(126 days)
Not Found
No
The description focuses on automated sample handling, reagent delivery, analysis based on chronometric and photometric methods, and standard statistical analysis of results. There is no mention of AI or ML techniques.
No.
The device is an analyzer that performs tests to aid in the diagnosis of coagulation abnormalities or to monitor anticoagulant therapy, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's results "aid in the diagnosis of coagulation abnormalities."
No
The device description clearly states it is a "fully automatic bench-top system" and describes hardware components like sample handling, reagent delivery, and analysis mechanisms, indicating it is a physical instrument, not software only.
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 "indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy." This clearly describes a diagnostic purpose performed on a biological sample (human plasma) outside of the body.
- Device Description: The description details how the instrument analyzes "human plasmas" using various test methodologies (clotting time and photometric assays) to produce results. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The performance studies involve analyzing "Test samples" (presumably human plasma based on the intended use) and comparing the results to a predicate device, further supporting its role in diagnostic testing.
The core function of the device is to perform tests on biological samples in vitro (outside the living body) to provide information for diagnosis or monitoring, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of 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 Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top 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, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device.
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. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparison of the device and predicate device performance characteristics was conducted during the performance validation study. Validation of the STA -Satellite® with the STA-R® predicate device was performed at an internal site and two external sites.
Test samples were analyzed in duplicate on the STA -Satellite and the STA-R. Results were analyzed by standard statistical methods (mean, standard deviation, 95% confidence intervals, correlation between instruments and comparison to acceptance criteria).
Correlation data between the STA -Satellite and the STA-R were within the acceptance criteria for all assays and all sites. There was no significant difference or clinically significant difference between the results from the instruments between the sites and instruments.
Key Metrics
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, with the first letter capitalized and the rest in lowercase. Above the word, there is a stylized logo consisting of three curved shapes arranged in a circular fashion. The logo is black, and the word "Stago" is also black.
Attachment - 6
510(k) SUMMARY
DEC 1 2 2008
Diagnost
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
Date Prepared: August 06, 2008
Name of Modified Device and Name/Address of Sponsor:
STA Satellite®
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 Devices:
- Diagnostica Stago SAS' STA-R® Automated Multi-Parametric Analyzer . (K983460).
- Sigma Diagnostic Inc.'s AMAX Destiny Coagulation Analyzer (K021162). .
File: DSI-Satellite-Attachment-06v4-510(k)Summary.doc
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Image /page/1/Picture/0 description: The image shows the word "Stago" in a serif font, with the first letter capitalized. Above the word is a logo consisting of three curved shapes arranged in a circular pattern. The logo is black, and the word "Stago" is also black.
CONFIDENTIAL
Attachment - 6
510(k) SUMMARY
Predicate Device Manufacturer:
Diagnostica Stago SAS
Purpose of the Special 510(k) notice:
The STA Satellite® is a modification to the company's own legally marketed device, STA-R®.
Indication/Intended Use:
The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Technological Characteristics:
The STA Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top 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, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device.
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. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred
2
Image /page/2/Picture/0 description: The image shows the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is a stylized graphic element that appears to be composed of three curved shapes arranged in a circular or triangular pattern. The graphic is solid black, contrasting with the white background.
CONFIDENTIAL
Attachment - 6
510(k) SUMMARY
to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.
Performance Data:
Comparison of the device and predicate device performance characteristics was conducted during the performance validation study. Validation of the STA -Satellite® with the STA-R® predicate device was performed at an internal site and two external sites.
Test samples were analyzed in duplicate on the STA -Satellite and the STA-R. Results were analyzed by standard statistical methods (mean, standard deviation, 95% confidence intervals, correlation between instruments and comparison to acceptance criteria).
Correlation data between the STA -Satellite and the STA-R were within the acceptance criteria for all assays and all sites (see Table below for assays performed). There was no significant difference or clinically significant difference between the results from the instruments between the sites and instruments.
In addition, the STA Satellite® is CE Marked and has been in commerce in France since September 2004. There have been no adverse performance-related events or analogous complaints resulting in recalls with regards to its design during this time that would raise questions of safety and effectiveness.
In conclusion, performance validation study comparison results between the STA Satellite® and the STA-R device instrument and predicate device indicate statistically similar results. , Analysis of which demonstrates substantial equivalence.
Substantial Equivalence:
The STA Satellite® has the same intended use and similar indications, principles of operation, and technological characteristics as the STA-R® and the AMAX predicate devices. The differences in the external architecture, software, and chronometric viscosity detection do not raise any new questions of safety or effectiveness. Performance data and risk assessment demonstrate that the STA Satellite® is as safe and effective as STA-R@the predicate devices. Thus, the STA Satellite® is substantially equivalent to its predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diagnostica Stago, Inc. C/o Umberto V. Parrotta Five Century Drive Parsippany, New Jersey 07054
DEC 1 2 2008
Re: K082248
Trade/Device Name: STA Satellite® Automated Multi-Parametric Analyzer Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: October 03, 2008 Received: October 06, 2008
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. Isting 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 (OS) 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
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Page 2 - Mr. Parrotta
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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marian Chan, PhD
Acting Division 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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CONFIDENTIAL Attachment - 2A
Indications for Use Form
510(k) Number (if known): KO822248
Device Name:
Satellite™ Automated Multi-Parametric Analyzer
Indications for Use:
The Satellite™ is a fully automatic clinical instrument designed for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device
Office of In Vitro Diamostic Device Evaluation and Safely
Prescription Use (Per 21 C.F.R. 801.109)
510(k) OR K082246 Over-The-Counter Use
(Optional Format 1-2-96)
File: DSI-Satellite-Attachment-2A-IndicationsForUseStatementForm.doc