(224 days)
Not Found
No
The description focuses on a chemical reagent and its interaction with plasma, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an in vitro diagnostic reagent used to determine Prothrombin Time (PT) and Fibrinogen, which are diagnostic measurements for evaluating coagulation pathways and monitoring therapy, not for providing therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "for the quantitative in vitro diagnostic determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only."
No
The device is a reagent (chemical substance) used for in vitro diagnostic testing, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The document explicitly states "for the quantitative in vitro diagnostic determination in human citrated plasma". This directly indicates its use for diagnostic purposes outside of the living body.
- Device Description: The description details how the reagent interacts with patient plasma to initiate a reaction that is then measured to determine coagulation parameters. This is a typical process for in vitro diagnostic tests.
- Summary of Performance Studies: The performance studies described (Precision, Method Comparison, Expected Values) are standard types of studies conducted to validate the performance of an in vitro diagnostic device.
- Predicate Device(s): The mention of a predicate device (HemosIL RecombiPlasTin) with a K number (K043184) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for medical devices, including IVDs.
N/A
Intended Use / Indications for Use
HemosIL RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only.
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Product codes (comma separated list FDA assigned to the subject device)
81GJS, 81GIS
Device Description
The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G 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 fibringen to fibrin, with formation of a solid gel. For the IL Coagulation Systems only, 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
Not Found
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)
Precision:
Within run and total precision assessed over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen.
Key results included CV % for different IL Coagulation Systems and control levels.
Method Comparison - In-house:
An in-house method comparison study was performed with modified RecombiPlasTin 2G versus the current HemosIL RecombiPlasTin.
Results include Slope, Intercept, and r values for PT and Fibrinogen assays on various IL Coagulation Systems.
Method Comparison - Field Site:
Two field site method comparison studies were performed with modified RecombiPlasTin 2G versus the current HemosIL RecombiPlasTin.
Results include Slope, Intercept, and r values for PT (Sec.), PT INR, and Fibrinogen (mg/dL) on ACL TOP and ACL 10000 systems.
Expected Values:
A normal range study was performed using the modified RecombiPlasTin 2G reagent.
PT normal ranges determined for ELECTRA, ACL Family, ACL Futura/ACL Advance, and ACL TOP systems (N=130 for each).
Fibrinogen normal ranges determined for ACL Family, ACL Futura/ACL Advance, and ACL TOP systems (N=129 for each).
CUBICIN (Daptomycin for injection) Dose-Response Testing:
An in vitro study indicated no clinically significant CUBICIN (Daptomycin for injection) dose response with the modified HemosIL RecombiPlasTin 2G.
Specifications: Normal Sample ± 1 second from unspiked sample; Coumadin Sample ± 10% recovery of the unspiked sample. Expected peak dosing for CUBICIN is 75 μg/mL.
Data provided for ACL 6000, ACL 10000, ACL Advance, ACL TOP, and ELECTRA 1600C Coagulation Analyzers, showing PT Seconds and % Recovery for various CUBICIN concentrations (0-125 μg/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision: CV% (Within run) and CV% (Total). Method Comparison: Slope, Intercept, and r values. CUBICIN Dose-Response: Change in Seconds and % Recovery.
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.
HemosIL RecombiPlasTin K043184
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7750 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
KO70005
510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207
Prepared:
June 28, 2007
Device Name:
HemosIL RecombiPlasTin 2G
Regulatory Information:
| 864.7750 | Prothrombin Time Test | Class II |
|---|---|---|
| 81GJS | Test, Time, Prothrombin | |
| 864.7340 | Fibrinogen Determination System | Class II |
| 81GIS | Test, Fibrinogen |
Predicate Device:
HemosIL RecombiPlasTin K043184
Device Description:
The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G 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 fibringen to fibrin, with formation of a solid gel. For the IL Coagulation Systems only, the Fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.
Device Intended Use:
HemosIL RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only.
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of HemosIL RecombiPlasTin 2G with a modified phospholivid ratio is not materially different from the FDA cleared device: HemosIL RecombiPlasTin (K043184).
Attachment D
AUG 1 5 2007
Page 1 of 5
1
510(k) Summary (Cont.)
Summary of Performance Data:
Precision
Within run and total precision assessed over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen gave the following results:
| ELECTRA | Mean (PT seconds) | CV % (Within run) | CV % (Total) |
|---|---|---|---|
| Normal | 12.2 | 1.3 | 1.9 |
| Low Abnormal | 21.1 | 1.2 | 2.6 |
| High Abnormal | 31.3 | 1.3 | 3.4 |
| ACL Family | Mean (PT seconds) | CV % (Within run) | CV % (Total) |
| Normal | 11.7 | 0.6 | 1.5 |
| Low Abnormal | 21.6 | 1.0 | 1.9 |
| High Abnormal | 32.9 | 1.1 | 2.6 |
| ACL Futura/ACL Advance | Mean (PT seconds) | CV % (Within run) | CV % (Total) |
| Normal | 12.5 | 1.1 | 1.9 |
| Low Abnormal | 23.8 | 1.6 | 1.9 |
| High Abnormal | 36.0 | 1.8 | 2.4 |
| ACL TOP | Mean (PT seconds) | CV % (Within run) | CV % (Total) |
| Normal | 11.9 | 0.8 | 2.2 |
| Low Abnormal | 22.0 | 0.8 | 3.1 |
| High Abnormal | 34.0 | 0.9 | 3.1 |
| ACL Family | Mean (Fibrinogen mg/dL) | CV % (Within run) | CV % (Total) |
| Normal | 319 | 4.2 | 5.0 |
| Low Fibrinogen Control | 149 | 5.9 | 6.9 |
| ACL Futura/ | |||
| ACL Advance | Mean (Fibrinogen mg/dL) | CV % (Within run) | CV % (Total) |
| Normal | 229 | 3.0 | 3.1 |
| Low Fibrinogen Control | 157 | 3.7 | 4.5 |
| ACL TOP | Mean (Fibrinogen mg/dL) | CV % (Within run) | CV % (Total) |
| Normal | 296 | 1.4 | 2.4 |
| Low Fibrinogen Control | 135 | 2.9 | 3.6 |
2
510(k) Summary (Cont.)
Summary of Performance Data (Cont.):
Method Comparison - In-house
An in-house method comparison study was performed with modified RecombiPlasTin 2G versus the current HemosIL RecombiPlasTin:
| System | Assay | Slope | Intercept | r | Reference Method |
|---|---|---|---|---|---|
| ELECTRA | PT | ||||
| (Seconds) | 0.7637 | 3.0427 | 0.9789 | HemosIL RTF on ELECTRA | |
| ACL Family | 0.7910 | 2.7860 | 0.9885 | HemosIL RTF on ACL Family | |
| ACL Futura/ | |||||
| ACL Advance | 0.8075 | 2.8899 | 0.9913 | HemosIL RTF on ACL Advance | |
| ACL TOP | 0.8010 | 2.7138 | 0.9916 | HemosIL RTF on ACL TOP | |
| ACL Family | Fibrinogen | ||||
| (mg/dL) | 0.9350 | 6.1043 | 0.9866 | Fibrinogen (PT-Fib based) on | |
| ACL Family | |||||
| ACL Futura/ | |||||
| ACL Advance | 0.9711 | 10.933 | 0.9783 | Fibrinogen (PT-Fib based) on | |
| ACL Advance | |||||
| ACL TOP | 1.0129 | -3.6298 | 0.9969 | Fibrinogen (PT-Fib based) on | |
| ACL TOP |
Method Comparison - Field Site
Two field site method comparison studies were performed with modified RecombiPlasTin 2G versus the current HemosIL RecombiPlasTin:
| System | Assay | Slope | Intercept | r | Reference Method |
|---|---|---|---|---|---|
| ACL TOP | PT (Sec.) | 0.8137 | 4.0035 | 0.9934 | |
| ACL TOP | PT INR | 1.0838 | -0.1071 | 0.9945 | HemosIL RTF on ACL TOP |
| ACL TOP | Fibrinogen (mg/dL) | 0.9805 | 5.3466 | 0.9946 | |
| System | Assay | Slope | Intercept | r | Reference Method |
| ACL 10000 | PT (Sec.) | 0.7935 | 2.1733 | 0.9887 | |
| ACL 10000 | PT INR | 0.9446 | 0.0367 | 0.9881 | HemosIL RTF on ACL 10000 |
| ACL 10000 | Fibrinogen (mg/dL) | 0.9431 | 7.5763 | 0.9832 |
Expected Values
A normal range study was performed using the modified RecombiPlasTin 2G reagent:
| PT | N | Range |
|---|---|---|
| • ELECTRA | 130 | 9.8 - 12.2 (seconds) |
| • ACL Family | 130 | 9.1 - 12.1 (seconds) |
| • ACL Futura/ACL Advance | 130 | 9.9 - 12.9 (seconds) |
| • ACL TOP | 130 | 9.4 - 12.5 (seconds) |
| Fibrinogen | N | Range |
| • ACL Family | 129 | 308 - 613 (mg/dL) |
| • ACL Futura/ACL Advance | 129 | 222 - 340 (mg/dL) |
| • ACL TOP | 129 | 276 - 471 (mg/dL) |
*NOTE: The product insert advises customers that "These results were obtained using a specific lot of reagent. Due to many variables which may affect clotting times, each laboratory should establish its own normal range."
3
510(k) Summary (Cont.) (Summary of Safety and Effectiveness)
Summary of Performance Data (Cont.):
CUBICIN (Daptomycin for injection) Dose-Response Testing
An in vitro study indicated no clinically significant CUBICIN (Daptomycin for injection) dose response with the modified HemosIL RecombiPlasTin 2G using the following specifications:
- NOTE: The expected peak dosing for CUBICIN (Daptomycin for injection) in circulating blood is 75μg/mL.
- Normal Sample ± 1 second from unspiked sample .
- . Coumadin Sample ± 10% recovery of the unspiked sample
Data from this testing on representative IL Coagulation Systems are provided below:
| ACL 6000 Coagulation Analyzer | ||||
|---|---|---|---|---|
| CUBICIN | ||||
| Concentration | ||||
| (µg/mL) | Normal Sample | |||
| (PT Seconds) | Change in | |||
| Seconds | Coumadin Sample | |||
| (PT Seconds) | % Recovery | |||
| 0 | 10.5 | -- | 22.5 | -- |
| 1 | 10.5 | 0.0 | 22.7 | 101% |
| 10 | 10.6 | 0.1 | 23.0 | 102% |
| 25 | 10.5 | 0.0 | 23.4 | 104% |
| 50 | 10.6 | 0.1 | 24.0 | 107% |
| 100 | 10.9 | 0.4 | 24.8 | 110% |
| 125 | 11.0 | 0.5 | 24.7 | 110% |
| ACL 10000 Coagulation Analyzer | ||||
|---|---|---|---|---|
| CUBICIN | ||||
| Concentration | ||||
| (µg/mL) | Normal Sample | |||
| (PT Seconds) | Change in | |||
| Seconds | Coumadin Sample | |||
| (PT Seconds) | % Recovery | |||
| 0 | 11.7 | -- | 25.1 | -- |
| 1 | 11.7 | 0.0 | 25.3 | 101% |
| 10 | 11.8 | 0.1 | 25.7 | 102% |
| 25 | 11.9 | 0.2 | 25.9 | 103% |
| 50 | 12.0 | 0.3 | 26.4 | 105% |
| 100 | 12.4 | 0.7 | 26.9 | 107% |
| 125 | 12.4 | 0.7 | 27.5 | 110% |
4
510(k) Summary (Cont.) (Summary of Safety and Effectiveness)
Summary of Performance Data (Cont.):
| ACL Advance Coagulation Analyzer | ||||
|---|---|---|---|---|
| CUBICIN | ||||
| Concentration | ||||
| (µg/mL) | Normal Sample | |||
| (PT Seconds) | Change in | |||
| Seconds | Coumadin Sample | |||
| (PT Seconds) | % Recovery | |||
| 0 | 12.7 | -- | 26.9 | -- |
| 1 | 12.8 | 0.1 | 26.8 | 100% |
| 10 | 12.6 | 0.1 | 27.6 | 103% |
| 25 | 12.8 | 0.1 | 27.3 | 101% |
| 50 | 12.8 | 0.1 | 28.4 | 106% |
| 100 | 13.2 | 0.5 | 29.2 | 109% |
| 125 | 13.2 | 0.5 | 29.5 | 110% |
CUBICIN (Daptomycin for injection) Dose-Response Testing (Cont.)
| ACL TOP Coagulation Analyzer | ||||
|---|---|---|---|---|
| CUBICIN | ||||
| Concentration | ||||
| (µg/mL) | Normal Sample | |||
| (PT Seconds) | Change in | |||
| Seconds | Coumadin Sample | |||
| (PT Seconds) | % Recovery | |||
| 0 | 12.3 | -- | 27.3 | -- |
| 1 | 12.3 | 0.0 | 27.4 | 100% |
| 10 | 12.3 | 0.0 | 27.8 | 102% |
| 25 | 12.5 | 0.2 | 27.8 | 102% |
| 50 | 12.6 | 0.3 | 28.4 | 104% |
| 100 | 12.8 | 0.5 | 29.3 | 107% |
| 125 | 12.9 | 0.6 | 29.7 | 109% |
| ELECTRA 1600C Coagulation Analyzer | ||||
|---|---|---|---|---|
| CUBICIN | ||||
| Concentration | ||||
| (µg/mL) | Normal Sample | |||
| (PT Seconds) | Change in | |||
| Seconds | Coumadin Sample | |||
| (PT Seconds) | % Recovery | |||
| 0 | 12.2 | -- | 23.1 | -- |
| 1 | 12.4 | 0.2 | 23.6 | 102% |
| 10 | 12.3 | 0.1 | 22.0 | 95% |
| 25 | 12.6 | 0.4 | 24.0 | 104% |
| 50 | 12.4 | 0.2 | 24.2 | 105% |
| 100 | 12.8 | 0.6 | 23.4 | 101% |
| 125 | 12.7 | 0.5 | 24.6 | 106% |
Attachment D
HemosIL RecombiPlasTin 2G 510(k)
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 5 2007
Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K070005
Trade/Device Name: HemosIL RecombiPlasTin 2G Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS, GIS Dated: March 22, 2007 Received: March 23, 2007
Dear Ms. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
6
Page 2 -
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Robert H. Becker/
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HemosIL RecombiPlasTin 2G
Indications for Use:
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only.
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
| Prescription Use | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off |
|---|
| ------------------- |
Office of In Vitro Diagnostic Device
Evaluation and SafetyHemosIL RecombiPlasTin 2G 510(k)