The STA- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

Device Description

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains:
STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2
STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2
Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen.
Reagent 2 is a solvent containing calcium.
The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen).
The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used:
INR = ( Patient's PT / Mean Normal PT ) * ISI
The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called STA-NeoPTimal, which is a Prothrombin Time (PT) test. The document primarily focuses on the device's performance characteristics, stability, and comparison to a predicate device. It does not describe a study involving human readers or AI assistance. Therefore, I cannot extract information related to MRMC studies, the number of experts for ground truth, or the sample size of a training set for an AI model from this document.

However, I can provide information based on the performance criteria and studies detailed in the document for the STA-NeoPTimal device itself.

Here's the information extracted and organized as requested, with details that are present in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" values in a table for each performance characteristic but rather describes that "acceptance criteria were met for all samples in the studies." The tables provided show the reported device performance.

Table of Performance Characteristics (Reported Device Performance)

Performance Characteristic	Reported Device Performance
Precision/Reproducibility
Single-site Precision
STA R Max (seconds)	Total CV: 1.41% - 3.19% across 11 samples (mean PT: 13.861 - 70.665 seconds)
STA R Max (INR)	Total CV: 2.01% - 4.48% across 7 samples (mean INR: 1.0120 - 5.4507)
STA Compact Max (seconds)	Total CV: 1.80% - 5.09% across 11 samples (mean PT: 14.132 - 69.433 seconds)
STA Compact Max (INR)	Total CV: 2.56% - 6.87% across 7 samples (mean INR: 1.0321 - 5.3553)
STA Satellite (seconds)	Total CV: 2.00% - 3.82% across 11 samples (mean PT: 13.639 - 71.376 seconds)
STA Satellite (INR)	Total CV: 2.12% - 5.09% across 7 samples (mean INR: 1.0032 - 5.5795)
Multi-site Precision
STA R Max (seconds)	Total CV: 2.86% - 3.63% across 11 samples (mean PT: 14.272 - 71.215 seconds)
STA R Max (INR)	Total CV: 3.22% - 4.26% across 7 samples (mean INR: 1.0434 - 5.4936)
STA Compact Max (seconds)	Total CV: 2.81% - 5.16% across 11 samples (mean PT: 14.291 - 70.780 seconds)
STA Compact Max (INR)	Total CV: 3.35% - 6.41% across 7 samples (mean INR: 1.0444 - 5.4617)
STA Satellite (seconds)	Total CV: 2.76% - 5.93% across 11 samples (mean PT: 13.957 - 74.733 seconds)
STA Satellite (INR)	Total CV: 3.02% - 7.19% across 7 samples (mean INR: 1.0275 - 5.8552)
Extrinsic Factor Sensitivity	Percentage of factor (STA NeoPTimal): Factor II: 46%, Factor V: 59%, Factor VII: 55%, Factor X: 65%
Interferences	No interference up to: Triglycerides (3270 mg/dL), Hemoglobin (4000 mg/dL), Conjugated Bilirubin (29 mg/dL), Unconjugated Bilirubin (20 mg/dL), UFH (1.0 IU/mL), LMWH (1.5 IU Anti-Xa/mL), Apixaban (13 ng/mL), Dabigatran (3 ng/mL), Edoxaban (6 ng/mL), Rivaroxaban (7 ng/mL).
Stability
Sample Stability – Room Temp	Plasma stable for 24 hours at room temperature.
Sample Stability – Long-term Frozen	Plasma stable for 12 months at ≤ -70°C.
Shelf-life Stability	STA – NeoPTimal (5): 24 months at 2-8°C. STA – NeoPTimal (10): 24 months at 2-8°C.
In-Use Stability	STA-R family/STA Compact family: 48h on board for 5ml, 4 days on board for 10ml. STA Satellite family: 48h on board for 5ml, 4 days on board for 10ml. 2-8°C: 8 days for both.
Method Comparison
Slope	0.93 (95% CI: 0.92 to 0.95)
Intercept	0.04 (95% CI: 0.02 to 0.06)
rPearson	0.965
Bias at 2.5 INR	-5.3% (95% CI: -6.2% to -4.3%)
Bias at 3.5 INR	-5.7% (95% CI: -6.9% to -4.6%)
Reference Interval	11.8 to 14.9 seconds, and 0.89 to 1.11 INR for adults.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Precision/Reproducibility (Single-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=240 replicates (2 replicates/day over 20 days) on each of three instruments (STA R Max, STA Compact Max, STA Satellite). Data provenance is "one external site" for single-site testing.
Precision/Reproducibility (Multi-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=270 replicates (2 runs/day over 5 days at 3 sites per analyzer). Data provenance is "three external sites" per analyzer.
Extrinsic Factor Sensitivity: Not explicitly stated, but implies the use of contrived samples with known factor levels.
Interferences: Four samples were used: 1 normal, 2 VKA patient samples (INR 2.0-3.0 and 3.1-4.5), and 1 Deficient V patient sample.
Sample Stability (Room Temperature): Four normal samples and eight VKA samples (INR 1.5 to 5.5).
Sample Stability (Long-term Frozen): 53 samples stored at ≤ -70°C (Normal and VKA patient samples with INR between 1.5 and 5.0).
Shelf-life Stability: 10 samples (Normal, VKA patient samples with INR 2-4.5, Deficient V, Quality controls).
In-Use Stability: Six samples (Normal, VKA 2-3, VKA 3-4.5, Deficient V, Two controls).
Method Comparison: Not explicitly stated, but it was an "external method comparison study" involving "four sites" comparing STA NeoPTimal with Thromborel S.
Reference Interval: 137 patients. Data provenance is "across three external sites."

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but as performance validation studies for a device, they are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is an in-vitro diagnostic test for Prothrombin Time, and the "ground truth" (or reference values) is established through laboratory methods and reference standards, not expert interpretation of qualitative data like images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of in-vitro diagnostic device performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document describes a laboratory diagnostic device, not an AI-assisted diagnostic tool that would involve human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a standalone in-vitro diagnostic reagent kit used on automated instruments (STA-R family, STA Compact family, STA Satellite family). Its performance is evaluated directly (algorithm-like in terms of automated measurement) without direct human interpretation in the loop of the measurement itself, though human professionals use the results.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this in-vitro diagnostic device is established by:

Reference Intervals: Determined using a population of 137 patients according to CLSI guideline EP28-A3c.
Comparison to Predicate Device: Performance is compared to an existing, legally marketed predicate device (Thromborel® S) using a method comparison study.
Known Concentrations/Levels: For intrinsic validity testing like Extrinsic Factor Sensitivity and Interference studies, controlled samples with known concentrations of factors or interfering substances are used.
Standardized Prothrombin Time Measurement: The core measurement (PT) itself is a standardized laboratory test.

8. The sample size for the training set

Not applicable. This document describes a new in-vitro diagnostic reagent, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 23, 2022

Diagnostica Stago SAS % Anthony Dennis US Market Access Director Diagnostica Stago Inc. 5 Century Drive Parsippany, New Jersey 07054

Re: K211485

Trade/Device Name: STA - NeoPTimal Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 2, 2022 Received: September 6, 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

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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 shows the text "Min Wu-S" in a large, bold, sans-serif font. The text is black against a white background. The words are spaced apart, with a hyphen connecting "Wu" and "S". The text appears to be a name or title.

Min Wu 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

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Indications for Use

510(k) Number (if known)

K211485

Device Name STA - NeoPTimal

Indications for Use (Describe)

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 a red, serif font. Above the word "Stago" are two abstract shapes. The shape on the left is red, and the shape on the right is brown.

ട്. 510(k) SUMMARY

General Information
Submitter Information:	Diagnostica Stago, Inc.5 Century DriveParsippany, NJ 07054Primary Contact: Anthony Dennis, MBA, RAC, CBA (ASQ)Director, US Market AccessPhone: 1 – (973) – 775-1200 x4162On Behalf of: Diagnostica Stago SAS
Date of Submission:	12 May 2021; Revised 22 October 2022
Device Information
Device Trade Name:	STA® - NeoPTimal
Regulatory Information
Classification Name:	Test Time Prothrombin

Classification Name: Test, Time, Prothrombin Regulatory Class: Class II Panel: Hematology Product Code: Gla Regulation Number 21 CFR 864.7750 Predicate Device: Thromborel® S (K003870)

Device Intended Use

The STA®- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R® family, STA Compact® family and STA Satellite® family instruments. STA®- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

Device Description

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains:

Table 1 - Description of STA® – NeoPTimal Kits
STA® - NeoPTimal 5	STA® - NeoPTimal 10
6 x 5 ml vials of Reagent 1	12 x 10 ml vials of Reagent 1
6 x 5 ml vials of Reagent 2	12 x 10 ml vials of Reagent 2

Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen.

Reagent 2 is a solvent containing calcium.

The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen).

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Image /page/4/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 fashion.

The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used:

INR = ( Patient's PT / Mean Normal PT ) * ISI

The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

Attributes orcharacteristics	Dade Behring, Thromborel® S(Predicate device (K003870))	Diagnostica Stago, STA® - NeoPTimal(Subject device)
Indications for use	Thromborel S Reagent is used for thedetermination of the Prothrombin Time (PT)according to Quick and, in conjunction withthe relevant deficient plasmas, for thedetermination of the coagulation factor II,V, VII and X.	The STA®- NeoPTimal kits providethromboplastin reagents from rabbit brainextract, for the quantitative determination, inhuman citrated plasma (3.2% sodiumcitrate), of Prothrombin Time (PT) on STA-R® Family, STA Compact® Family andSTA Satellite® Family. STA®- NeoPTimalis a coagulation screening test intended to beused by professional laboratory personnelfor the evaluation of the extrinsiccoagulation pathway and the monitoring oforal vitamin K antagonist therapy using theInternational Normalized Ratio (INR).
Contents of the Kit	Reagent 1: Lyophilized thromboplastinextracted from human placentaReagent 2: solvent with calciumPackaging sizes:	Reagent 1: Lyophilized thromboplastinextracted from rabbit brainReagent 2: solvent with calciumPackaging sizes:
	4 mL10 mL	5 mL10 mL
Assay Method	Clotting Time	Same
Test Principle	The Thromborel® S test is a coagulationprocess triggered by incubation of plasmawith the optimal amount of thromboplastinand calcium. The time to formation of afibrin clot is then measured.	The STA® - NeoPTimal test consists of theuse of calcium thromboplastin to measurethe clotting time of the patient's plasma andto compare it with that of a normal standard.The test measures, as a whole, the activity othe coagulation factor II (prothrombin),factor V (proaccelerin), factor VII(proconvertin), factor X (Stuart factor) andfactor I (fibrinogen).
Anatomical Sites	Not applicable. No direct patient contact.	Same
Where Used: hospital,home, ambulance, etc.	Hospital Laboratory or other Health CareLaboratory.	Same
Sterility	No sterility requirements. No direct patientcontact	Same
Biocompatibility	No biocompatibility requirements. No directpatient contact.	Same
Attributes orcharacteristics	Dade Behring, Thromborel® S(Predicate device (K003870))	Diagnostica Stago, STA® - NeoPTimal(Subject device)
Chemical Safety	No issues regarding chemical safety due tono direct patient contact	Same
Analyzers	Sysmex® CA series and Siemens BCSseries	STA-R® Family, STA Compact® Familyand STA Satellite® Family

Substantial Equivalence

Table 2 – Comparison of the STA® - NeoPTimal to the Predicate Device

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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 in a way that suggests movement or flow. The overall design is simple and modern.

STA® - NeoPTimal is substantially equivalent to the predicate device, Thromborel® S (K003870) in indication/intended use, test principle, assay method and performance; thus yielding no new questions in safety and effectiveness.

Standards/Guidance Documents Referenced:

CLSI EP25-A - Evaluation of Stability of In Vitro Diagnostic Reagents. Approved Guideline
. CLSI EP09c, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
CLSI H47-A2, One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time . (APTT) Test, 2nd Edition
. CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline -Third Edition.
. CLSI H48-2ed, Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay -Second Edition
EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline
CLSI H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline
. EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - 3rd Edition

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Performance Characteristics

Precision/Reproducibility

Single-site precision testing was performed over 20 days at one external site on the STA Compact Max, and STA Satellite. 11 samples were tested across the measuring range, with two replicates per day. Each run was at least two hours apart. The acceptance criteria were met for all samples in the studies.

	STA R Max - All lots (seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	14.270	0.119	0.83	0.140	0.98	0.081	0.57	0.201	1.41	0.000	0.00	0.201	1.41
2	240	13.861	0.126	0.91	0.132	0.95	0.104	0.75	0.210	1.52	0.000	0.00	0.210	1.52
3	240	30.888	0.341	1.10	0.700	2.27	0.309	1.00	0.838	2.71	0.248	0.80	0.874	2.83
4	240	45.502	0.416	0.91	0.951	2.09	0.000	0.00	1.038	2.28	0.364	0.80	1.100	2.42
5	240	62.892	0.527	0.84	1.413	2.25	0.517	0.82	1.594	2.53	0.471	0.75	1.662	2.64
6	240	70.665	0.783	1.11	2.062	2.92	0.000	0.00	2.206	3.12	0.456	0.65	2.253	3.19
7	240	26.270	0.339	1.29	0.520	1.98	0.000	0.00	0.621	2.36	0.190	0.72	0.649	2.47
8	240	14.831	0.138	0.93	0.138	0.93	0.052	0.35	0.202	1.36	0.028	0.19	0.204	1.38
9	240	26.111	0.256	0.98	0.656	2.51	0.108	0.41	0.712	2.73	0.000	0.00	0.712	2.73
10	240	14.908	0.125	0.84	0.184	1.23	0.000	0.00	0.222	1.49	0.000	0.00	0.223	1.50
11	240	38.953	0.307	0.79	1.056	2.71	0.000	0.00	1.100	2.82	0.000	0.00	1.100	2.82

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STA R Max - All lots (INR)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	1.0422	0.010	0.96	0.010	0.96	0.006	0.58	0.015	1.47	0.014	1.34	0.021	2.01
2	240	1.0120	0.009	0.89	0.010	0.99	0.007	0.69	0.015	1.50	0.015	1.48	0.021	2.08
3	240	2.3171	0.027	1.17	0.054	2.33	0.023	0.99	0.065	2.79	0.050	2.16	0.082	3.54
4	240	3.4577	0.032	0.93	0.075	2.17	0.000	0.00	0.082	2.36	0.095	2.75	0.125	3.62
5	240	4.8318	0.042	0.87	0.114	2.36	0.040	0.83	0.128	2.65	0.151	3.13	0.198	4.10
6	240	5.4507	0.062	1.14	0.164	3.01	0.000	0.00	0.175	3.22	0.170	3.12	0.244	4.48
10	240	1.0913	0.010	0.92	0.014	1.28	0.000	0.00	0.017	1.58	0.016	1.47	0.024	2.20

STA Compact Max - All lots(seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	14.401	0.191	1.33	0.159	1.10	0.075	0.52	0.260	1.80	0.000	0.00	0.259	1.80
2	240	14.132	0.209	1.48	0.246	1.74	0.142	1.00	0.353	2.50	0.000	0.00	0.353	2.50
3	240	29.531	0.589	1.99	1.053	3.57	0.000	0.00	1.207	4.09	0.136	0.46	1.214	4.11
4	240	44.070	0.870	1.97	1.635	3.71	0.000	0.00	1.852	4.20	0.478	1.08	1.913	4.34
5	240	61.342	0.974	1.59	2.791	4.55	0.000	0.00	2.956	4.82	0.474	0.77	2.994	4.88
6	240	69.433	1.444	2.08	3.209	4.62	0.000	0.00	3.519	5.07	0.289	0.42	3.531	5.09
7	240	25.510	0.420	1.65	0.924	3.62	0.000	0.00	1.015	3.98	0.177	0.69	1.030	4.04
8	240	14.865	0.236	1.59	0.203	1.37	0.091	0.61	0.324	2.18	0.000	0.00	0.324	2.18
9	240	25.030	0.402	1.61	0.890	3.56	0.000	0.00	0.977	3.90	0.196	0.78	0.996	3.98
10	240	14.929	0.263	1.76	0.139	0.93	0.148	0.99	0.332	2.23	0.000	0.00	0.332	2.22
11	240	37.850	0.625	1.65	1.188	3.14	0.000	0.00	1.342	3.55	0.408	1.08	1.403	3.71

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Image /page/8/Picture/0 description: The image contains the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word, there is an abstract graphic consisting of two curved shapes, one red and one brown, arranged in a circular pattern.

STA Compact Max - Alllots (INR)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	1.0527	0.014	1.33	0.012	1.14	0.006	0.57	0.019	1.84	0.018	1.71	0.027	2.56
2	240	1.0321	0.016	1.55	0.019	1.84	0.010	0.97	0.027	2.59	0.016	1.55	0.032	3.10
3	240	2.2125	0.046	2.08	0.082	3.71	0.000	0.00	0.094	4.25	0.067	3.03	0.115	5.20
4	240	3.3475	0.067	2.00	0.129	3.85	0.000	0.00	0.145	4.34	0.144	4.30	0.204	6.09
5	240	4.7113	0.078	1.66	0.222	4.71	0.000	0.00	0.235	4.99	0.204	4.33	0.312	6.62
6	240	5.3553	0.115	2.15	0.257	4.80	0.000	0.00	0.282	5.26	0.237	4.43	0.368	6.87
10	240	1.0925	0.020	1.83	0.011	1.01	0.011	1.01	0.025	2.32	0.019	1.74	0.032	2.93

STA Satellite - All lots(seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	14.108	0.139	0.99	0.218	1.55	0.000	0.00	0.259	1.83	0.112	0.79	0.282	2.00
2	240	13.639	0.165	1.21	0.202	1.48	0.000	0.00	0.261	1.91	0.136	1.00	0.294	2.16
3	240	29.791	0.439	1.47	0.731	2.45	0.000	0.00	0.853	2.86	0.000	0.00	0.853	2.86
4	240	44.366	0.695	1.57	0.983	2.22	0.313	0.71	1.244	2.80	0.563	1.27	1.366	3.08
5	240	64.173	0.688	1.07	2.063	3.21	0.227	0.35	2.187	3.41	0.666	1.04	2.286	3.56
6	240	71.376	1.334	1.87	2.307	3.23	0.000	0.00	2.665	3.73	0.590	0.83	2.730	3.82
7	240	24.988	0.267	1.07	0.505	2.02	0.000	0.00	0.571	2.29	0.000	0.00	0.571	2.29
8	240	14.557	0.221	1.52	0.242	1.66	0.081	0.56	0.338	2.32	0.025	0.17	0.339	2.33
9	240	25.170	0.345	1.37	0.709	2.82	0.000	0.00	0.788	3.13	0.000	0.00	0.789	3.13
10	240	14.665	0.140	0.95	0.172	1.17	0.070	0.48	0.233	1.59	0.074	0.50	0.244	1.66
11	240	38.025	0.559	1.47	1.211	3.18	0.000	0.00	1.334	3.51	0.266	0.70	1.360	3.58

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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 two curved shapes, one red and one brown, arranged in a way that suggests movement or flow. The overall design is simple and modern.

STA Satellite - All lots(INR)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	240	1.0383	0.011	1.06	0.016	1.54	0.000	0.00	0.019	1.87	0.009	0.87	0.022	2.12
2	240	1.0032	0.013	1.30	0.016	1.59	0.000	0.00	0.021	2.05	0.009	0.90	0.022	2.19
3	240	2.2549	0.034	1.51	0.057	2.53	0.000	0.00	0.066	2.94	0.042	1.86	0.079	3.50
4	240	3.4083	0.055	1.61	0.080	2.35	0.026	0.76	0.101	2.95	0.103	3.02	0.144	4.22
5	240	4.9968	0.055	1.10	0.166	3.32	0.014	0.28	0.175	3.51	0.163	3.26	0.240	4.80
6	240	5.5795	0.108	1.94	0.190	3.41	0.000	0.00	0.219	3.92	0.181	3.24	0.284	5.09
10	240	1.0812	0.012	1.11	0.013	1.20	0.006	0.55	0.019	1.73	0.013	1.20	0.022	2.03

Multi-site precision testing was performed over five days at three external sites per analyzer (STA R Max, STA Compact Max, and STA Satellite). 11 samples were tested across the measuring range, with two runs per day. Each run was at least two hours apart. The acceptance criteria were met for all samples in the studies.

STA R Max - All sites - Alllots(seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	14.662	0.139	0.95	0.153	1.04	0.000	0.00	0.207	1.41	0.016	0.11	0.396	2.70	0.447	3.05
2	270	14.272	0.137	0.96	0.142	0.99	0.000	0.00	0.197	1.38	0.005	0.04	0.420	2.94	0.464	3.25
3	270	31.279	0.298	0.95	0.584	1.87	0.000	0.00	0.656	2.10	0.242	0.77	0.837	2.68	1.090	3.48
4	270	46.034	0.358	0.78	0.905	1.97	0.000	0.00	0.973	2.11	0.359	0.78	0.999	2.17	1.440	3.13
5	270	63.011	0.505	0.80	1.251	1.99	0.000	0.00	1.349	2.14	0.753	1.20	1.288	2.04	2.011	3.19
6	270	71.215	0.727	1.02	1.393	1.96	0.000	0.00	1.571	2.21	0.796	1.12	1.895	2.66	2.587	3.63
7	270	26.671	0.241	0.90	0.508	1.90	0.000	0.00	0.562	2.11	0.244	0.91	0.605	2.27	0.861	3.23
8	270	15.267	0.159	1.04	0.192	1.26	0.000	0.00	0.249	1.63	0.000	0.00	0.358	2.34	0.436	2.86
9	270	26.298	0.235	0.89	0.503	1.91	0.000	0.00	0.555	2.11	0.181	0.69	0.435	1.65	0.728	2.77
10	270	15.269	0.174	1.14	0.138	0.90	0.000	0.00	0.222	1.45	0.040	0.26	0.384	2.51	0.446	2.92
11	270	39.033	0.335	0.86	1.007	2.58	0.000	0.00	1.061	2.72	0.219	0.56	0.672	1.72	1.275	3.27

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization.

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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 way that suggests a stylized letter or symbol. The overall design is simple and modern.

STA R Max - All sites - Alllots(INR)	N	Mean	Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	1.0724	0.010	0.93	0.012	1.12	0.000	0.00	0.016	1.46	0.016	1.49	0.029	2.70	0.036	3.36
2	270	1.0434	0.010	0.96	0.012	1.15	0.000	0.00	0.016	1.50	0.016	1.53	0.030	2.88	0.037	3.55
3	270	2.3474	0.023	0.98	0.046	1.96	0.000	0.00	0.051	2.19	0.048	2.04	0.059	2.51	0.092	3.92
4	270	3.5000	0.028	0.80	0.072	2.06	0.000	0.00	0.077	2.21	0.086	2.46	0.063	1.80	0.132	3.77
5	270	4.8404	0.041	0.85	0.100	2.07	0.000	0.00	0.108	2.23	0.116	2.40	0.084	1.74	0.180	3.72
6	270	5.4936	0.057	1.04	0.112	2.04	0.000	0.00	0.126	2.29	0.149	2.71	0.129	2.35	0.234	4.26
10	270	1.1189	0.013	1.16	0.011	0.98	0.000	0.00	0.017	1.52	0.015	1.34	0.028	2.50	0.036	3.22

STA Compact Max - Allsites - All lots(seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	14.622	0.182	1.24	0.186	1.27	0.094	0.64	0.277	1.89	0.126	0.86	0.276	1.89	0.411	2.81
2	270	14.291	0.182	1.27	0.242	1.69	0.000	0.00	0.303	2.12	0.138	0.97	0.171	1.20	0.374	2.62
3	270	30.786	0.604	1.96	0.645	2.10	0.107	0.35	0.890	2.89	0.294	0.95	1.283	4.17	1.589	5.16
4	270	45.475	0.627	1.38	1.098	2.41	0.414	0.91	1.330	2.93	0.292	0.64	1.241	2.73	1.843	4.05
5	270	62.711	0.917	1.46	1.773	2.83	0.582	0.93	2.079	3.32	0.000	0.00	1.665	2.66	2.664	4.25
6	270	70.780	1.379	1.95	2.379	3.36	0.000	0.00	2.750	3.88	0.621	0.88	2.317	3.27	3.649	5.16
7	270	26.370	0.411	1.56	0.563	2.14	0.000	0.00	0.697	2.64	0.500	1.90	0.850	3.22	1.207	4.58
8	270	15.233	0.182	1.19	0.237	1.56	0.000	0.00	0.299	1.96	0.113	0.74	0.323	2.12	0.454	2.98
9	270	26.111	0.436	1.67	0.558	2.14	0.000	0.00	0.708	2.71	0.229	0.88	0.902	3.45	1.170	4.48
10	270	15.190	0.174	1.15	0.266	1.75	0.000	0.00	0.318	2.09	0.103	0.68	0.248	1.63	0.416	2.74
11	270	39.131	0.544	1.39	0.926	2.37	0.000	0.00	1.074	2.74	0.381	0.97	1.199	3.06	1.654	4.23

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Image /page/11/Picture/0 description: The image contains the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word, there is an abstract graphic consisting of two curved shapes, one red and one brown, arranged in a circular fashion.

STA Compact Max - Allsites - All lots(INR)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	1.0695	0.014	1.31	0.014	1.31	0.008	0.75	0.021	2.00	0.026	2.43	0.016	1.50	0.038	3.55
2	270	1.0444	0.014	1.34	0.018	1.72	0.000	0.00	0.023	2.18	0.027	2.59	0.000	0.00	0.035	3.35
3	270	2.3103	0.046	1.99	0.050	2.16	0.007	0.30	0.068	2.96	0.085	3.68	0.088	3.81	0.140	6.06
4	270	3.4573	0.050	1.45	0.087	2.52	0.030	0.87	0.105	3.03	0.139	4.02	0.057	1.65	0.183	5.29
5	270	4.8191	0.073	1.51	0.143	2.97	0.043	0.89	0.166	3.45	0.189	3.92	0.074	1.54	0.262	5.44
ଚି	270	5.4617	0.111	2.03	0.193	3.53	0.000	0.00	0.223	4.08	0.236	4.32	0.131	2.40	0.350	6.41
10	270	1.1126	0.014	1.26	0.021	1.89	0.000	0.00	0.025	2.27	0.026	2.34	0.013	1.17	0.038	3.42

STA Satellite - All sites -All lots(seconds)		Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	14.370	0.166	1.16	0.203	1.41	0.000	0.00	0.262	1.82	0.196	1.36	0.225	1.57	0.397	2.76
2	270	13.957	0.130	0.93	0.216	1.55	0.000	0.00	0.252	1.81	0.200	1.43	0.223	1.60	0.392	2.81
3	270	31.016	0.510	1.64	1.039	3.35	0.000	0.00	1.157	3.73	0.534	1.72	1.251	4.03	1.786	5.76
4	270	46.346	0.600	1.29	1.110	2.40	0.000	0.00	1.262	2.72	0.744	1.61	1.484	3.20	2.085	4.50
5	270	66.456	0.829	1.25	1.457	2.19	0.212	0.32	1.690	2.54	0.836	1.26	1.893	2.85	2.672	4.02
6	270	74.733	1.331	1.78	2.262	3.03	0.000	0.00	2.625	3.51	1.455	1.95	3.260	4.36	4.432	5.93
7	270	25.763	0.387	1.50	0.532	2.06	0.000	0.00	0.658	2.55	0.180	0.70	0.776	3.01	1.033	4.01
8	270	14.878	0.220	1.48	0.241	1.62	0.000	0.00	0.326	2.19	0.229	1.54	0.385	2.59	0.554	3.72
9	270	25.845	0.372	1.44	0.573	2.22	0.000	0.00	0.683	2.64	0.375	1.45	0.741	2.87	1.075	4.16
10	270	14.926	0.154	1.03	0.229	1.53	0.000	0.00	0.276	1.85	0.180	1.21	0.309	2.07	0.452	3.03
11	270	39.160	0.618	1.58	1.013	2.59	0.000	0.00	1.187	3.03	0.848	2.17	1.130	2.89	1.845	4.71

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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 three curved shapes, one red and one brown, arranged in a circular pattern.

STA Satellite - All sites -All lots(INR)			Repeatability		Between-run		Between-day		Within-lab		Between_lot		Between_site		Total
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
1	270	1.0587	0.012	1.13	0.016	1.51	0.000	0.00	0.020	1.89	0.020	1.89	0.015	1.42	0.032	3.02
2	270	1.0275	0.010	0.97	0.016	1.56	0.000	0.00	0.019	1.84	0.020	1.95	0.015	1.46	0.032	3.11
3	270	2.3522	0.039	1.66	0.082	3.49	0.000	0.00	0.091	3.86	0.088	3.74	0.088	3.74	0.154	6.55
4	270	3.5671	0.048	1.35	0.088	2.47	0.000	0.00	0.100	2.81	0.145	4.06	0.091	2.55	0.198	5.55
5	270	5.1826	0.068	1.31	0.117	2.26	0.014	0.27	0.136	2.63	0.204	3.94	0.105	2.03	0.267	5.15
6	270	5.8552	0.108	1.84	0.183	3.13	0.000	0.00	0.212	3.63	0.293	5.00	0.215	3.67	0.421	7.19
10	270	1.1012	0.012	1.09	0.018	1.63	0.000	0.00	0.022	1.96	0.023	2.09	0.021	1.91	0.038	3.45

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Image /page/13/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 way that suggests movement or flow. The overall design is simple and modern.

Analytical Specificity/Interference

Extrinsic Factor Sensitivity

The study was performed to determine at which clinically significant abnormal extrinsic factor levels (Factor II, V, VII and X) the STA® - NeoPTimal gives abnormal results for PT. The study was performed using three lots on the STA-R family of analyzers.

	STA NeoPTimal
Factor II	46 %
Factor V	59 %
Factor VII	55 %
Factor X	65 %

Interferences

This study was performed to evaluate the effect of (endogenous or exogenous) potentially interfering substances in the STA - NeoPTimal assay on four samples;

Patient sample included in the normal reference range
VKA patient sample with an INR between 2.0 and 3.0
VKA patient sample with an INR between 3.1 and 4.5 ●
Deficient V patient sample

Molecule	No interference up to
Triglycerides	3270 mg/dL
Hemoglobin	4000 mg/dL
Conjugated Bilirubin	29 mg/dL
Unconjugated Bilirubin	20 mg/dL
UFH	1.0 IU/mL
LMWH	1.5 IU Anti-Xa/mL
Apixaban	13 ng/mL
Dabigatran	3 ng/mL
Edoxaban	6 ng/mL
Rivaroxaban	7 ng/mL

Daptomycin

Note: According to the drug manufacturer, Daptomycin may artificially prolong PT and INR in patients with normal renal function for up to nine hours and for patients with renal impairment up to 28 hours'. Therefore, PT or INR monitoring of patients on Daptomycin may be affected for up to 28 hours after dosing.

Stability

Sample Stability – Room Temperature

A study of sample stability at room temperature was performed to demonstrate plasma remains stable for 24 hours if stored at room temperature. Four normal samples and eight VKA samples with INR between 1.5 to 5.5 were used along with one lot of STA NeoPTimal. Samples were testing in triplicate for each sample across different time points. All results met the acceptance criteria and support a plasma stability claim of 24 hours at room temperature.

1 PATEL S., SAW S. Daptomycin. [Updated 2020 Apr 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470407

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Image /page/14/Picture/0 description: The image contains the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word "Stago" is an abstract graphic consisting of two curved shapes, one red and one brown, arranged in a circular fashion. The red shape is positioned above the brown shape.

Sample Stability - Long-term Frozen

The study was performed across two lots of STA® - NeoPTimal on a STA-R family analyzer. Testing was performed on 53 samples stored at ≤ -70°C;

-Patient samples included in the normal reference range (Normal)
VKA patient samples with INR between 1.5 and 5.0 -

All samples were tested in triplicate at different time points. All results met the acceptance criteria and support a long-term frozen plasma stability claim of 12 months at ≤ -70℃.

Shelf-life Stability

The study was performed on three lots of each STA® - NeoPTimal configuration on a STA-R family analyzer. Testing was performed on 10 samples;

Patient samples included in the normal reference range (Normal) -
-VKA patient samples with INR between 2 and 4.5
Deficient V patient samples -
Quality controls -

All samples were tested in triplicate at different time points. The results support the following shelf-life when stored at 2-8°C:

Product	Shelf-Life Stability Claim
STA – NeoPTimal (5)	24 months
STA – NeoPTimal (10)	24 months

In-Use Stability

The study was performed on three lots of STA - NeoPTimal representing the two different volume configurations (5ml and 10ml) on the STA-R family, STA Compact family and STA Satellite instrumentation. Testing was performed on six samples:

Patient sample included in the normal reference range (Normal) .
VKA patient sample with an INR between 2.0 and 3.0 (VKA 2-3) .
VKA patient sample with an INR between 3.1 and 4.5 (VKA 3-4.5) .
. Deficient patient sample (Def V)
Two controls .

All the samples were tested after reconstitution (TOh) in triplicate at different time points. The result support the following:

	STA® - NeoPTimal 5	STA® - NeoPTimal 10
STA-R® familySTA Compact® family	48h on board
STA Satellite® family		4 days on board
2-8 °C	8 days

Detection Limit Not applicable

Assay Cut-off Not applicable

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Image /page/15/Picture/0 description: The image contains the logo for Stago. The logo features the word "Stago" in red, serif font. Above the word is an abstract graphic consisting of two curved shapes. The top shape is red, and the bottom shape is brown. The shapes are arranged in a way that suggests movement or rotation.

Comparison Studies

Method Comparison

Four sites were involved in the external method comparison study for STA – NeoPTimal to validate the performance of the STA - NeoPTimal kit via method comparison with the predicate device, Thromborel S across one STA R Max, STA Satellite, STA Compact Max, and three Siemens CA-1500s. The STA NeoPTimal performed comparably to the Thromborel S. All acceptance criteria were met.

Slope(95% CI)	Intercept(95% CI)	rPearson
0.93(0.92 to 0.95)	0.04(0.02 to 0.06)	0.965

Bias at 2.5 INR(95% CI)	Bias at 3.5 INR(95% CI)
-5.3%	-5.7%
(-6.2% to -4.3%)	(-6.9% to -4.6%)

Clinical Studies

Clinical Sensitivity Not applicable

Clinical Specificity Not applicable

Clinical Cut-off Not applicable

Reference Interval

The adult reference interval was based on calculations established within CLSI guideline EP28-A3c using 137 patients across three external sites. The reference interval for STA® -NeoPTimal was determined to be 11.8 to 14.9 seconds, and 0.89 to 1.11 INR.

CONCLUSION

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).