions were raised regarding the Safety, Effectiveness, Performance, Indications for Use, Technology and the Principles of Operation.
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.
0
CONFIDENTIAL
Image /page/0/Picture/1 description: The image shows the word "Stago" in a serif font. Above the word is a logo consisting of two abstract shapes, one resembling a leaf and the other a crescent moon. The logo is positioned directly above the "t" in "Stago", creating a visual connection between the text and the symbol.
Attachment - 6
DEC 2 2 2 2009
510 (k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Umberto V. Parrotta, Jr. 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, Jr.
Date Prepared: October 05, 2009.
Name of Modified Device and Name/Address of Sponsor:
STA Compact® Automated Multi-Parametric Analyzer or STA Compact®.
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 Compact® Automated Multi-Parametric Analyzer (K961579).
Purpose of the Special 510(k) Notice:
The STA Compact® is a modification to the company's own legally marketed device, STA Compact® (K961579).
The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability. The software modification essentially consists of
1
Image /page/1/Picture/1 description: The image shows the word "Stago" in a serif font. Above the word is a logo consisting of two curved shapes, one above the other, that resemble stylized water droplets or crescent moons. The logo is positioned directly above the "t" in "Stago", creating a visual connection between the symbol and the text.
Attachment - 6
addition of a quality improvement function which provides Hook Effect Detection when the vWF (Von Willebrand factor) test is performed on the sample plasma.
Indication/Intended Use:
The STA Compact® Automated Multi-Parametric Analyzer 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 Compact Automated Multi-Parametric Analyzer 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.
The STA Compact® is the modified version of the Company's STA Compact® (K961579), legally marketed Predicate Device. The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability.
Principles of Operation for the aforementioned analyses are the same between the subject submission device and the Predicate Device.
Substantial Equivalence:
The STA Compact® and its Predicate Device, STA Compact® (K961579) have the same Indications for Use, Technology, Principles of Operation and comparable Performances. The previously mentioned characteristics have been slightly modified to improve performance, without changing the principle of operation or the technological characteristics. The modifications consist of new hardware and mechanical components to increase the operation reliability or to replace obsolete components. The software is also updated to include operator/user use enhancements and modification of the data post-processing is done to increase results reliability. The software modification, subject of this Special 510(k) essentially consists of addition of a function, Hook Effect Detection when the vWF test is performed on the sample
2
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Attachment - 6
plasma. This function is operational during vWF (Von Willebrand factor) testing. This function identifies the hook effect (showing abnormally low results for high concentrations of the vWF factor) which subsequently allows the instrument to perform appropriate re-dilutions to obtain reliable results.
As evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above), no new questions were raised regarding the Safety, Effectiveness, Performance, Indications for Use, Technology and the Principles of Operation. Therefore, the STA Compact® is Substantially Equivalent to the STA Compact® Predicate Device.
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DEC 2 2 2 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, New Jersey 07054
Re: K093167
Trade/Device Name: STA Compact® Automated Multi-Parametric Analyzer Regulation Number: 21 CFR 864.7290 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: December 4, 2009 Received: December 8, 2009
Dear Mr. 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 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 class II (Special Controls), 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
4
Page 2 - Mr. Parrotta
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). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
ia m chan
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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Attachment - 2A
Indications for Use
510(k) Number (if known): K093167
Device Name: STA Compact® Automated Multi-Parametric Analyzer
Indications for Use:
The STA Compact® Automated Multi-Parametric Analyzer 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)
Serik R. S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K09316 7
DSI-STA-CompactB6-Attachment-02Av1-IndicationsforUseStatementForm.doc