(694 days)
No
The summary describes a clinical analyzer performing standard coagulation and photometric tests. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "HIL module for estimating interferences" is described as a standard analytical function, not an AI/ML application.
No.
The device is an in-vitro diagnostic (IVD) clinical analyzer used for diagnostic purposes, not for treating a condition or disease.
Yes
The device is described as "fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous 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 states it is a "fully automatic clinical analyzer" and details hardware components like a "redesigned PSR module" and "HIL module," indicating it is a physical device with integrated software, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Intended Use: The text explicitly states the devices are "designed to be used by professional laboratory personnel and to perform tests on human venous plasmas... the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy." This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description reinforces the intended use by stating the analyzers "perform tests on human venous plasmas" and are used with "Diagnostica Stago reagents in addition to open adaptation of other available reagents." This further confirms its role in analyzing biological samples.
- Anatomical Site: The "Anatomical Site" section explicitly states "In vitro testing of human plasma," which is a key characteristic of an IVD.
The definition of an In Vitro Diagnostic device generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for diagnostic purposes. The STA R Max 3 and STA Compact Max 3 fit this definition perfectly.
N/A
Intended Use / Indications for Use
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) 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 30 analyzers are modified versions of the STA R Max® analyzer, originally cleared for marketing by the FDA under K151867 as an in-vitro diagnostic device.
The STA-R family of analyzers is composed of:
- STAR® cleared in 1998: K983460
- . STA-R Evolution® cleared in 2008: K082675
- . STA-R Evolution® Expert Series cleared in 2009: K093001
- . STA R Max® cleared in 2015: K151867
All these analyzers are fully automatic systems designed to perform tests on human plasmas and to study coagulation parameters.
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 the instrument such as, management of patient results, quality control, system supervision, support for instrument maintenance and workload optimization.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available 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 measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all STA R Max® family of analyzers (VOL_013, Labeling).
Diagnostica Stago's STA Compact Max®3 analyzers are modified versions of the STA Compact Max® analyzer, originally cleared for marketing by the FDA under K130090 as an in-vitro diagnostic device.
The STA Compact® family of analyzers is composed of:
- STA Compact cleared in 1996: K961579, K093167
- STA Compact with Cap piercing Options cleared in 1996, with an add to file
- . STA Compact Max cleared in 2013: K130090
All these analyzers are fully automatic systems designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Once samples and test reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of results are performed automatically. A central processing unit controls instrument functions, including management of patient's results, quality control, scheduling of instrument maintenance and workload organization.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available 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 measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all Compact Max® family of analyzers (VOL_013, Labeling).
To facilitate in user maintenance and manufacturing process, the PSR module has been designed to replace the Hamilton syringes and Valcor pump of the fluidic circuit on all Diagnostica Stago analyzers.
The HIL module is a detection module developed to estimate interferences (Hemoglobin, Icterus, Lipemia) which may affect chromogenic and immune-turbidimetric tests. The analysis is performed before delivery in the cuvette and provides results of an index of interferences concentration to the biologist (display of the data on screen monitor). The plasma sample is not altered during HIL evaluation.
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
professional laboratory personnel / clinical central/hospital 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
Method comparison studies designed according to CLSI EP09c recommendations were conducted at three external sites for STA R Max 3 and STA Compact Max 3. Samples were selected to cover the entire measuring range of each assay.
A method comparison study for HIL was performed at one site in accordance with CLSI EP09c guideline, comparing the STA R Max 3 to cobas® 8000 modular analyzer (Hemolysis, Icterus, and Lipemia) and spectrophotometer (Lipemia).
Single-site precision testing was performed in accordance with CLSI EP05-A3 over 20 days at one external site. Three samples per parameter were tested across the applicable measuring ranges, with two runs per day and two replicates per day. Each run was at least two hours apart.
Multi-site precision testing was performed in accordance with CLSI EP05-A3 over 5 days at three external sites. Three samples per parameter were tested across the applicable measuring ranges, with two runs per day and two replicates per day. Each run was at least two hours apart.
The HIL interferences study assessed cross-interferences by spiking plasma with hemoglobin, bilirubin and lipids (Intralipid®) at various concentrations to provide combinations of HIL concentrations. Each spiked plasma concentration was assayed in triplicate on two subject devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: STA R Max 3
Conducted at three external sites. Results were compared by either Passing & Bablok or Deming regression analysis.
- STA - Neoplastine CI Plus: Slope 0.98 (0.97 to 0.98), Intercept 0.20 sec (0.06 to 0.30), rSpearman 0.997 (0.996 to 0.998)
- STA - PTTA: Slope 1.00 (0.98 to 1.01), Intercept -0.32 (-1.02 to 0.32), rSpearman 0.997 (0.996 to 0.998)
- STA - Fibrinogen: Slope 1.01 (0.99 to 1.03), Intercept 4.26 mg/dL (-1.83 ; 10.14), rSpearman 0.996 (0.995 to 0.997)
- STA - Stachrom ATIII: Slope 1.03 (1.00 to 1.07), Intercept -1.03% (-3.15 ; 2.00), rSpearman 0.980 (0.972 to 0.985)
- STA - Liatest D-DI: Slope 1.02 (1.01 to 1.03), Intercept -0.02 µg/mL (-0.04 ; 0,01), rSpearman 0.998 (0.998 to 0.999)
Method Comparison: STA Compact Max 3
Conducted at three external sites. Results were compared by either Passing & Bablok or Deming regression analysis.
- STA - Neoplastine CI Plus: Slope 0.99 (0.98 to 1.00), Intercept 0.20 sec (0.05 to 0.35), r Spearman 0.994 (0.993 to 0.996)
- STA - PTTA: Slope 0.99 (0.97 to 1.00), Intercept 0.06 sec (-0.56 to 0.81), rSpearman 0.996 (0.995 to 0.997)
- STA - Fibrinogen: Slope 1.01 (1.00 to 1.03), Intercept 4.94 mg/dL (0.67 to 11.25), rSpearman 0.995 (0.993 to 0.996)
- STA - Stachrom ATIII: Slope 1.00 (1.00 to 1.03), Intercept 0.00% (-1.63 to 0.00), r Spearman 0.981 (0.975 to 0.986)
- STA - Liatest D-DI: Slope 1.02 (1.01 to 1.03), Intercept -0.01 μg/mL (-0.04 to 0.01), r Spearman 0.997 (0.996 to 0.998)
Method Comparison: HIL
Compared to cobas® 8000 and spectrophotometer.
- Hemolysis: Slope 1.12 (1.08 to 1.19), Intercept -0.03 g/L (-0.06 to -0.01), R Spearman 0.954 (0.916 to 0.975) (with outliers); Slope 1.11 (1.07 to 1.14), Intercept -0.03 g/L (-0.05 to -0.01), R Spearman 0.948 (0.904 to 0.972) (without outliers)
- Icterus: Slope 0.99 (0.96 to 1.07), Intercept 0.26 mg/dL (0.02 to 0.48), R Spearman 0.956 (0.920 to 0.976)
- Lipemia: Regression coefficient (r) 0.91 (versus Spectrophotometer); Regression coefficient (r) 0.97 (versus cobas 8000)
Precision/Reproducibility
- Single-site precision testing: Performed for STA R Max 3 and STA Compact Max 3 for five assays. Acceptance criteria were met for all samples. Detailed tables of SD and CV(%) for Within-Run, Between-Run, Between-Day, Between-Instrument, and Within-Site were provided for each assay and sample.
- Multi-site precision testing: Performed for STA R Max 3 and STA Compact Max 3 for various assays. Acceptance criteria were met for all samples. Detailed tables provide SD and CV(%) for Within-Run, Between-Run, Between-Day, Between-Site, and Total Precision for each assay and sample.
HIL Interferences
All results obtained matched the index determination for the subject devices and the theoretical index.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (for clinical sensitivity/specificity)
Regression slopes, intercepts, and Spearman correlation coefficients (rSpearman), Standard Deviation (SD) and Coefficient of Variation (CV%) for precision.
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.
No reference devices were used in this submission.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2023
Diagnostica Stago SAS % Anthony Dennis Director of US Market Access Diagnostica Stago Inc. 5 Century Drive Parsippany, New Jersey 07054
Re: K212183
Trade/Device Name: STA R Max 3, STA Compact Max 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: September 30, 2022 Received: October 5, 2022
Dear Anthony Dennis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image contains the text "Min Wu-S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. In the background, there is a faint, light blue watermark of the letters "FDA".
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212183
Device Name STA R Max 3® and STA Compact Max 3®
Indications for Use (Describe)
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be three curved shapes, one red and two brown, arranged in a circular pattern. The overall design is simple and modern.
510(k) SUMMARY
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92 and follows FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.
1. Submitter
Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ 07054 Primary Contact: Anthony Dennis, RAC, CBA (ASQ), MBA Director, US Market Access Phone: 1 - (973) - 775-1200 x4162
On Behalf of: Diagnostica Stago SAS
Date: 12 July 2021; Revised 05 June 2023
2. Device
| Device Name: | STA R Max 3® / STA Compact Max 3® |
|---|---|
| Common Name: | Automated Coagulation Analyzer |
| Classification Name: | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class: | Class II |
| Panel: | Hematology |
| Product Code: | JPA |
| Regulation Number | 21 CFR 864.5424 |
Note that as a successor of earlier instruments in their respective families, reference to "STA R Max 3" or "Compact Max 3" is in reference to these families of analyzers with the aforementioned improvements. As such, elements in this submission, such as the intended use below are not version specific.
Intended Use:
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
3. Predicate Device
| Device Name: | STA R Max® (K151867) / STA Compact Max® (K130090) |
|---|---|
| Common Name: | Automated Coagulation Analyzer |
| Classification Name: | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class: | Class II |
| Panel: | Hematology |
| Product Code: | JPA |
| Regulation Number | 21 CFR 864.5424 |
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Image /page/4/Picture/0 description: The image contains the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be an abstract shape in two colors, red and brown, possibly representing a drop or a leaf.
The predicate has not been subject to design-related recalls for any of the applications associated with this premarket notification. No reference devices were used in this submission.
4. Device Description / Test Principle
4.1.1. STA R Max 30 and STA Compact Max 30 Test Principle
The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles.
Chronometric measurement principle:
The principle consists of measuring the variation of the metal ball oscillation amplitude through inductive sensors. The ball has a pendula movement due to an alternating electromagnetic field generated by two independent drive coils and two curved rail tracks in the bottom of the cuvettes. The oscillation amplitude is constant when the viscosity of the reaction volume in the cuvette remains constant.
The oscillation amplitude decreases when the viscosity of the reaction volume in the cuvette increases. The amplitude of the oscillation ball is analyzed to determine coagulation time in the cuvette.
. Photometry measurement principle:
The principles consists of measuring the variation of absorbance (optical density, O.D.) of monochromatic light (405 nm or 540 nm) passing through a cuvette as an enzymatic or immunological reaction takes place.
The variation of absorbance is analyzed to determine enzymatic activity or quantification (by immune aggregation) of factors related to coagulation.
4.1.2. STA R Max 3® Device Description
Diagnostica Stago's STA R Max 30 analyzers are modified versions of the STA R Max® analyzer, originally cleared for marketing by the FDA under K151867 as an in-vitro diagnostic device.
The STA-R family of analyzers is composed of:
- STAR® cleared in 1998: K983460 ●
- . STA-R Evolution® cleared in 2008: K082675
- . STA-R Evolution® Expert Series cleared in 2009: K093001
- . STA R Max® cleared in 2015: K151867
All these analyzers are fully automatic systems designed to perform tests on human plasmas and to study coagulation parameters.
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 the instrument such as, management of patient results, quality control, system supervision, support for instrument maintenance and workload optimization.
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Image /page/5/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be two curved shapes, one red and one brown, arranged to suggest a drop or abstract form. The word "Stago" is in a bold, sans-serif font.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available 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 measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all STA R Max® family of analyzers (VOL_013, Labeling).
4.1.3. STA Compact Max 3® Device Description
Diagnostica Stago's STA Compact Max®3 analyzers are modified versions of the STA Compact Max® analyzer, originally cleared for marketing by the FDA under K130090 as an in-vitro diagnostic device.
The STA Compact® family of analyzers is composed of:
- STA Compact cleared in 1996: K961579, K093167 ●
- STA Compact with Cap piercing Options cleared in 1996, with an add to file •
- . STA Compact Max cleared in 2013: K130090
All these analyzers are fully automatic systems designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Once samples and test reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of results are performed automatically. A central processing unit controls instrument functions, including management of patient's results, quality control, scheduling of instrument maintenance and workload organization.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available 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 measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all Compact Max® family of analyzers (VOL_013, Labeling).
4.1.4. Change to Control of Fluidic System and Addition of HIL Module
To facilitate in user maintenance and manufacturing process, the PSR module has been designed to replace the Hamilton syringes and Valcor pump of the fluidic circuit on all Diagnostica Stago analyzers.
The HIL module is a detection module developed to estimate interferences (Hemoglobin, Icterus, Lipemia) which may affect chromogenic and immune-turbidimetric tests. The analysis is performed before delivery in the cuvette and provides results of an index of interferences concentration to the biologist (display of the data on screen monitor). The plasma sample is not altered during HIL evaluation.
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Image /page/6/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be two curved shapes, one red and one brown, arranged to suggest a drop or abstract form. The word "Stago" is in a serif font.
4.1.5. Reagent Applications in this 510(k) Notification
Five assays were used to demonstrate substantial equivalence, i.e. STA® - Neoplastine CI Plus (10), STA® - PTTA (5), STA® - Fibrinogen (5), STA® - Stachrom® ATIII (6) and STA® -Liatest DDi. These assays cover the three measuring principles, i.e. chronometric, chromogenic and immuno-turbidimetric, and the different reaction set-ups regarding sample dilution (undiluted or diluted) and reagents (use of only the third needle for reagent, or use of both second and third needles for reagent). The table below describes the configuration used for each assay.
| Assay | Measuring
Principle | Sample Dilution
Set-Up | Reagent Set-up | Prior
regulatory
clearance (K#) |
|---------------------------------|--------------------------|---------------------------|-----------------------------------------|---------------------------------------|
| STA® - Neoplastine CI Plus (10) | Chronometric | Undiluted | Only the third
needle | K922040 |
| STA® - PTTA (5) | Chronometric | Undiluted | Second and third
needles for reagent | K861190 |
| STA® - Fibrinogen (5) | Chronometric | Diluted | Only the third
needle | K840211 |
| STA® - Stachrom ATIII (6) | Chromogenic | Diluted | Second and third
needles for reagent | K832592 |
| STA® - Liatest DDi | Immuno-
turbidimetric | Undiluted | Second and third
needles for reagent | K162227 |
| Table 1: Description of the test configurations for the assays used for validation | ||
|---|---|---|
The intended Environment of Use is a clinical central/hospital laboratory.
5. Substantial Equivalence
| Attributes or Characteristics | Predicate Device
STA R Max (K151867) | Candidate Device
STA R Max 3 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Classification | JPA, Class II
System, Multipurpose for in vitro
coagulation studies | Same |
| 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. | The STA R Max 3® and STA Compact
Max 3® are fully automatic clinical
analyzers designed to be used by
professional laboratory personnel and to
perform tests on human venous plasmas
(in 3.2% trisodium citrate tubes) the
results of which aid in the diagnosis of
coagulation abnormalities or in
monitoring anticoagulant therapy. |
| Anatomical Sites | In vitro testing of human plasma | Same |
| Sample Matrix | Human plasma
3.2% sodium citrate | Same |
| Where Used: hospital, home,
ambulance, etc. | Hospital Laboratory or other Health Care
Laboratory. | Same |
| Attributes or Characteristics | Predicate Device
STA R Max (K151867) | Candidate Device
STA R Max 3 |
| Measurement Principle | Chronometric method (clotting time):
mechanical measurement of the
oscillation of the metal ball placed in the
cuvette
Photometric method: light absorption
technique provided by a filtered light
source
(405nm, 540nm). | Same |
| Cap Piercing | Available as an option | Available as an option with HIL pre-
analytical module.
New needle connector, new cap
piercing foot and evolution of the lock
system. |
| Control of Fluidic
System | Valcor pump and Hamilton syringes | PSR (Pipettor Simple Resolution)
in replacement of Valcor pump
and Hamilton syringes |
| Needles | One sample, Two reagent | Same |
| Operating Environment
Temperature | 59° - 89.5°F | Same |
| User/Patient Data Input | Touchscreen, keyboard, and/or barcode
scanner | Same |
| Specimen Processing | Automatic pipetting and dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes | Same |
| Stat Testing | Yes | Same |
| Parameters | Prothrombin Time (PT) seconds, PT INR,
Activated Partial Thromboplastin Time
(APTT), Fibrinogen, Thrombin Time
(TT), Reptilase, Extrinsic pathway
factors, Intrinsic pathway factors, Anti-Xa
(UFH, LMWH), Antithrombin (AT)
activity, D-Dimer, Protein C activity,
Protein S activity, Free Protein S antigen,
Lupus anticoagulant, vWF antigen,
Plasminogen | Same |
| Attributes or Characteristics | Predicate Device
STA R Max (K151867) | Candidate Device
STA R Max 3 |
| HIL Pre-analytical
Module | Not available | Avalable as an option: Semi quantitative
determination of hemolysis, icterus and
Lipemia (HIL) in patient plasma, reported
as indices according to CLSI C56-A
document. No predefined alerts are set-up
in the analyzer; users are responsible for
setting thresholds according to practices.
Any evaluation of indices as potential
interfering substances are left to the end
users. |
| Data Storage Capacity | 160 GB | 320 GB |
| Software | Windows XP | Windows 10 |
| Cybersecurity | In 2019, Stago implemented a new PC-
Gen with a new Windows 10 Operating
System (OS), updated software, and the
introduction of cybersecurity via internal
documentation agreed with FDA during
Q181507. | Introduced with user account management
(reinforced passwords, restrictive access,
log history...), firewall, antivirus, and
data encryption. |
Table 2: STA R Max 3 Similarities Between Candidate and Predicate Devices
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Image /page/7/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a red, serif font. Above the word is an abstract graphic element. The graphic element is composed of two curved shapes, one red and one brown, that appear to be overlapping or intertwined.
8
Image /page/8/Picture/0 description: The image shows the logo for Stago. The logo features the word "Stago" in red, with a stylized graphic above it. The graphic consists of two curved shapes, one red and one brown, that appear to be overlapping or interacting with each other. The overall design is simple and modern.
Table 3: STA R Max 3 Differences Between Candidate and Predicate Devices
Table 4: STA Compact Max 3 Similarities Between Candidate and Predicate Devices
| Attributes or Characteristics | Predicate Device
STA Compact Max (K130090) | Candidate Device
STA Compact Max 3 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Classification | JPA, Class II
System, Multipurpose for in vitro
coagulation studies | Same |
| 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. | The STA R Max 3® and STA Compact
Max 3® are fully automatic clinical
analyzers designed to be used by
professional laboratory personnel and to
perform tests on human venous plasmas
(in 3.2% trisodium citrate tubes) the
results of which aid in the diagnosis of
coagulation abnormalities or in
monitoring anticoagulant therapy. |
| Anatomical Sites | In vitro testing of human plasma | Same |
| Sample Matrix | Human plasma
3.2% sodium citrate | Same |
| Where Used: hospital, home,
ambulance, etc. | Hospital Laboratory or other Health Care
Laboratory. | Same |
| Measurement Principle | Chronometric method (clotting time):
mechanical measurement of the
oscillation of the metal ball placed in the
cuvette
Photometric method: light absorption
technique provided by a filtered light
source | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be an abstract shape in red and brown, possibly representing a drop or a leaf.
| Attributes or Characteristics | Predicate Device STA Compact Max (K130090) | Candidate Device STA Compact Max 3 |
|---|---|---|
| (405nm, 540nm). | ||
| Cap Piercing | Available as an option | Available as an option with HIL pre- analytical module. |
| New needle connector, new cap piercing foot and evolution of the lock system. | ||
| Control of Fluidic System | Valcor pump and Hamilton syringes | PSR (Pipettor Simple Resolution) in replacement of Valcor pump and Hamilton syringes |
| Needles | One sample, Two reagent | One sample, Two reagent |
| Operating Environment Temperature | 59° - 89.5°F | Same |
| User/Patient Data Input | Touchscreen, keyboard, and/or barcode scanner | Same |
| Specimen Processing | Automatic pipetting and dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes | Same |
| Stat Testing | Yes | Same |
| Parameters | Prothrombin Time (PT) seconds, PT INR, Activated Partial Thromboplastin Time (APTT), Fibrinogen, Thrombin Time (TT), Reptilase, Extrinsic pathway factors, Intrinsic pathway factors, Anti-Xa (UFH, LMWH), Antithrombin (AT) activity, D-Dimer, Protein C activity, Protein S activity, Free Protein S antigen, Lupus anticoagulant, vWF antigen, Plasminogen | Same |
10
Image /page/10/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be two curved shapes, one red and one brown, arranged in a circular fashion. The overall design is simple and modern.
| Table 5: STA Compact Max 3 Differences Between Candidate and Predicate Devices | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------------------------- | -- | -- |
| Attributes or Characteristics | Predicate Device
STA Compact Max (K130090) | Candidate Device
STA Compact Max 3 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HIL Pre-analytical
Module | Not available | Avalable as an option: Semi quantitative
determination of hemolysis, icterus and
Lipemia (HIL) in patient plasma, reported
as indices according to CLSI C56-A
document. No predefined alerts are set-up
in the analyzer; users are responsible for
setting thresholds according to practices.
Any evaluation of indices as potential
interfering substances are left to the end
users. |
| Data Storage Capacity | 160 GB | 320 GB |
| Software | Windows XP | Windows 10 |
| Cybersecurity | In 2019, Stago implemented a new PC-
Gen with a new Windows 10 Operating
System (OS), updated software, and the
introduction of cybersecurity via internal
documentation agreed with FDA during
Q181507. | Introduced with user account management
(reinforced passwords, restrictive access,
log history...), firewall, antivirus, and
data encryption. |
Standards/Guidance Documents Referenced:
- . CLSI EP09c, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Method Comparison: STA R Max 3
Method comparison studies designed according to CLSI EP09c recommendations were conducted at three external sites.
Samples were selected in order to cover the entire measuring range of each assay and measured on both the predicate device (STA R Max) and subject device (STA R Max 3). Results were compared by either Passing & Bablok or Deming regression analysis based on the distribution. The following summary shows the results of this analysis without outliers across the analytical measuring range and targeted medical decision points per parameter.
STA R Max 3: STA - Neoplastine CI Plus Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman
(95% CI) |
|-----------|---------------------------|----------------------------|------------------------------|
| All Sites | 0.98
(0.97 to
0.98) | 0.20 sec
(0.06 to 0.30) | 0.997
(0.996 to
0.998) |
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Image /page/11/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a red, serif font. Above the word is an abstract graphic element that resembles a stylized, incomplete circle or crescent shape. The top portion of the shape is red, while the bottom portion is brown. The overall design is simple and modern.
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman
(95% CI) |
|-----------|---------------------------|--------------------------|---------------------------|
| All Sites | 1.00
(0.98 to
1.01) | -0.32
(-1.02 to 0.32) | 0.997 (0.996
to 0.998) |
STA R Max 3: STA - PTTA Passing-Bablok Regression Numerical Results
STA R Max 3: STA - Fibrinogen Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman (95% CI) |
|-----------|------------------------|-------------------------------|------------------------|
| All Sites | 1.01
(0.99 to 1.03) | 4.26 mg/dL
(-1.83 ; 10.14) | 0.996 (0.995 to 0.997) |
STA R Max 3: STA - Stachrom ATIII Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman
(95% CI) |
|-----------|------------------------|--------------------------|------------------------------|
| All Sites | 1.03
(1.00 to 1.07) | -1.03%
(-3.15 ; 2.00) | 0.980
(0.972 to
0.985) |
STA R Max 3: STA - Liatest D-DI Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman
(95% CI) |
|-----------|------------------------|-------------------------------|------------------------------|
| All Sites | 1.02
(1.01 to 1.03) | -0.02 µg/mL
(-0.04 ; 0,01) | 0.998
(0.998 to
0.999) |
Method Comparison: STA Compact Max 3
Method comparison studies designed according to CLSI EP09c recommendations were conducted at three external sites.
Samples were selected in order to cover the entire measuring range of each assay and measured on both the predicate device (STA Compact Max) and subject device (STA Compact Max 3). Results were compared by either Passing & Bablok or Deming regression analysis based on the distribution. The following summary shows the results of this analysis without outliers across the analytical measuring range and targeted medical decision points per parameter.
STA Compact Max 3: STA - Neoplastine CI Plus Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | r Spearman
(95% CI) |
|-----------|---------------------|-------------------------|-------------------------------|
| All Sites | 0.99 (0.98 to 1.00) | 0.20 sec (0.05 to 0.35) | 0.994 (0.993 to 0.996) |
STA Compact Max 3: STA - PTTA Passing-Bablok Regression Numerical Results
| Site | Slope (95% CI) | Intercept (95% CI) | rSpearman (95% CI) |
|---|---|---|---|
| All Sites | 0.99 (0.97 to 1.00) | 0.06 sec (-0.56 to 0.81) | 0.996 (0.995 to 0.997) |
STA Compact Max 3: STA - Fibrinogen Passing-Bablok Regression Numerical Results
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Image /page/12/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be an abstract representation of a drop or a leaf, with the top portion in red and the bottom portion in brown. The overall design is simple and modern.
| Site | Slope
(95% CI) | Intercept
(95% CI) | rSpearman
(95% CI) |
|-----------|------------------------|-------------------------------|---------------------------|
| All Sites | 1.01 (1.00
to 1.03) | 4.94 mg/dL
(0.67 to 11.25) | 0.995 (0.993
to 0.996) |
STA Compact Max 3: STA - Stachrom ATIII Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | r Spearman (95% CI) |
|-----------|---------------------|-----------------------|----------------------------|
| All Sites | 1.00 (1.00 to 1.03) | 0.00% (-1.63 to 0.00) | 0.981 (0.975 to 0.986) |
STA Compact Max 3: STA - Liatest D-DI Passing-Bablok Regression Numerical Results
| Site | Slope
(95% CI) | Intercept
(95% CI) | r Spearman
(95% CI) |
|-----------|---------------------|------------------------------|-------------------------------|
| All Sites | 1.02 (1.01 to 1.03) | -0.01 μg/mL (-0.04 to 0.01) | 0.997 (0.996 to 0.998) |
Method Comparison: HIL
The candidate instrument STA R Max 3 was compared to the reference methods, cobas® 8000 modular analyzer (Hemolyis, Icterus, and Lipemia) and spectrophotometer (Lipemia) in a method comparison study performed in accordance with CLSI EP09c guideline at one site.
| Hemolysis Passing-Bablok Regression | |||
|---|---|---|---|
| Analysis | Slope | ||
| (95% CI) | Intercept | ||
| (95% CI) | R | ||
| Spearman | |||
| (95% CI) | |||
| Hemolysis | |||
| With | |||
| Outliers | 1.12 (1.08 | ||
| to 1.19) | -0.03 g/L (-0.06 | ||
| to -0.01) | 0.954 | ||
| (0.916 to | |||
| 0.975) | |||
| Hemolysis | |||
| Without | |||
| Outliers | 1.11 (1.07 | ||
| to 1.14) | -0.03 g/L (-0.05 | ||
| to -0.01) | 0.948 | ||
| (0.904 to | |||
| 0.972) |
Hemolysis Passing-Rablok Regression
Icterus Passing-Bablok Regression
| Analysis | Slope
(95% CI) | Intercept
(95% CI) | R
Spearman
(95% CI) |
|----------|------------------------|------------------------------|------------------------------|
| Icterus | 0.99 (0.96
to 1.07) | 0.26 mg/dL
(0.02 to 0.48) | 0.956
(0.920 to
0.976) |
Lipemia Linear Regression versus Spectrophotometer
| Analysis | Regression coefficient (r) |
|---|---|
| Lipemia | 0.91 ; P |