(299 days)
No
The summary describes a reagent and its performance characteristics for a standard coagulation test, with no mention of AI or ML.
No
This device is an in vitro diagnostic reagent used for quantitative determination of Prothrombin Time and Fibrinogen, which are diagnostic measurements and do not directly treat or prevent a disease.
Yes
This device is explicitly stated as an "in vitro diagnostic thromboplastin reagent" in the "Intended Use / Indications for Use" section. It is used for the quantitative determination of Prothrombin Time (PT) and Fibrinogen in human plasma, which are diagnostic tests for coagulation pathways and monitoring therapy.
No
The device is a reagent kit, which is a physical chemical substance used in a diagnostic test, not a software-only device. The description clearly details the chemical composition and how it interacts with plasma.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section:
"HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent..."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Product codes (comma separated list FDA assigned to the subject device)
GJS, GIS
Device Description
The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and stability studies were performed to establish the safety and effectiveness of the reformulated HemosIL ReadiPlasTin. These studies included repeatability, fibrinogen linearity, conjugated bilirubin and daptomycin interference, method comparison, open vial and on-board instrument stability and real-time shelf-life stability.
Precision:
Repeatability and within laboratory precision was assessed in accordance with CLSI EP05-A3 for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/instrument/lot), using 3 lots of HemosIL ReadiPlasTin on representative members of the ACL TOP Family and ACL TOP Family 50 Series. For PT, controls, as well as six native (unadulterated) patient samples, were tested; for fibrinogen, controls, as well as six fibrinogen sample pools at three levels, were tested.
Fibrinogen Linearity:
Fibrinogen linearity was assessed in accordance with CLSI EP06, 2nd Ed, using 3 lots of HemosIL ReadiPlasTin on representative members of the ACL TOP Family and ACL TOP Family 50 Series. The results for all 3 lots on both systems met acceptance criteria, supporting the labeled fibrinogen linearity claim of 60 to 700 mg/dL.
Interference:
Interference was assessed for conjugated bilirubin and daptomycin in accordance with CLSI EP07, 3d Ed, and CLSI EP37, 1st Ed, using 1 lot of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. The studies used two clinical sample levels each for PT (normal pooled plasma and a high INR clinical sample at 2.0-3.0 INR) and fibrinogen (normal pooled plasma and a low fibrinogen sample at ~100 mg/dL).
The results from these additional studies, along with the original interference studies under K122584, support the labeled claims of no interference for UFH (1.0 IU/mL for PT, 1.5 IU/mL for Fibrinogen), LMWH (1.4 IU/mL for PT, 1.7 IU/mL for Fibrinogen), Hemoglobin (500 mg/dL for PT and Fibrinogen), Triglycerides (1000 mg/dL for PT, 600 mg/dL for Fibrinogen), Bilirubin (Conjugated and Unconjugated) (50 mg/dL for PT and Fibrinogen), and Daptomycin (100 µg/mL for PT, 200 µg/mL for Fibrinogen).
Method Comparison:
In-house method comparison was performed in accordance with CLSI EP09c on normal and abnormal samples, comparing HemosIL ReadiPlasTin to HemosIL RecombiPlasTin 2G on a representative member of the ACL TOP Family and a representative member of the ACL TOP Family 50 Series.
Results:
ACL TOP Family:
PT (INR): n=160, Slope=1.031 (1.009, 1.053), Intercept=-0.043 (-0.068, -0.018), r=0.997
PT (INR): n=51, Slope=1.042 (1.006, 1.078), Intercept=0.011 (-0.072, 0.094), r=0.998
Fibrinogen (mg/dL): n=135, Slope=0.975 (0.963, 0.986), Intercept=7.171 (3.842, 10.50), r=0.995
ACL TOP Family 50 Series:
PT (INR): n=160, Slope=1.021 (0.999, 1.043), Intercept=-0.034 (-0.060, -0.009), r=0.996
PT (INR): n=51, Slope=1.029 (0.992, 1.067), Intercept=0.023 (-0.061, 0.107), r=0.997
Fibrinogen (mg/dL): n=134, Slope=1.015 (1.003, 1.027), Intercept=-0.811 (-4.148, 2.527), r=0.994
Open Vial Stability:
Open vial stability was assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples, were tested in eight replicates at each time interval to a point past claim; for fibrinogen, controls and six fibrinogen sample pools at three levels, were tested in eight replicates at each time interval to a point past claim.
Results support 10 days at 2-8°C in closed original vial once prepared for use.
On-board Instrument Stability:
On-board instrument stability was assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples, were tested in eight replicates at each time interval to a point past claim; for fibrinogen, controls and six fibrinogen sample pools at three levels, were tested in eight replicates at each time interval to a point past claim.
Results support 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series once prepared for use.
Real-time Shelf-life Stability:
Real-time shelf-life stability continues to be assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples were tested in eight replicates at Time 0 and this testing continues at each predefined time interval; for fibrinogen sample pools at three levels, were tested in eight replicates at Time 0 and this testing continues at each predefined time interval. The study will continue to a point past final claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (CV%):
ACL TOP Family PT: Normal Control (Repeatability CV 0.9%, Within Laboratory CV 1.1%), Low Abnormal Control (Repeatability CV 1.0%, Within Laboratory CV 1.3%), High Abnormal Control (Repeatability CV 0.6%, Within Laboratory CV 0.8%). Sample 1 (INR 1.81, Repeatability CV 1.0%, Within Laboratory CV 1.2%).
ACL TOP Family 50 Series PT: Normal Control (Repeatability CV 0.7%, Within Laboratory CV 1.0%), Low Abnormal Control (Repeatability CV 0.8%, Within Laboratory CV 0.9%), High Abnormal Control (Repeatability CV 1.0%, Within Laboratory CV 1.0%). Sample 1 (INR 1.79, Repeatability CV 0.8%, Within Laboratory CV 1.1%).
ACL TOP Family Fibrinogen: Normal Control (Mean 329 mg/dL, Repeatability CV 1.1%, Within Laboratory CV 1.2%), Low Abnormal Control (Mean 171 mg/dL, Repeatability CV 1.2%, Within Laboratory CV 1.5%), Low Fibrinogen Control (Mean 130 mg/dL, Repeatability CV 1.8%, Within Laboratory CV 2.0%).
ACL TOP Family 50 Series Fibrinogen: Normal Control (Mean 319 mg/dL, Repeatability CV 1.3%, Within Laboratory CV 1.4%), Low Abnormal Control (Mean 157 mg/dL, Repeatability CV 1.0%, Within Laboratory CV 1.4%), Low Fibrinogen Control (Mean 122 mg/dL, Repeatability CV 2.0%, Within Laboratory CV 2.3%).
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.
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
§ 864.7750 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).
0
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.
August 16, 2022
Instrumentation Laboratory Co. Carol Marble Sr. Regulatory Affairs Director 180 Hartwell Road Bedford, Massachusetts 01730
Re: K213426
Trade/Device Name: HemosIL ReadiPlasTin Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: October 20, 2021 Received: October 21, 2021
Dear Carol Marble:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
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
2
Indications for Use
510(k) Number (if known) K213426
Device Name HemosIL ReadiPlasTin
Indications for Use (Describe)
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist 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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3
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory Company
180 Hartwell Road
Bedford, MA 01730-2443 (USA) |
| ------------------------- | ----------------------------------------------------------------------------------------- |
|---|
| Contact Person | Carol Marble
Senior Director of Quality Assurance and Regulatory Affairs
Phone: 781-861-4467
Fax: 781-861-4207
Email: cmarble@werfen.com |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Preparation Date | August 16, 2022 |
|---|---|
| ------------------ | ----------------- |
| Predicate Device | HemosIL ReadiPlasTin | K122584 |
|---|---|---|
| ------------------ | ---------------------- | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | Panel | ||||
| Prothrombin Time | 864.7750 | Prothrombin time test | II | GJS | 81 |
| Fibrinogen | 864.7340 | Fibrinogen determination system | II | GIS |
4
Device Description
The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.
Intended Use / Indications for Use
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Reason for Submission
This Traditional 510(k) is being submitted to reformulate HemosIL ReadiPlasTin, adding EDTA as a stabilizer to improve reagent stability and also removing unnecessary fillers used to make acceptable appearing cakes after lyophilization. These filler ingredients are a carryover from a previous generation of lyophilized reagents. Since HemosIL ReadiPlasTin kit components are liquid, these filler ingredients serve no intended purpose.
There were no changes to the following with this submission:
- Intended use/indications for use .
- Operating principle .
- Labeled performance characteristics, except for the addition of daptomycin interference claims ●
5
| Summary Comparison of Technological Characteristics (Predicate) | ||
|---|---|---|
| Item | Predicate (K122584) | Subject Device |
| Similarities | ||
| Trade Name | HemosIL ReadiPlasTin | Same |
| Manufacturer | Instrumentation Laboratory Company | Same |
| Intended Use/ | ||
| Indications for Use | HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. | Same |
| Test Principle | Prothrombin Time (PT): In the PT test, the addition of the tissue thromboplastin to the patient plasma, in the presence of calcium, initiates the activation of the extrinsic pathway. This results in the conversion of fibrinogen to fibrin, with the formation of a solid gel. |
PT-derived Fibrinogen: Fibrinogen is quantitated (PT-based method) by relating the absorbance or light scatter during clotting to a calibrator. | Same |
| Sample Type | 3.2% and 3.8% Citrated Plasma | Same |
| Measurement | Quantitative | Same |
| Reporting Units | PT: Seconds, % Activity, INR
Fibrinogen: mg/dL, g/L | PT: Seconds, INR
Fibrinogen: mg/dL, g/L |
| Summary Comparison of Technological Characteristics (Predicate) (Cont.) | | |
| Item | Predicate (K122584) | Subject Device |
| Similarities (Cont.) | | |
| Instrumentation | ACL TOP Family K160276
ACL TOP Family 50 Series K150877 | Same |
| Quality Control | Automated QC | Same |
| Vial Content | Liquid | Same |
| On-Board Stability | 10 days at 15°C on the instrument | Same |
| Open Vial Stability | 10 days at 2-8°C in closed original vial | Same |
| Differences | | |
| Formulation | Each ReadiPlasTin kit consists of:
ReadiPlasTin Reagent: A solution of recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer
ReadiPlasTin Diluent: An aqueous solution of calcium chloride, polybrene and a preservative. | Same except the following formulation changes:
- Addition of EDTA to ReadiPlasTin Reagent as a stabilizer for improved stability.
- Removal of bovine gamma globulin (BGG) and trehalose from ReadiPlasTin Reagent and trehalose from ReadiPlasTin Diluent as inactive ingredients (fillers) with no intended purpose in liquid reagents. These ingredients are a carryover from a previous generation of lyophilized reagents. |
6
7
Performance and Stability Studies
Performance and stability studies were performed to establish the safety and effectiveness of the reformulated HemosIL ReadiPlasTin. These studies included repeatability, fibrinogen linearity, conjugated bilirubin and daptomycin interference, method comparison, open vial and on-board instrument stability and real-time shelf-life stability.
The testing below and on the following pages met all acceptance criteria as follows.
Precision
Repeatability and within laboratory precision was assessed in accordance with CLSI EP05-A3 for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/instrument/lot), using 3 lots of HemosIL ReadiPlasTin on representative members of the ACL TOP Family and ACL TOP Family 50 Series.8 For PT, controls, as well as six native (unadulterated) patient samples, were tested; for fibrinogen, controls, as well as six fibrinogen sample pools at three levels, were tested.
The following tables include PT seconds, INR and fibrinogen precision data for representative systems each with one reagent lot.
| Prothrombin Time (PT) Precision | ||||
|---|---|---|---|---|
| System | Sample | Mean PT | ||
| (Seconds) | Repeatability | |||
| CV | Within | |||
| Laboratory CV | ||||
| ACL TOP Family | Normal Control | 11.4 | 0.9% | 1.1% |
| Low Abnormal Control | 22.5 | 1.0% | 1.3% | |
| High Abnormal Control | 37.5 | 0.6% | 0.8% | |
| Sample 1 | 20.8 | 0.8% | 1.1% | |
| Sample 2 | 31.4 | 0.9% | 1.7% | |
| Sample 3 | 34.5 | 0.5% | 0.8% | |
| Sample 4 | 39.6 | 0.7% | 0.8% | |
| Sample 5 | 52.1 | 1.0% | 1.7% | |
| Sample 6 | 48.3 | 0.9% | 1.4% | |
| Sample | Mean | |||
| INR | Repeatability | |||
| CV | Within | |||
| Laboratory CV | ||||
| Sample 1 | 1.81 | 1.0% | 1.2% | |
| Sample 2 | 2.76 | 1.7% | 2.0% | |
| Sample 3 | 3.04 | 0.7% | 0.9% | |
| Sample 4 | 3.52 | 0.7% | 0.8% | |
| Sample 5 | 4.66 | 1.2% | 1.7% | |
| Sample 6 | 4.31 | 1.2% | 1.5% |
Prothrombin Time (PT) Precision
8
| Prothrombin Time (PT) Precision | ||||
|---|---|---|---|---|
| System | Sample | Mean PT (Seconds) | Repeatability CV | Within Laboratory CV |
| ACL TOP Family | ||||
| 50 Series | Normal Control | 11.8 | 0.7% | 1.0% |
| Low Abnormal Control | 23.3 | 0.8% | 0.9% | |
| High Abnormal Control | 38.4 | 1.0% | 1.0% | |
| Sample 1 | 21.4 | 0.7% | 1.0% | |
| Sample 2 | 33.0 | 0.8% | 1.0% | |
| Sample 3 | 36.2 | 0.7% | 1.0% | |
| Sample 4 | 41.6 | 0.7% | 1.2% | |
| Sample 5 | 53.2 | 1.1% | 1.7% | |
| Sample 6 | 48.6 | 0.9% | 1.6% | |
| Sample | Mean INR | Repeatability CV | Within Laboratory CV | |
| Sample 1 | 1.79 | 0.8% | 1.1% | |
| Sample 2 | 2.79 | 1.0% | 1.0% | |
| Sample 3 | 3.07 | 0.9% | 1.0% | |
| Sample 4 | 3.54 | 1.2% | 1.4% | |
| Sample 5 | 4.56 | 1.5% | 2.0% | |
| Sample 6 | 4.16 | 1.2% | 1.7% |
| Fibrinogen (Fib) Precision | |||||
|---|---|---|---|---|---|
| System | Sample | Mean Fib | |||
| (mg/dL) | Repeatability | ||||
| CV | Within | ||||
| Laboratory CV | |||||
| ACL TOP Family | Normal Control | 329 | 1.1% | 1.2% | |
| Low Abnormal Control | 171 | 1.2% | 1.5% | ||
| Low Fibrinogen Control | 130 | 1.8% | 2.0% | ||
| Sample 1 | 111 | 1.1% | 1.2% | ||
| Sample 2 | 116 | 1.1% | 1.5% | ||
| Sample 3 | 315 | 0.6% | 0.8% | ||
| Sample 4 | 338 | 0.8% | 0.9% | ||
| Sample 5 | 626 | 0.6% | 0.8% | ||
| Sample 6 | 636 | 0.8% | 1.0% |
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| Fibrinogen (Fib) Precision | |||||||
|---|---|---|---|---|---|---|---|
| System | Sample | Mean Fib | |||||
| (mg/dL) | Repeatability | ||||||
| CV | Within | ||||||
| Laboratory CV | |||||||
| ACL TOP Family | |||||||
| 50 Series | Normal Control | 319 | 1.3% | 1.4% | |||
| Low Abnormal Control | 157 | 1.0% | 1.4% | ||||
| Low Fibrinogen Control | 122 | 2.0% | 2.3% | ||||
| Sample 1 | 106 | 1.2% | 1.4% | ||||
| Sample 2 | 110 | 1.1% | 1.3% | ||||
| Sample 3 | 307 | 0.9% | 1.2% | ||||
| Sample 4 | 330 | 0.6% | 0.9% | ||||
| Sample 5 | 624 | 0.7% | 1.1% | ||||
| Sample 6 | 635 | 0.8% | 1.2% |
Fibrinogen Linearity
Fibrinogen linearity was assessed in accordance with CLSI EP06, 2nd Ed, using 3 lots of HemosIL ReadiPlasTin on representative members of the ACL TOP Family and ACL TOP Family 50 Series. The results for all 3 lots on both systems met acceptance criteria, supporting the labeled fibrinogen linearity claim of 60 to 700 mg/dL.
Interference
Interference was assessed for conjugated bilirubin and daptomycin in accordance with CLSI EP07, 3d Ed, and CLSI EP37, 1* Ed, using 1 lot of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. The studies used two clinical sample levels each for PT (normal pooled plasma and a high NR clinical sample at 2.0-3.0 INR) and fibrinogen (normal pooled plasma and a low fibrinogen sample at ~100 mg/dL).
The results from these additional studies, along with the original interference studies under K122584, support the following labeled claims of no interference for:
| UFH | LMWH | Hemoglobin | Triglycerides | Bilirubin
(Conjugated
and
Unconjugated) | Daptomycin |
|-----------------------|-----------|------------|---------------|--------------------------------------------------|-------------|
| Prothrombin Time (PT) | | | | | |
| 1.0 IU/mL | 1.4 IU/mL | 500 mg/dL | 1000 mg/dL | 50 mg/dL | 100 µg/mL |
| Fibrinogen | | | | | |
| 1.5 IU/mL | 1.7 IU/mL | 500 mg/dL | 600 mg/dL | 50 mg/dL | 200 µg/mL |
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Method Comparison
In-house method comparison was performed in accordance with CLSI EP09c on normal and abnormal samples, comparing HemosIL ReadiPlasTin to HemosIL RecombiPlasTin 2G on a representative member of the ACL TOP Family and a representative member of the ACL TOP Family 50 Series, with the following result(s):
| System | Assay | n | Slope
(95% CI) | Intercept
(95% CI) | r |
|--------------------------------|-----------------------|-----|-------------------------|----------------------------|-------|
| ACL TOP
Family | PT
(INR) | 160 | 1.031
(1.009, 1.053) | -0.043
(-0.068, -0.018) | 0.997 |
| | PT
(INR) | 51 | 1.042
(1.006, 1.078) | 0.011
(-0.072, 0.094) | 0.998 |
| | Fibrinogen
(mg/dL) | 135 | 0.975
(0.963, 0.986) | 7.171
(3.842, 10.50) | 0.995 |
| ACL TOP
Family 50
Series | PT
(INR) | 160 | 1.021
(0.999, 1.043) | -0.034
(-0.060, -0.009) | 0.996 |
| | PT
(INR) | 51 | 1.029
(0.992, 1.067) | 0.023
(-0.061, 0.107) | 0.997 |
| | Fibrinogen
(mg/dL) | 134 | 1.015
(1.003, 1.027) | -0.811
(-4.148, 2.527) | 0.994 |
Open Vial Stability
Open vial stability was assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples, were tested in eight replicates at each time interval to a point past claim; for fibrinogen, controls and six fibrinogen sample pools at three levels, were tested in eight replicates at each time interval to a point past claim.
The results support the following labeled open vial stability claim:
- Once prepared for use, 10 days at 2-8℃ in closed original vial -
On-board Instrument Stability
On-board instrument stability was assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples, were tested in eight replicates at each time interval to a point past claim; for fibrinogen, controls and six fibrinogen sample pools at three levels, were tested in eight replicates at each time interval to a point past claim.
The results support the following labeled on-board instrument stability claim:
- Once prepared for use, 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series
11
Real-time Shelf-life Stability
Real-time shelf-life stability continues to be assessed in accordance with CLSI EP25-A, using 3 lots of HemosIL ReadiPlasTin on a representative member of the ACL TOP Family. For PT, controls and four native (unadulterated) patient samples were tested in eight replicates at Time 0 and this testing continues at each predefined time interval; for fibrinogen sample pools at three levels, were tested in eight replicates at Time 0 and this testing continues at each predefined time interval. The study will continue to a point past final claim.
Conclusion
Results of the performance and stability studies for HemosIL ReadiPlasTin, with the modified formulation, demonstrate that the subject device is substantially equivalent to the predicate device, HemosIL ReadiPlasTin, last FDA cleared under K122584.