(125 days)
Not Found
No
The device description details a standard chromogenic assay based on chemical reactions and kinetic measurements. There is no mention of AI, ML, or any learning algorithms in the intended use, device description, or performance studies. The analysis is based on established biochemical principles and calibrated against known standards.
No.
This device is for in vitro diagnostic use to measure heparin activity in human plasma, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section states: "For the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems... For in vitro diagnostic use." This clearly indicates its purpose is to aid in diagnosis by providing quantitative measurements of substances in human samples.
No
The device description clearly outlines a chromogenic assay based on chemical reactions and the use of lyophilized calibrators and controls. These are physical reagents and components, not software. While the assay is performed on "IL Coagulation Systems," which are likely automated instruments with software, the device being cleared is the assay kit itself, which is a collection of physical materials.
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."
- Intended Use: The device is intended for the quantitative determination of heparin activity in human citrated plasma. This is a diagnostic measurement performed on a biological sample outside of the body.
- Device Description: The description details a chromogenic assay that analyzes components of human plasma (antithrombin, Factor Xa) to determine heparin levels. This is a typical in vitro diagnostic method.
- Calibrators and Controls: The inclusion of calibrators and controls for the assay further indicates its use in a diagnostic laboratory setting to ensure the accuracy and reliability of the test results.
N/A
Intended Use / Indications for Use
- HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO® 8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
KFF, JIS, GGN
Device Description
- HemosIL Liquid Heparin. One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems. Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.
-
- Factor Xa is neutralized by heparin-antithrombin complex.
-
- Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
-
- HemosIL Heparin Calibrators. Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
- HemosIL LMW Heparin Controls (Assayed). Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
- HemosIL UF Heparin Controls (Assayed). Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfranctionated heparin.
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: Precision was assessed over multiple runs using the two levels of both UFH and LMWH Controls on representative IL Coagulation Systems.
Method Comparison - In-house: An in-house method comparison study was performed, using samples from patients undergoing heparin therapy, to compare the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:
IL System: ACL ELITE, n: 124, Slope: 0.894, r: 0.907
IL System: ACL Advance, n: 152, Slope: 1.067, r: 0.946
IL System: ACL TOP, n: 148, Slope: 0.946, r: 0.958
Method Comparison - Field Sites: Three field site studies were performed, using samples from patients undergoing heparin therapy, to note the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:
IL System: ACL ELITE, n: 114, Slope: 1.032, r: 0.949
IL System: ACL Advance, n: 111, Slope: 1.007, r: 0.957
IL System: ACL TOP, n: 81, Slope: 0.952, r: 0.978
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
0
510(k) Summary
Κοροζος
Applicant Contact Information:
JUN - 2 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 |
April 23, 2009 Revision Date:
Device Trade Names (Products Sold Separately):
HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL LMW Heparin Controls HemosIL UF Heparin Controls
Device Regulatory Information:
| Heparin Assay: | Class II | Product Code: KFF | 21 CFR 864.7525 |
|---|---|---|---|
| Calibrators: | Class II | Product Code: JIS | 21 CFR 862.1150 |
| Controls: | Class II | Product Code: GGN | 21 CFR 864.5425 |
Predicate Devices:
| K980242 | HemosIL Heparin |
|---|---|
| K030964 | Calibration Plasma LMW Heparin |
| K030965 | Control Plasma LMW Heparin |
Device Intended Uses:
- HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
- · HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
K090209 - HemosIL Liquid Heparin Assay, Controls and Calibrators Attachment G
Page 1 of 4
电子
1
Device Descriptions:
- HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.
-
- Factor Xa is neutralized by heparin-antithrombin complex.
-
- Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
- HemosIL Heparin Calibrators .
Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
-
HemosIL LMW Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin. -
HemosIL UF Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
- HemosIL Liquid Heparin is substantially equivalent to HemosIL Heparin (K980242) in . performance and intended use.
- HemosIL Heparin Calibrators are substantially equivalent to Calibration Plasma LMW . Heparin (K030964) in performance and intended use, except that the new calibrators are intended for use with both low molecular weight and unfractionated heparin testing.
- HemosIL LMW Heparin Controls and HemosIL UF Heparin Controls are substantially . equivalent to Control Plasma LMW Heparin (K030965) in performance and intended use, except that HemosIL UF Heparin Controls are intended specifically for use with unfractionated heparin testing.
K090209 - HemosIL Liquid Heparin Assay, Controls and Calibrators -Page 2 of 4 Attachment G
2
510(k) Summary (Cont.)
Substantial Equivalence Comparison Table:
| Characteristic | New Device:
HemosIL Liquid Heparin | Predicate Device:
HemosIL Heparin (K980242) | ACL 8/9/1000/ELITE/ELITE PRO | Mean (IU/mL) | CV % (Within run) | CV % (Total) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------|-------------------|--------------|
| Intended Use | Automated chromogenic assay for the
quantitative determination of unfractionated
heparin (UFH) and low molecular weight
heparin (LMWH) activity in human citrated
plasma on IL Coagulation Systems (ACL
TOP® Family, ACL™ ELITE/ELITE
PRO®/8/9/10000 and ACL Futura/ACL
Advance Systems). | Same | UFH Low | 0.39 | 4.0 | 6.7 |
| Form | Liquid Substrate and FXa Reagent | Lyophilized Substrate and FXa Reagent | UFH High | 0.69 | 1.0 | 3.7 |
| Test Principle | Chromogenic Assay | Same | LMWH Low | 0.49 | 5.5 | 5.7 |
| Sample Type | Citrated Plasma | Same | LMWH High | 1.31 | 3.3 | 4.0 |
| Expected Values | To obtain an optimal effect with minimum
risk of bleeding or thromboembolic
complications the heparin activity should be
in the range recommended by the heparin
manufacturer. | Same | ACL Futura/ACL Advance | Mean (IU/mL) | CV % (Within run) | CV % (Total) |
| Linearity | ACL 8/9/1000/ELITE/
ELITE PRO Up to 2.0 IU/mL
ACL Futura/
ACL Advance Up to 2.0 IU/mL
ACL TOP Family Up to 2.0 IU/mL | ACL 8/9/1000/ELITE/
ELITE PRO Up to 1.0 IU/mL
ACL Futura/
ACL Advance Up to 1.0 IU/mL
ACL TOP Family Up to 1.1 IU/mL | UFH Low | 0.41 | 4.4 | 4.4 |
| Characteristic | New Device:
HemosIL Heparin Calibrators | Predicate Device:
Calibration Plasma LMW Heparin
(K030964) | UFH High | 0.69 | 1.3 | 1.7 |
| Intended Use | For the calibration of the HemosIL Liquid
Heparin assay on IL Coagulation Systems
(ACL TOP® Family, ACL™ ELITE/ELITE
PRO®/8/9/10000 and ACL Futura/ACL
Advance Systems). | For preparation of calibration curves for
use in chromogenic heparin assays. | LMWH Low | 0.56 | 2.5 | 3.5 |
| Form | Lyophilized | Same | LMWH High | 1.37 | 1.1 | 1.6 |
| Characteristic | New Devices (Sold Separately):
HemosIL LMW Heparin Controls
HemosIL UF Heparin Controls | Predicate Device:
Control Plasma LMW Heparin
(K030965) | ACL TOP Family | Mean (IU/mL) | CV % (Within run) | CV % (Total) |
| Intended Use | LMWH Controls: For the quality control of
the HemosIL Liquid Heparin assay when
testing for low molecular weight heparin
(LMW) on IL Coagulation Systems (ACL
TOP® Family, ACL™ ELITE/ELITE
PRO®/8/9/10000 and ACL Futura/ACL
Advance Systems).
UFH Controls: For the quality control of the
HemosIL Liquid Heparin assay when
testing for unfractionated heparin (UFH) on
IL Coagulation Systems. | For the quality control of chromogenic
heparin assays. | UFH Low | 0.41 | 2.4 | 3.3 |
| UFH High | 0.68 | 1.0 | 1.6 | | | |
| LMWH Low | 0.55 | 3.5 | 4.5 | | | |
| LMWH High | 1.35 | 1.9 | 2.5 | | | |
K090209 -- HemosIL Liquid Heparin Assay, Controls and Calibrators Attachment G
…
·
Page 3 of 4
3
510(k) Summary (Cont.)
Summary Performance Data:
. . . .
Precision
Precision was assessed over multiple runs using the two levels of both UFH and LMWH Controls on representative IL Coagulation Systems:
Method Comparison - In-house
An in-house method comparison study was performed, using samples from patients undergoing heparin therapy, to compare the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:
| IL System | n | Slope | r |
|---|---|---|---|
| ACL ELITE | 124 | 0.894 | 0.907 |
| ACL Advance | 152 | 1.067 | 0.946 |
| ACL TOP | 148 | 0.946 | 0.958 |
Method Comparison - Field Sites
Three field site studies were performed, using samples from patients undergoing heparin therapy, Thee note the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:
| IL System | n | Slope | r |
|---|---|---|---|
| ACL ELITE | 114 | 1.032 | 0.949 |
| ACL Advance | 111 | 1.007 | 0.957 |
| ACL TOP | 81 | 0.952 | 0.978 |
Attachment G
K090209 -- HemosIL Liquid Heparin Assay, Controls and Calibrators
Page 4 of 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Instrumentation Laboratory Co. c/o Ms. Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
JUN - 2 2009
Re: K090209
Trade/Device Name: HemosIL Liquid Heparin, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls and HemosIL UF Heparin Controls
Regulation Number: 21 CFR §864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF, JIS, GGN Dated: April 23, 2009 Received: April 24, 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 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); medical device reporting (reporting of
5
Page 2 - Ms. Carol Marble
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
m. Clan
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
Ko90209 510(k) Number (if known):
Device Name:
HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL LMW Heparin Controls HemosIL UF Heparin Controls
Indications for Use:
- HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination . of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on t IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ELITE PRO® 8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
- HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
For in vitro diagnostic use.
ﮯ Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 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)
ie M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090209
Section 4
HemosIL Liquid Heparin Kit, Calibrators and Controls 510(k)
Page 1 of 1