(29 days)
No
The summary describes a standard clinical analyzer with mechanical and optical components and software, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No.
The device is an in vitro diagnostic (IVD) device used to perform tests on human plasmas to aid in diagnosis or monitor therapy, not to directly treat a condition.
Yes
The device description explicitly states that the results "aid in the diagnosis of coagulation abnormalities." This indicates its role in identifying or characterizing a disease or condition, which is the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components (cuvette, metal ball, needles, detection systems, light source, sensor) in addition to software.
Yes, based on the provided information, the STA Compact Max® is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device performs tests on human plasmas and the results aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. This aligns perfectly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a clinical laboratory analyzer designed to perform tests on human plasma.
- Anatomical Site: The anatomical site is listed as "In vitro testing of human plasma," further confirming its use outside of the living body.
Therefore, the STA Compact Max® fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA Compact Max® is a fully automatic clinical analyzer 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 (comma separated list FDA assigned to the subject device)
JPA
Device Description
Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.
The device consists of the following components:
- 1 a cuvette, which holds the patient sample and any needed reagent;
- -2a metal ball located in the cuvette, that is induced to oscillate to measure coagulation;
- -3three needles that will aspirate and dispense the patient's sample and reagents into the cuvette;
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
-5a light source and sensor to transmit light through the cuvette containing the sample and reagents that subsequently measures the light absorbed as a reaction takes place; - Software which conducts the measurement and test determination; -6-
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
In vitro testing of human plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Laboratory or other Health Care Laboratory.
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)
The STA Compact Max and its Predicate Device, STA Compact® (K093167), have the same Intended Use/Indications for Use, same fundamental technological characteristics, principles of operation and comparable performances characteristics. The modifications consist in a new PC on-board computer, with new operating system, new peripherals, a new graphical user interface to include operator/user use enhancements and to improve easy to use.
As evidenced by Risk Assessment and Validation Studies, no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation. Therefore, The STA Compact Max® is substantially equivalent to the STA Compact® Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment_10
510(k) Summary
STA Compact Max®
FEB 1 2 2013
| A. | 510(k) Submitter information | 1 |
|---|---|---|
| B. | Device Information | 2 |
| C. | Predicate Device Information | 2 |
| D. | Indication/Intended Use | 3 |
| E. | Purpose of the Special 510(k) Notice | 3 |
| F. | Description of the device | 3 |
| 1) Principles of Operation | 4 | |
| 2) Fundamental technologies | 4 | |
| G. | Substantial Equivalence | 5 |
A. 510(k) Submitter information
| Submitter's name | Diagnostica STAGO Inc. |
|---|---|
| Address | 5 Century Drive |
| Parsippany, New Jersey 07054 | |
| Phone Number | 973.631.1200 |
| Fax Number | 973.867.6030 |
| Date of Preparation | 01/11/2013 |
Application Correspondent and Contact Person information
| Name | Carlo d'Alessandro
Director, IVD Quality and Regulatory
Donawa Lifescience Consulting |
|--------------|---------------------------------------------------------------------------------------------|
| Address | Piazza Albania, 10 - 00153 Rome, Italy |
| Phone Number | +39 06 578 2665 |
| Fax Number | +39 06 574 3786 |
1
B. Device Information
| Device Trade Name | STA Compact Max®. |
|---|---|
| Device Common Name | IVD Coagulation Device/Instrument |
| Automated and Semi-Automated Hematology device | |
| Multi-Parametric Analyzer | |
| Device Classification Name | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class | Class II |
| Panel | Part 864 - Hematology and Pathology Devices |
| Product Code | JPA |
| Regulation Number | 864.5425 |
Image /page/1/Picture/5 description: The image shows the text "Picture 1: STA Compact Max®". The text is written in a serif font and is left-aligned. The word "Picture" is underlined. The "®" symbol is a registered trademark symbol.
Image /page/1/Picture/6 description: The image shows a large piece of medical machinery. The machine is white and gray, and it has a large opening in the front. The inside of the machine is dark, and there are some objects visible inside. The machine appears to be a CT scanner or MRI machine.
C. Predicate Device Information
| 510(k) Number | K093167 |
|---|---|
| Device Trade Name | STA Compact®.Automated Multi-Parametric Analyzer |
| Device Common Name | STA Compact® |
| IVD Coagulation Device/Instrument | |
| Automated and Semi-Automated Hematology device | |
| Multi-Parametric Analyzer | |
| Device Classification Name | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class | Class II |
| Panel | Part 864 - Hematology and Pathology Devices |
| Product Code | JPA |
| Regulation Number | 864.5425 |
Image /page/1/Picture/12 description: The image shows the text "Picture 2: STA Compact® (K093167)". The text is written in a serif font and is left-aligned. The words "STA Compact" are in bold, and the "®" symbol is a registered trademark symbol. The number in parentheses is likely a product or model number.
Image /page/1/Picture/10 description: The image shows a large, box-shaped machine with a light gray exterior. The machine has a section with horizontal ventilation slats on the left side. To the right of the ventilation section, there is a curved design element that frames a dark, enclosed area, possibly a viewing window or operational space.
2
D. Indication/Intended Use
The STA Compact Max is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
E. Purpose of the Special 510(k) Notice
The STA Compact Max® is a modification to the company's own legally marketed device, STA Compact® (K093167).
The modifications of the device involve:
- Change of the on-board computer to allow the use of current technologies - 1 for data transfer (USB, DVD), without any change in the technology or mechanical operation by which samples are processed.
- -2-Change of the operating system: from DOS for the predicate device to Windows for the STA Compact Max .
- Migration of the user/application software to accommodate the new -3operating system, the use of new peripherals (USB, DVD, touch screen) and update the graphical user interface without modification of specifications and functionalities.
- Change of the external design (colors and shape) of the analyzer to -4refresh external aspect.
F. Description of the device
Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.
The device consists of the following components:
- 1 a cuvette, which holds the patient sample and any needed reagent;
- -2a metal ball located in the cuvette, that is induced to oscillate to measure coagulation;
- -3three needles that will aspirate and dispense the patient's sample and reagents into the cuvette;
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
-5a light source and sensor to transmit light through the cuvette containing the sample and reagents that subsequently measures the light absorbed as a reaction takes place;
- Software which conducts the measurement and test determination; -6-
3
1) Principles of Operation
STA Compact Max® is a fully automatic clinical laboratory analyzer. 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 wave lengths) on plasma samples.
Fundamental technologies 2)
The proposed device has same fundamental technological characteristics as the predicate device based on the following:
. . Chronometry Measurement Principle
The principle consists in measuring the variations of the ball oscillation amplitude through inductive sensors. The ball has a pendular movement obtained:
-
thanks to the two curved rail tracks of the cuvettes
-
and an alternate electro-magnetic field created by two independent . coils.
The oscillation amplitude is constant when the environment has a constant viscosity. The oscillation amplitude decreases when the environment viscosity increases as shown in Schema 1.
Image /page/3/Figure/13 description: The image shows a diagram of the amplitude of a ball oscillation during clotting. The diagram shows a U-shaped container with three balls inside, oscillating back and forth. Below the container is a graph showing the amplitude of the ball oscillation over time, with the amplitude decreasing as clotting occurs. The graph is labeled with "Amplitude of the ball oscillation" and "Clotting".
Schema 1: Amplitude of the ball oscillation during clotting
4
Photometry Measurement Principle ●
The detection of chromogenic assays is based on the absorbance (optical density: O.D) of monochromatic light passing through the cuvette as a chromogenic reaction takes place.
Incident light entering the cuvette is partially absorbed by the reaction mixture as it passes through. The transmitted light is measured, and converted to absorbance. The Beer-lambert law is applied to convert absorbance to concentration of the substance being measured. The principle of absorbance measurement is depicted by the Schema 2.
Schema 2: Measurement principle of absorbance
Image /page/4/Picture/7 description: The image shows a diagram of light passing through a liquid in a container. There are three light intensities labeled in the image: I0, Ip, and Ih. The light intensity Ih is equal to the sum of I and Ip. There is also a small square in the upper right corner of the image with some numbers in it.
G. Substantial Equivalence
The STA Compact Max® and its Predicate Device, STA Compact® (K093167) have the same Indications for Use, Technology, Principles of Operation and comparable Performances as described in Table 1.
| Characteristics or
Attributes | Diagnostica Stago, STA
Compact Max® | Diagnostica Stago, STA
Compact® |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | 510(k) subject device | K093167 |
| Indications for
Use/Intended Use | The STA Compact Max® 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. | The STA Compact® 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. |
| Target Population | To aid in the diagnosis of
coagulation abnormalities or
in monitoring anticoagulant
therapy in patients | To aid in the diagnosis of
coagulation abnormalities or
in monitoring anticoagulant
therapy in patients. |
| Table 1: Substantial Equivalence Comparison | |||||
|---|---|---|---|---|---|
| --------------------------------------------- | -- | -- | -- | -- | -- |
5
Diagnostica Stago, Inc STA Compact Max®
| Anatomical Sites | In vitro testing of human
plasma | In vitro testing of human
plasma |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Point of use | Hospital Laboratory or other
Health Care Laboratory. | Hospital Laboratory or other
Health Care Laboratory. |
| Fundamental Scientific
Technology | There is no change in the
Fundamental Scientific
technology used. No new
question generated. | No new questions
demonstrated in K093167. |
| Chronometric Method of
Coagulation Detection | Mechanical measurement of
the oscillation of the metal
ball in the cuvette. | Mechanical measurement of
the oscillation of the metal
ball in the cuvette. |
| Photometric method of
Coagulation Detection | Light absorption technique
provided by a filtered light
source. | Light absorption technique
provided by a filtered light
source. |
| Design Control | Design Controls: Verification
and Validation utilized. | Design Controls: Verification
and Validation utilized. |
| Electrical Safety | UL Listed. | UL Listed. |
| Performance | Same as Predicate Device | See K093167 |
The specific differences between the instruments are the on-board computer, to allow the use of Windows operating system, new peripherals (USB, CD/DVD), and the migration of the application software with a new graphical user interface. The purposes are to improve the ease of use, to include operator/user use enhancements and to manage obsolescence (See Table 2). These modifications don't change, delete or add functionalities.
The modifications of external design: color and shape, are only a marketing purpose, and has no impact on performances, principles of operation or fundamental technologies.
| Features | STA Compact Max® | STA Compact®
Predicate Device K093167 | |
|------------------------------------|------------------|--------------------------------------------------|------------------------------------------------|
| Dimensions | Height | 705 mm (27.75 in) | 640mm (26.5 in) |
| | Width | 970 mm (38.18 in) | 975mm (38.4 in) |
| | Depth | 730 mm (28.73 in)
lower part 685 mm (26.97in) | 720mm (28.3 in)
lower part 657 mm (25.9 in) |
| Weight | | 140 kg (331 lbm) | 140 kg (331 lbm) |
| Barcode ID of samples and reagents | | Yes | Yes |
| Integrated PC | | Yes | Yes |
| Connections | | USB, RJ45, Port parallel | Port parallel |
| Disk | | CD/DVD disk | floppy disk |
| Touch Screen | | Yes | No |
| Optical Wavelengths | | 405μm, 540μm | 405μm, 540μm |
| Mechanical clotting | | Yes | Yes |
| Disposables | | identical | identical |
Table 2: Minor Modifications comparison
6
Firmware versions of STA Compact Max® and its predicate device, STA Compact® are strictly identical as described below.
| Name | Version | Description |
|---|---|---|
| MSTB | V1.00 | Measurement |
| GSTB | V4.72 | Management of the measurement and its |
| environment | ||
| ISTB | V3.10 | Identification of the products and sample |
| (controlling barre code reader) | ||
| CSTB | V10.42 | Needles control (z axis). |
| V1.81 | Needles control (z axis) with cap piercing | |
| MPP | V2.81 | Arms and pipetting control |
Table 3: Firmware versions shared by STA Compact Max® and STA Compact®
Conclusion
The STA Compact Max and its Predicate Device, STA Compact® (K093167), have the same Intended Use/Indications for Use, same fundamental technological characteristics, principles of operation and comparable performances characteristics. The modifications consist in a new PC on-board computer, with new operating system, new peripherals, a new graphical user interface to include operator/user use enhancements and to improve easy to use.
As evidenced by Risk Assessment and Validation Studies, no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation. Therefore, The STA Compact Max® is substantially equivalent to the STA Compact® Predicate Device.
7
: ·
, .
Attachment_05
Proposed Labeling
| Symbol | Meaning |
|---|---|
| Image: Alternating current symbol | Alternating current |
| Image: Direct current symbol | Direct Current |
| Image: Protective conductor terminal symbol | Protective conductor terminal |
| Image: Off (Power) symbol | Off (Power) |
| Image: On (Power) symbol | On (Power) |
| Image: Caution, risk of electric shock symbol | Caution, risk of electric shock |
| Image: Caution, hot surface symbol | Caution, hot surface |
| Image: Caution, consult documentation symbol | Caution, consult the provided documentation for important cautionary |
| information such as warnings and precautions | |
| Image: Caution, biological risks symbol | Caution, biological risks |
| Image: In vitro diagnostic medical device symbol | In vitro diagnostic medical device |
| Image: Medical device manufacturer symbol | Medical device manufacturer |
| Image: Separate collection symbol | Separate collection: do not discard with other waste. |
| Image: Hourglass symbol | For additional information about the disposal procedure, see chapter |
| 1.8. |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/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" around the perimeter. Inside the circle is a stylized design featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being.
Public Health Service
February 12, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Diagnostica Stago, Inc. c/o Mr. Carlo d'Alessandro. Director, IVD Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10 Rome, Italy 00153
Re: K130090
Trade/Device Name: STA Compact Max® Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: January 11, 2013 Received: January 18, 2013
Dear Mr. d'Alessandro:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
9
Page 2 - Mr. Carlo d'Alessandro
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,
Maria Mix Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
10
Attachment 01
Indications for Use
K130090 510(k) Number (if known):
STA Compact Max®
Indications for Use:
Device Name:
The STA Compact Max® is a fully automatic clinical analyzer 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 (OIVD)
Sereh
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K130090