(221 days)
Not Found
No
The description focuses on standard statistical calculations (mean, %CV, orthogonal regression) and predefined thresholds (± 15%). There is no mention of adaptive learning, pattern recognition beyond simple statistical analysis, or any other characteristics typically associated with AI/ML.
No
This device is designed for in vitro diagnostic use, specifically for monitoring the accuracy of INR reporting and establishing local ISI and MNPT for laboratory testing. It does not directly treat or diagnose a disease or condition in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The device is used to monitor the accuracy of INR reporting and establish a laboratory's instrument/reagent specific local ISI, which are diagnostic indicators.
No
The device description clearly outlines two physical components, HemosIL INR Validate and HemosIL ISI Calibrate, which are sets of control and calibration plasmas. While the ISIweb Software is a software component, it is used in conjunction with these physical components for data entry and calculation, not as a standalone software device performing the primary medical function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Nature of the Device: The device components (control plasmas, calibration plasmas, and software) are used to monitor and calibrate the accuracy of INR reporting, which is a laboratory test performed on patient samples (plasma) in vitro (outside the body).
- Purpose: The purpose is to ensure the reliability of a diagnostic test (PT/INR) used to assess a patient's coagulation status, which is a key aspect of in vitro diagnostics.
N/A
Intended Use / Indications for Use
- HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's instrument/ reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- ISIweb Software is a web-based service to customers, used in conjunction with HemosIL INR Validate and HemosIL ISI Calibrate with designated HemosIL PT reagents on IL Coagulation Systems; whereby the PT seconds and INR results can be entered and calculated through a web-based interface (ISIweb software).
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
GGN, JIS, JQP
Device Description
HemosIL INR Validate: The HemosIL INR Validate set consists of three control plasmas (Levels 1-3) with assigned INR (International Normalized Ratio) Reference Values in the range of 1.6 - 5.0, prepared using lyophilized citrated plasma from human donors on stable anti-vitamin K therapy (AVK). The reference INR values for each Level are reagent-specific for the IL coagulation systems. The plasma factors (II, VII, IX, X, PC & PS) in these controls are similar to levels normally expected in plasma from patients undergoing long-term oral anticoagulant therapy, together with the proteins induced by vitamin K antagonists (PIKVA inhibitors). The control plasmas of HemosIL INR Validate are run on a local instrument/reagent system using the manufacturer's lot-specific label ISI value and the laboratory's locally establishied lot-specific Mean Normal Prothrombin Time (MNPT).
If the mean INRs of all the controls are within ± 15% of their assigned INR Reference Values as determined through the ISIweb, the PT/INR system is verified.
If the mean INRs of the controls exceed ± 15% of their assigned INR Reference Values as determined through the ISIweb a new local ISI calibration is recommended using HemosIL ISI Calibrate. Verification of the new local ISI and MNPT is then performed by running the HemosIL INR Validate control plasmas a second time on the same instrument/reagent system with the local ISI and MNPT.
HemosIL ISI Calibrate: The HemosIL ISI Calibrate set contains four calibration plasmas (Levels A-D) with assigned INR (International Normalized Ratio) Reference Values in the range of 0.9 - 5.0 for standardizing the PT test on IL Coagulation Systems. These INR Reference Values are reagent specific for the IL Coagulation Systems. Level A is a lyophilized normal human pool produced from the selected citrated plasmas of healthy donors. Levels B-D are lyophilized citrated plasmas produced from a pool of human donors on long-term oral anticoagulant therapy (antivitamin K: AVK). The plasma factors (II, VII, IX, X, PC, & PS) are similar to those levels normally expected in plasma from patients undergoing long term oral anticoagulant therapy together with protein induced by vitamin K antagonists (PIVKA inhibitors). The calibrate plasmas from HemosIL ISI Calibrate are run on the laboratory's IL instrument/reagent system to establish a local ISI. The PT (sec) data is entered into the ISIweb, which generates a calibration curve from the PT and the INR Reference Values by plotting an orthogonal regression of LogINR (X-axis) vs. LogPT (Y-axis). The ISI and Mean Normal Prothrombin Time (MNPT) are derived from the slope and y-intercept of the curve as: ISI = Tslope sub MNP; MNP = TO super y-intercept.
ISIweb Software: When used in conjunction with HemosIL INR Validate, ISIweb will automatically calculate the mean INR for each control level and verify that the mean INR for each control level is within ± 15% of the assigned INR Reference Value.
When used in conjunction with HemosIL ISI Calibrate, ISIweb will automatically calculate the mean PT and %CV value for each level. If the %CV for each level passes % CV specifications, the ISIweb generates a calibration curve from the PT and INR Reference Values by plotting an orthogonal regression of LogINR (X-axis) vs. LogPT (y-axis).
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)
A precision study conducted in accordance to CLSI EP05-A2 (20 days; 2 replicates per run; 2 runs per day; N=80 per level) on the three levels of HemosIL INR Validate and four levels of HemosIL ISI Calibrate using IL HemosIL PT reagents on representative IL Coagulation Systems. Key results are shown in the tables under "Summary Performance Data" which list Mean (Seconds), Within-Run % CV, and Total % CV for various reagents, instruments, and levels of HemosIL INR Validate and HemosIL ISI Calibrate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean (Seconds), Within-Run % CV, Total % CV.
For HemosIL INR Validate:
Mean (Seconds) ranges from 21.2 to 68.3.
Within-Run % CV ranges from 0.4 to 4.1.
Total % CV ranges from 1.5 to 4.4.
For HemosIL ISI Calibrate:
Mean (Seconds) ranges from 10.7 to 68.8.
Within-Run % CV ranges from 0.1 to 4.4.
Total % CV ranges from 1.1 to 4.9.
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.
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
510(k) Summary
Applicant Contact Information:
OCT - 9 2009
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 113 Hartwell Avenue |
| Lexington, MA 02421 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
Preparation Date: February 27, 2009
Device Trade Names (Products Sold Separately):
- HemosIL® INR Validate HemosIL® ISI Calibrate
ISIweb Software
Device Regulatory Information:
| Controls: | Class II | Product Code: GGN | 21 CFR 864.5425 |
|---|---|---|---|
| Calibrators: | Class II | Product Code: JIS | 21 CFR 862.1150 |
Predicate Devices:
| HemosIL INR Validate | K010750 | Pacific Hemostasis INR Control Plasmas |
|---|---|---|
| HemosIL ISI Calibrate | K041905 | HemosIL Calibration Plasma |
Device Intended Uses:
- HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR . (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's ● instrument/reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- ISIweb Software is a web-based service to customers, used in conjunction with HemosIL INR . Validate and HemosIL ISI Calibrate with designated HemosIL PT reagents on IL Coagulation Systems, whereby the PT seconds and INR results can be entered and calculated through a web-based interface (ISIweb software).
1
Device Descriptions:
. HemosIL INR Validate
The HemosIL INR Validate set consists of three control plasmas (Levels 1-3) with assigned INR (International Normalized Ratio) Reference Values in the range of 1.6 - 5.0, prepared using lyophilized citrated plasma from human donors on stable anti-vitamin K therapy (AVK). The reference INR values for each Level are reagent-specific for the IL coagulation systems. The plasma factors (II, VII, IX, X, PC & PS) in these controls are similar to levels normally expected in plasma from patients undergoing long-term oral anticoagulant therapy, together with the proteins induced by vitamin K antagonists (PIKVA inhibitors).
The control plasmas of HemosIL INR Validate are run on a local instrument/reagent system using the manufacturer's lot-specific label ISI value and the laboratory's locally establishied lot-specific Mean Normal Prothrombin Time (MNPT).
- . If the mean INRs of all the controls are within ± 15% of their assigned INR Reference Values as determined through the ISIweb, the PT/INR system is verified.
- If the mean INRs of the controls exceed ± 15% of their assigned INR Reference Values . as determined through the ISIweb a new local ISI calibration is recommended using HemosIL ISI Calibrate. Verification of the new local ISI and MNPT is then performed by running the HemosIL INR Validate control plasmas a second time on the same instrument/reagent system with the local ISI and MNPT.
- HemosIL ISI Calibrate .
The HemosIL ISI Calibrate set contains four calibration plasmas (Levels A-D) with assigned INR (International Normalized Ratio) Reference Values in the range of 0.9 - 5.0 for standardizing the PT test on IL Coagulation Systems. These INR Reference Values are reagent specific for the IL Coagulation Systems. Level A is a lyophilized normal human pool produced from the selected citrated plasmas of healthy donors. Levels B-D are lyophilized citrated plasmas produced from a pool of human donors on long-term oral anticoagulant therapy (antivitamin K: AVK). The plasma factors (II, VII, IX, X, PC, & PS) are similar to those levels normally expected in plasma from patients undergoing long term oral anticoagulant therapy together with protein induced by vitamin K antagonists (PIVKA inhibitors).
The calibrate plasmas from HemosIL ISI Calibrate are run on the laboratory's IL instrument/reagent system to establish a local ISI. The PT (sec) data is entered into the ISIweb, which generates a calibration curve from the PT and the INR Reference Values by plotting an orthogonal regression of LogINR (X-axis) vs. LogPT (Y-axis). The ISI and Mean Normal Prothrombin Time (MNPT) are derived from the slope and y-intercept of the curve as:
$$\mathsf{ISI} = \mathsf{T}\mathsf{slope}_{\mathsf{MNP}} \ \mathsf{MNP} = \mathsf{T}\mathsf{O}^{\mathsf{y}\text{-intercept}}$$
t ISIweb Software
When used in conjunction with HemosIL INR Validate, ISIweb will automatically calculate the mean INR for each control level and verify that the mean INR for each control level is within ± 15% of the assigned INR Reference Value.
When used in conjunction with HemosIL ISI Calibrate, ISIweb will automatically calculate the mean PT and %CV value for each level. If the %CV for each level passes % CV specifications, the ISIweb generates a calibration curve from the PT and INR Reference Values by plotting an orthogonal regression of LogINR (X-axis) vs. LogPT (y-axis).
Attachment B
K090563: HemosIL INR Validate, HemosIL ISI Calibrate, ISIweb
2
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
- HemosIL INR Validate is substantially equivalent in performance and intended use to Pacific . Hemostasis INR Control Plasmas (K010750).
- HemosIL ISI Calibrate is the same type of device as HemosIL Calibration Plasma and in . compliance with establishing a local ISI assignment following CLSI H54-A - Procedures for Validation of INR and Local ISI Calibration of PT/INR Systems or 1STH - Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination.
Summary Performance Data:
A precision study conducted in accordance to CLSI EP05-A2 (20 days; 2 replicates per run; 2 runs per day; N=80 per level) on the three levels of HemosIL INR Validate and four levels of HemosIL ISI Calibrate using IL HemosIL PT reagents on representative IL Coagulation Systems:
| HemosIL INR Validate (Levels 1-3) | |||||
|---|---|---|---|---|---|
| Reagent | Instrument | Level | Mean | ||
| (Seconds) | Within-Run | ||||
| % CV | Total | ||||
| % CV | |||||
| HemosIL | |||||
| RecombiPlasTin | ACL TOP | 1 | 28.1 | 1.2 | 1.5 |
| ACL 10000 | 1 | 27.2 | 1.0 | 2.1 | |
| HemosIL | |||||
| RecombiPlasTin | ACL TOP | 2 | 43.5 | 1.0 | 2.5 |
| ACL 10000 | 2 | 41.4 | 1.3 | 3.1 | |
| HemosIL | |||||
| RecombiPlasTin | ACL TOP | 3 | 68.3 | 2.8 | 3.5 |
| ACL 10000 | 3 | 65.5 | 1.0 | 1.5 | |
| HemosIL | |||||
| RecombiPlasTin 2G | ACL TOP | 1 | 22.3 | 2.0 | 2.5 |
| ACL 10000 | 1 | 21.2 | 0.9 | 1.9 | |
| HemosIL | |||||
| RecombiPlasTin 2G | ACL TOP | 2 | 33.9 | 0.9 | 1.8 |
| ACL 10000 | 2 | 32.0 | 1.2 | 3.0 | |
| HemosIL | |||||
| RecombiPlasTin 2G | ACL TOP | 3 | 53.2 | 4.1 | 4.4 |
| ACL 10000 | 3 | 51.4 | 1.2 | 2.0 | |
| HemosIL | |||||
| PT-Fibrinogen | |||||
| HS PLUS | ACL TOP | 1 | 24.7 | 1.3 | 2.5 |
| ACL 10000 | 1 | 24.5 | 0.7 | 1.7 | |
| HemosIL | |||||
| PT-Fibrinogen | |||||
| HS PLUS | ACL TOP | 2 | 35.4 | 1.6 | 2.7 |
| ACL 10000 | 2 | 34.6 | 1.2 | 2.2 | |
| HemosIL | |||||
| PT-Fibrinogen | |||||
| HS PLUS | ACL TOP | 3 | 50.5 | 3.5 | 4.2 |
| ACL 10000 | 3 | 48.0 | 1.5 | 3.4 | |
| HemosIL | |||||
| PT-Fibrinogen HS* | ACL 10000 | 1 | 21.2 | 0.9 | 1.9 |
| ACL 10000 | 2 | 32.0 | 1.2 | 3.0 | |
| HemosIL | |||||
| PT-Fibrinogen HS* | ACL 10000 | 3 | 51.4 | 1.2 | 2.0 |
| HemosIL | |||||
| PT-Fibrinogen | ACL TOP | 1 | 16.6 | 0.4 | 2.1 |
| ACL 10000 | 1 | 17.5 | 0.7 | 2.2 | |
| HemosIL | |||||
| PT-Fibrinogen | ACL TOP | 2 | 21.0 | 0.4 | 3.4 |
| ACL 10000 | 2 | 22.4 | 0.7 | 3.6 | |
| HemosIL | |||||
| PT-Fibrinogen | ACL TOP | 3 | 27.5 | 0.4 | 3.9 |
| ACL 10000 | 3 | 29.8 | 1.9 | 4.1 |
- Application not currently available for HemosIL PT-Fibrinogen HS on the ACL TOP family.
K090563: HemosIL INR Validate, HemosIL ISI Calibrate, ISIweb
3
510(k) Summary (Cont.)
Summary Performance Data (Cont.):
:
| HemosIL ISI Calibrate (Levels A-D) | |||||
|---|---|---|---|---|---|
| Reagent | Instrument | Level | Mean | ||
| (Seconds) | Within-Run | ||||
| % CV | Total | ||||
| % CV | |||||
| HemosIL | |||||
| RecombiPlasTin | ACL TOP | A | 12.1 | 1.2 | 1.3 |
| ACL 10000 | A | 11.8 | 0.6 | 1.1 | |
| ACL TOP | B | 29.5 | 0.8 | 1.2 | |
| ACL 10000 | B | 27.9 | 1.3 | 2.0 | |
| ACL TOP | C | 43.7 | 0.7 | 1.2 | |
| ACL 10000 | C | 42.2 | 0.7 | 1.1 | |
| ACL TOP | D | 68.8 | 4.4 | 4.6 | |
| ACL 10000 | D | 66.9 | 0.8 | 2.0 | |
| HemosIL | |||||
| RecombiPlasTin 2G | ACL TOP | A | 11.2 | 1.5 | 1.6 |
| ACL 10000 | A | 10.7 | 0.8 | 1.2 | |
| ACL TOP | B | 23.2 | 1.2 | 2.2 | |
| ACL 10000 | B | 21.4 | 1.3 | 2.2 | |
| ACL TOP | C | 33.9 | 1.0 | 1.7 | |
| ACL 10000 | C | 31.6 | 1.0 | 2.0 | |
| ACL TOP | D | 50.8 | 4.4 | 4.9 | |
| ACL 10000 | D | 48.5 | 1.0 | 2.2 | |
| HemosIL | |||||
| PT-Fibrinogen | |||||
| HS PLUS | ACL TOP | A | 13.4 | 1.0 | 2.1 |
| ACL 10000 | A | 13.5 | 1.2 | 2.1 | |
| ACL TOP | B | 24.0 | 1.8 | 2.5 | |
| ACL 10000 | B | 23.7 | 1.1 | 4.2 | |
| ACL TOP | C | 35.1 | 1.2 | 2.2 | |
| ACL 10000 | C | 35.2 | 1.1 | 1.8 | |
| ACL TOP | D | 50.4 | 3.4 | 3.9 | |
| ACL 10000 | D | 50.1 | 0.8 | 2.0 | |
| HemosIL | |||||
| PT-Fibrinogen HS* | ACL 10000 | A | 10.7 | 0.1 | 1.2 |
| ACL 10000 | B | 21.4 | 1.3 | 2.2 | |
| ACL 10000 | C | 31.6 | 1.0 | 2.0 | |
| ACL 10000 | D | 48.5 | 1.0 | 2.2 | |
| HemosIL | |||||
| PT-Fibrinogen | ACL TOP | A | 11.7 | 0.9 | 1.8 |
| ACL 10000 | A | 11.9 | 0.8 | 1.4 | |
| ACL TOP | B | 16.0 | 0.4 | 2.3 | |
| ACL 10000 | B | 16.8 | 0.7 | 2.3 | |
| ACL TOP | C | 20.7 | 0.3 | 2.9 | |
| ACL 10000 | C | 22.2 | 0.9 | 3.0 | |
| ACL TOP | D | 26.6 | 0.4 | 3.7 | |
| ACL 10000 | D | 28.8 | 0.4 | 3.5 |
- Application not currently available for HemosIL PT-Fibrinogen HS on the ACL TOP family.
・・・・
:
Attachment B
K090563: HemosIL INR Validate, HemosIL ISI Calibrate, ISIweb
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
OCT - 9 2009
Instrumentation Laboratory Co. c/o Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
Re: K090563
Trade/Device Name: HemosIL INR Validate, HemosIL ISI Calibrate, and ISI web software Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN, JIS, JQP Dated: September 1, 2009
Received: September 2, 2009
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
5
Page 2 - Ms. Marble
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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
K090563 510(k) Number (if known):
Device Name:
HemosIL® INR Validate HemosIL® ISI Calibrate ISIweb Software
Indications for Use:
- � HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's . instrument/ reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with designated Hemos)L PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
- ISIweb Software is a web-based service to customers, used in conjunction with HemosIL INR . Validate and HemosIL ISI Calibrate with designated HemosIL PT reagents on IL Coagulation Systems; whereby the PT seconds and INR results can be entered and calculated through a web-based interface (ISIweb software).
For in vitro diagnostic use.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090563
Attachment A HemosIL INR Validate, HemosIL ISI Calibrate, ISIweb Software 510(k) Page 1 of 1