(29 days)
No
The summary describes a standard clinical laboratory analyzer for coagulation testing and does not mention any AI or ML components or capabilities.
No.
The device is an in vitro diagnostic (IVD) device used to perform tests that aid in diagnosis and monitoring, not to provide therapy.
Yes
The device is described as "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." This explicitly states its role in aiding diagnosis.
No
The device description explicitly lists multiple hardware components (cuvette, metal ball, needles, oscillation amplitude detection, light source and sensor) in addition to software.
Yes, based on the provided information, the STA R Max® is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to perform 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 are devices used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description confirms it's a "fully automatic clinical laboratory" that performs tests on human plasma to aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. This further supports its role in in vitro testing for diagnostic purposes.
- Anatomical Site: The anatomical site is listed as "In vitro testing of human plasma," which is a key characteristic of IVD devices.
Therefore, the STA R Max® clearly fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA R Max® 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
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.
The device consists of the following components:
- -1a 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;
- three needles that will aspirate and dispense the patient's sample and reagents into -3the cuvette:
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
- -2a 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing right, suggesting a sense of community and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Diagnostica Stago, Inc. James Monroe Regulatory Project Manager 5 Century Drive Parsippany, NJ 07054
Re: K151867
Trade/Device Name: STA R Max® Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: June 29, 2015 Received: July 10, 2015
Dear Mr. Monroe:
This letter corrects our substantially equivalent letter of August 7, 2015.
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
1
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 medical 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 Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name STA R Max®
Indications for Use (Describe)
The STA R Max® 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/14 description: The image features the logo for Stago, a company specializing in in-vitro diagnostics. The logo consists of the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is an abstract graphic element, featuring a red shape resembling a stylized flame or leaf, positioned next to a gray teardrop shape. The overall design is clean and professional, reflecting the company's focus on healthcare and diagnostics.
Attachment_09
510(k) Summary
STA R Max®
| A. 510(k) Submitter information | ||
|---|---|---|
| B. Device Information | ||
| C. Predicate Device Information | ||
| D. Indication/Intended Use | ||
| E. Purpose of the Special 510(k) Notice | ||
| F. Description of the device | ||
| 1) | Principles of Operation | |
| 2) | Fundamental technologies | |
| G. Substantial Equivalence |
A. 510(k) Submitter information
| Submitter's name | Diagnostica STAGO S.A.S |
|---|---|
| 125 Avenue Louis Roche | |
| Address | 92230 Gennevilliers |
| France | |
| Phone Number | +33 1 46 85 48 80 |
| Fax Number | +33 1 41 47 57 50 |
| Date of Preparation | 06/29/2015 |
Application Correspondent and Contact Person information
| Name | James Monroe |
|---|---|
| Address | 5 Century Drive |
| Parsippany, New Jersey 07054 | |
| Phone Number | +1-973-631-1200 x 4306 |
| Fax Number | +1-973-775-8063 |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
4
B. Device Information
| Device Trade Name | STA R 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 |
| Picture 1: STA R Max® | |
|---|---|
| ----------------------- | -- |
Image /page/4/Picture/6 description: The image shows a large, automated laboratory analyzer and a computer workstation. The analyzer is white and gray with a blue-tinted window, and it has a sample loading area on the left side. The computer workstation includes a monitor, keyboard, mouse, and barcode scanner, all mounted on a rolling stand. The analyzer is likely used for high-throughput clinical chemistry or immunoassay testing.
C. Predicate Device Information
| 510(k) Number | K093001 |
|---|---|
| Device Trade Name | STA-R Evolution® Expert Series |
| Device Common Name | STA-R Evolution® Expert Series |
| 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 |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
5
Image /page/5/Picture/3 description: The image shows a STA-R Evolution Expert Series machine, identified by the code (K093001). It features a monitor at the top, displaying a graphical user interface with various icons and data points. The machine has a modular design with different sections, including a sample loading area and a processing unit, all mounted on wheels for mobility.
Picture 2: STA-R Evolution® Expert Series
D. Indication/Intended Use
The STA R Max® 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.
E. Purnose of the Snecial 510(k) Notice
The STA R Max® is a modification to the company's own legally marketed device, STA-R Evolution® Expert Series (K093001).
The modifications of the device involve:
- Implementation of a new graphical user interface (GUI) to use the graphical chart -1of Max line of STA Analyzers.
6
- -2-Changes to the external design (colors and shape) of the analyzer which include modifications of the openings and the addition of a new computer table for improved ergonomics.
- -3-Improvement of the communication protocol with a LIS or a middleware so more information can be exchanged.
F. Description of the device
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.
The device consists of the following components:
- -1a 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;
- three needles that will aspirate and dispense the patient's sample and reagents into -3the cuvette:
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
- -2a 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-
Principles of Operation 1)
The principles of operation are the same as described for STA -R Evolution® Expert Series (predicate device) in submission, K093001. A brief summary follows:
-
The STA R Max® 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, system supervision, support for instrument maintenance, and workload optimization.
-
The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators and controls
7
facilitate their use on the system and facilitates reagent management. Manual entry of reagent information enables the use of non-barcoded-reagents.
-
There are two methods used by the instrument to measure coagulation: the chronometric (clotting time or clot-based measurements) and photometric assays (at specific wave lengths) on plasma samples.
2) Fundamental technologies
The Technological characteristics are the same for the STA R Max® and the STA-R Evolution® Expert Series
● 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:
- due to the two curved rail tracks in the bottom of the cuvettes
- and an alternating electromagnetic field generated by two independent drive coils.
The oscillation amplitude is constant when the viscosity of the medium through which the ball moves remains constant.
The oscillation amplitude decreases when the viscosity of this medium increases as shown in Schema 1.
Image /page/7/Figure/13 description: The image shows a diagram of a ball oscillating in a container, along with a graph of the amplitude of the ball's oscillation over time. The graph shows that the amplitude of the ball's oscillation decreases over time, eventually leading to clotting. The x-axis of the graph is labeled "Amplitude of the ball oscillation", and the y-axis is labeled "T".
Schema 1: Amplitude of the ball oscillation during clotting
- Photometry Measurement Principle
The detection principle for chromogenic or immunological analyses on the STA R Max® is based on the absorbance (optical density, O.D.) of monochromatic (405 nm or 540 nm) light passing through a cuvette as an enzymatic or immunological reaction takes place.
8
The principle underlying the measurement of absorbance is depicted in the Schema 2 below:
Image /page/8/Figure/4 description: The image contains the text "Schema 2: Measurement principle of absorbance". The text appears to be a title or heading, possibly indicating the subject matter of a diagram or explanation related to the measurement principle of absorbance. The text is written in a formal font.
Image /page/8/Picture/5 description: The image shows a diagram of a container with liquid and arrows indicating light intensity. The arrows are labeled I0, Ip, and I1=I+Ip, representing different light intensities. In the upper right corner, there is a table showing DO values with corresponding numbers 0, 1, and 2, and values of 1, 1.0, and 100.
Incident light (lo) entering the cuvette is partially absorbed by the reaction medium as it passes through.
The transmitted light (I1 = I + Ip) is measured.
The effect of stray light (lo) is eliminated by taking two measurements of transmitted light within a brief interval:
I1 = I + In (first measurement which includes incident light and stray light)
I2 = Io (second measurement, while blocking incident light, corresponds to the stray light)
l2 is subtracted from 11 to obtain I, which corresponds to light resulting only from incident light. Stray light (In) is assumed to remain constant between the two measurements.
The absorbance is calculated using the following equation: A = -log(I/Io) note: log decimal
Monochromatic incident light (lo) is produced by passing light from a tungstenhalogen lamp through a 405 nm or 540 nm monochromatic filter, placed in a mobile filter holder.
These parts are located inside the optical module. The monochromatic light is directed from the optical module to the measurement heads by optical fibers, then another set of optical fibers carries the light from the measurement heads to the photometry measurement board.
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
9
G. Substantial Equivalence
The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001) have the same Indications for Use, Technology, Principles of Operation and comparable Performances as described in Table 1.
| Table 1. Substantial Equivalence Comparison | ||
|---|---|---|
| Characteristics
or Attributes | Diagnostica Stago,
STA R Max® | Diagnostica Stago,
STA-R Evolution®
Expert Series | Identical/
Different | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------|
| 510(k) number | 510(k) subject device | K093001 | N/A | |
| Indications for
Use/Intended
Use | The STA R 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-R Evolution®
Expert Series 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. | Identical | |
| 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. | Identical | |
| Anatomical
Sites | In vitro testing of human
plasma | In vitro testing of
human plasma | Identical | |
| Point of use | Hospital Laboratory or other
Health Care Laboratory. | Hospital Laboratory or
other Health Care
Laboratory. | Identical | |
| 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. | Identical | |
| Photometric
method of
Coagulation
Detection | Light absorption technique
provided by a filtered light
source (405μm, 540μm). | Light absorption
technique provided by
a filtered light source
(405μm, 540μm). | Identical | |
| Characteristics
or Attributes | Diagnostica
Stago, STA R
Max® | Diagnostica Stago,
STA-R Evolution®
Expert Series | Identical/
Different | |
| Electrical Safety | UL Listed.
- IEC 61010-2-
101:2003 - Safety
requirements for
electrical equipment for
measurement, control
and laboratory use –
Part 2-101: Particular
requirements for in
vitro diagnostic (IVD)
medical equipment. | UL Listed. - IEC 61010-2-
101:2003 - Safety
requirements for
electrical equipment for
measurement, control
and laboratory use –
Part 2-101: Particular
requirements for in vitro
diagnostic (IVD)
medical equipment. | Identical | |
| Dimensions | Height | 1265 mm | 1250 mm | Different |
| | Width | 1220 mm | 1280 mm | Different |
| | Depth | 805 mm | 820 mm | Different |
| Integrated
PC | µproces
sor | Intel Celeron M423
1.06 GHz | Pentium MMX
(200MHz Min) | Different |
| | Memor
y | 1 GB | 64Mb (Min) | Different |
| | Hard
disk | 80 GB | 2.4 GB (Min) | Different |
| Weight | | 238 kg | 226 kg | Different |
| Barcode ID of samples and
reagents | | Yes | Yes | Identical |
| Connections | | RS232, USB, RJ45 | RS232 | Different |
| Disk | | None (external USB
CD/DVD optional) | CD/DVD recorder,
floppy disk | Different |
| Computer table | | Yes (with 6 x 2.0
USB ports to connect
the following USB
peripheral devices:
keyboard, mouse,
touchscreen, printer,
USB flash drive) | Yes (unconnected) | Different |
| Touch Screen | | Yes | Yes (optional) | Different |
| Disposables | | identical | identical | Identical |
This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization
10
Image /page/10/Picture/1 description: The image shows the logo for Stago, a company that specializes in in-vitro diagnostics. The logo features the company name "Stago" in a serif font, with the "S" slightly larger than the other letters. Above the name is an abstract graphic element in two colors: red and gray. The red portion is shaped like a curved triangle, while the gray portion resembles a crescent shape.
Comparison between the predicate and subject devices have minor differences. The differences are a result of the obsolescence of computer peripherals such as floppy discs, computer processors, and the addition of the new graphic interface and evolution of the communication protocol have no impact on performance, principle of operation, or
11
Image /page/11/Picture/1 description: The image shows the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is a stylized graphic element that resembles two overlapping shapes, one red and one gray. The red shape is positioned slightly above and to the left of the gray shape, creating a sense of depth.
fundamental technology. The modifications of external design (e.g. color, weight, dimension, and shape) are ergonomic and cosmetic enhancements, which neither affect the fundamental technology, nor raise any new questions of safety and effectiveness. Thus the two devices are substantially equivalent with respect to their key attributes.
Conclusion
The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001), have the same Intended Use/Indications for Use, same fundamental technology, same principles of operation, and comparable performance characteristics. The modifications consist of changes to the software (to integrate a new graphical user interface and a new communication protocol), new peripherals, and new external shape (for ergonomic improvements).
As evidenced by risk assessment and verification and validation activities, no new questions of safety and effectiveness were raised. Therefore we believe, the STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device.