(154 days)
Not Found
No
The description focuses on the chemical and biological components of the test kit and the analytical method (immuno-turbidimetric). There is no mention of AI, ML, or related concepts.
No.
The device is an in vitro diagnostic (IVD) test kit used for the antigenic assay of free Protein S in plasma, which provides diagnostic information rather than therapeutic treatment.
Yes
The device aids in the antigenic assay of free Protein S in plasma, which is a diagnostic measurement.
No
The device is a test kit containing physical reagents (latex microparticles, buffer) for an in vitro diagnostic assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "antigenic assay of free Protein S in plasma by the immuno-turbidimetric method." This is a laboratory test performed on a biological sample (plasma) to provide information about a specific substance (free Protein S) within that sample.
- Device Description: The description details a "test kit" containing reagents (latex microparticles, buffer) used to perform this assay on "citrated human plasma." This further confirms its use in a laboratory setting for analyzing a human biological sample.
- Method: The "immuno-turbidimetric method" is a common technique used in in vitro diagnostics to measure the concentration of substances in biological fluids.
- Predicate Device: The mention of a "predicate device" with a K number (K010963) indicates that this device is being compared to a previously cleared medical device, which in this context, is almost certainly another IVD.
All these points strongly indicate that the STA® - Liatest® Free PS kits are designed and intended for use in a laboratory setting to perform diagnostic testing on human plasma, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.
Product codes
GGP
Device Description
The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two lines of text. The first line appears to be a handwritten word, possibly a name or identifier, but it is difficult to decipher due to the handwriting style. The second line is the word "CONFIDENTIAL" in a bold, sans-serif font, indicating that the document or information is sensitive and not for public disclosure.
Image /page/0/Picture/1 description: The image shows the word "Stago" in a stylized font, with a logo above the word. The logo appears to be a stylized droplet or leaf shape. Below the word "Stago" is the date "DEC 22 2009" in a smaller, less stylized font. The text and date are slightly blurred, suggesting the image may be a scan or a photograph of a document.
Attachment - 5
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
Date Prepared: July 17, 2009
Name of Device and Name/Address of Sponsor:
STA® - Liatest® Free PS
Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054
Common or Usual Name:
- Free Protein S IVD Device. .
- IVD Factor Deficiency Test.
Classification Name:
- Factor Deficiency Test. t
Predicate Device:
- STA® Liatest® Free Protein S (K010963). .
Purpose of the Special 510(k) Notice:
- STA® Liatest® Free PS is a modification of the Company's previously FDA . cleared device, STA® - Liatest® Free Protein S. Specifically, the currently marketed product (predicate device) is pre-calibrated, whereas the calibration for the modified device (the subject of this submission) is performed with a set of calibrator plasmas (Diagnostica Stago's STA® - Free PS Calibrator)
File: DSI-STA-LiatestFreeProteinS-Attachment-05v2-510(k)Summary.doc
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Image /page/1/Picture/0 description: The image shows the word "Stago" in a serif font. Above the word is a logo that appears to be a stylized leaf or droplet shape. The logo is black and white, with the word "Stago" in a lighter color, possibly white or light gray.
CONFIDENTIAL
Attachment - 5
510(k) SUMMARY
Indication/Intended Use:
The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.
Technological Characteristics:
The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).
Substantial Equivalence:
The STA® - Liatest® Free PS and the predicate device, STA® - Liatest® Free Protein S (K010963) are identical products regarding indication/intended use, formulation or materials of construction, technology, and safety. The primary difference between the subject product and predicate device is the use of an external calibrator for the subject product of this submission versus precalibration for the predicate device. This difference is accounted in the procedure section of the package insert. Based upon the aforementioned comparisons and those designated in the SE Comparison Chart, the product, STA® - Liatest Free PS and the predicate device, STA - Liatest - Free Protein S are similar in indication/intended use, technology, principles of operation, and application of use (with IVD medical devices) thus yielding no new questions in safety. effectiveness, or technology. Therefore, this concludes the product STA Liatest Free PS is substantially equivalent to the predicate device, STA® -Liatest® Free Protein S (K010963).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line style.
DEC 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: K092170
Trade/Device Name: STA® Liatest® Free PS Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: November 25, 2009 Received: November 27, 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
3
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/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/cdrh/industry/support/index.html.
Sincerely yours,
ia m chor
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/4/Picture/0 description: The image shows the word "Stago" in a serif font, with the "S" capitalized and larger than the rest of the letters. Above the word is a stylized graphic that resembles a crescent shape with a teardrop shape below it. The teardrop shape has a speckled texture, creating a visual element above the text.
CONFIDENTIAL
Attachment - 1
Indications for Use
510(k) Number (if known):
Device Name: STA®- Liatest® Free PS.
Indication for Use:
The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.
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 (OIVD) (
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092170
File: DSI-STA-LiatestFreeProteinS-Attachment-01-IndicationsForUseStatementForm.doc Page 1 of l