(344 days)
Not Found
No
The device description and performance studies focus on a chromogenic assay and standard statistical analysis, with no mention of AI or ML techniques.
No
This device is an in vitro diagnostic assay used to measure heparin activity in patient plasma, which helps monitor anticoagulant therapy. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "In vitro diagnostic automated chromogenic assay." Additionally, it is used for the "quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity in human plasma... For use with plasma from patients undergoing heparin anticoagulant therapy," which is a diagnostic application to monitor patient treatment.
No
The device is an in vitro diagnostic assay kit consisting of reagents and calibrators, which are physical components used in a laboratory setting with a coagulation analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples... in the clinical laboratory." This clearly indicates the device is intended for use outside of the body to diagnose or provide information about a patient's health status.
- Sample Type: The assay is performed on "human plasma collected from venous blood samples," which is a biological specimen taken from the body.
- Purpose: The purpose is the "quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity," which provides information about the presence and level of these substances in the patient's blood, relevant to their medical treatment (heparin anticoagulant therapy).
- Setting: The intended use is in the "clinical laboratory," a typical setting for IVD testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INNOVANCE® Heparin Assay
In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations.
INNOVANCE® Heparin Calibrator
For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
INNOVANCE® Heparin UF and LMW Controls
For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
Product codes (comma separated list FDA assigned to the subject device)
KFF, JIS, GGN
Device Description
The INNOVANCE® Heparin assay is a one stage chromogenic assay. The reagent kit consists of two components. One component (INNOVANCE Heparin Reagent) contains Coagulation Factor Xa (Xa), the other (INNOVANCE Heparin Substrate) a chromogenic substrate specific for Xa. Upon mixing of INNOVANCE Heparin Reagent and INNOVANCE Heparin Substrate, Xa converts the chromogenic substrate into two products, one of them is paranitroaniline. The formation of paranitroaniline can be quantified by the coaqulation analyzer employing light absorption at a specific wavelength (405 nm). In the presence of a heparin containing sample the formation of paranitroaniline will be reduced in a time dependent manner. This is due to inhibition of Xa by the heparin/antithrombin (AT) complex. This complex is formed in the patient's plasma and competes with the substrate conversion by Xa. The concentration of the complex is not only dependent on the concentration of heparin but also on the availability of the patient's endogenous antithrombin. By comparison to a reference curve the heparin activity of the sample can be quantified. To reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.
The INNOVANCE® Heparin Calibrator consists of 5 calibrator levels. INNOVANCE® Heparin Calibrator 1 represents plasma containing no heparin. INNOVANCE® Heparin Calibrator 2, 3, 4 and 5 contain defined activities of LMWH and are calibrated against the World Health Orqanization (WHO) International Standards for UFH and LMWH. The calibrator levels are used to establish a reference curve (calibration curve) which then can be employed to quantify the heparin activity of UFH and LMWH containing plasmas.
The INNOVANCE® Heparin Controls consist of plasmas containing defined activities of either UFH or LMWH. Recovery of these controls within their assigned ranges indicates proper functionality of the assay system.
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
The performance of this device has not been established in neonate and pediatric patient populations.
Intended User / Care Setting
clinical laboratory.
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)
Non-Clinical Studies
Measuring Range (Linearity and LoQ):
The analytical measuring range of the INNOVANCE Heparin assay was confirmed by establishment of the Limit of Quantitation (LoQ) for the low end and by a linearity study. The linearity study was performed by using normal plasma (pool) spiked with increasing activities (0.00 to 1.90 IU/mL) of the International Standard for Unfractionated Heparin (IS UFH) and normal plasma (pool spiked with increasing activities (0.00 to 1.90 IU/mL) of the International Standard for Low Molecular Weight Heparin (IS LMWH). Plasma pools containing no heparin were spiked with each respective heparin (UFH and LMWH) to equal 21 different dilutions per heparin with 3 lots of reagents. The testing was in accordance with CLSI: EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guide/ine in which the mean of four replicates from each dilution were plotted versus the assigned values. Differences between the predicted value from the best fitting polynomial and the predicted value from the 1st order regression were calculated for each dilution level for each heparin type. Based on the results of these two studies, the assay range for the INNOVANCE Heparin assay was established as 0.10 - 1.50 IU/mL.
Specificity:
Interference testing was performed according to CLSI: EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. Testing included endogenous interferents (bilirubin (unconiuqated), bilirubin (coniuqated), hemoglobin, platelet factor 4 (PF4) and triglycerides), known exogenous interferents (Rivaroxaban, Apixaban, Fondaparinux, Danaparoid Sodium) and other Over the Counter and Prescription drugs. Base pools of UFH and LMWH were prepared to span the assay range and to cover medical decision points and these base pools were used to perform the interference testing. Information about interference will be included in the Instructions for Use for INNOVANCE Heparin and in the application sheet.
Results: No interference up to indicated concentrations for Ascorbic Acid (176 mg/dL), Bilirubin (unconjugated) (60 mg/dL), Bilirubin (conjugated) (40 mg/dL), Hemoglobin (347 mg/dL), Platelet Factor 4 (0.7 μg/mL), Triglycerides (807 mg/dL), Rheumatoid Factor (220 IU/mL), Apixaban (4.1 ng/mL), Danaparoid Sodium (0.03 IU/mL), Fondaparinux (35.5 ng/mL), Rivaroxaban (7.1 ng/mL).
Clinical Studies
Reproducibility and Repeatability Studies:
A multicenter reproducibility study was performed in accordance with CLSI: EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline-Second Edition with the INNOVANCE® Heparin assay on the BCS® XP System. The study was conducted at three external sites for both UFH and LMWH. Plasma pools spanning the assay range were prepared at the Siemens Marburg site and sent frozen to the external study sites for testing along with appropriate controls for LMWH and UFH. For reagent repeatability study, the testing data of the three lots at one site (Bad Oeynhausen) of INNOVANCE® Heparin reagent with LMWH/UFH controls (level 1 and 2) and heparin plasma pool samples was included.
Results for INNOVANCE® Heparin Reagent Reproducibility Study (N=240 per sample, 3 sites): Total CV ranged from 2.97% to 21.15% for LMW samples and 3.29% to 20.60% for UF samples.
Results for INNOVANCE® Heparin Reagent Repeatability Study (N=239-240 per sample, 1 site, 3 lots): Total CV ranged from 1.85% to 9.30% for LMW samples and 3.21% to 7.58% for UF samples.
Results for INNOVANCE® Heparin Calibrator Reproducibility Study (N=120 per sample, 3 sites): Total CV ranged from 2.23% to 3.36%.
Results for INNOVANCE® Heparin Calibrator Repeatability Study (N=240 per sample, 1 site, 3 lots): Total CV ranged from 2.53% to 3.74%.
Results for INNOVANCE® Heparin Control Reproducibility Study (N=240 per sample, 3 sites): Total CV ranged from 2.97% to 7.30%.
Results for INNOVANCE® Heparin Control Repeatability Study (N=240 per sample, 1 site, 3 lots): Total CV ranged from 2.45% to 3.67%.
Frozen vs. Fresh Method Comparison Study:
The objective of this study was to perform a method comparison study to confirm comparability of results obtained when using either fresh or frozen samples. Sample size: a minimum of 60 samples. Data source: one study site in Germany. One reagent lot was used. Fresh samples were measured within four (4h) after blood collection. Aliquots were stored at -70°C for a minimum of one week. Thawed aliquots were measured immediately within two (2) hours. Results were analyzed by both Passing-Bablok regression analysis and Bland Altman analysis.
Results: N=69. Slope=1.00, Intercept=-0.01 IU/mL, r=0.996, r2=0.993. Predicted Bias at 0.3 IU/mL and 0.4 IU/mL was -0.01 IU/mL. Predicted Bias at 0.6 IU/mL was -1.67%, 0.7 IU/mL was -1.43%, and 1.0 IU/mL was -1.00%. All acceptance criteria were met.
Method comparison:
Method comparison studies designed according to CLSI: EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition and were conducted at three sites including one external US site. Frozen samples were thawed and measured on both the predicate device, Coamatic® Heparin assay on the ACL TOP, as well as the new device, INNOVANCE® Heparin assay on the BCS® XP, in random order. Results from all sites combined were compared by Passing-Bablok regression analysis.
Results:
INNOVANCE® Heparin on BCS® XP System vs. Coamatic® Heparin on ACL TOP System (UFH samples only): N=165, Slope=0.93, Intercept=0.03, Correlation Coefficient (r)=0.98.
INNOVANCE® Heparin on BCS® XP System vs. Coamatic® Heparin on ACL TOP System (LMWH samples only): N=155, Slope=1.06, Intercept=-0.01, Correlation Coefficient (r)=0.99.
Results met the pre-established acceptance criteria for slope, intercept and correlation coefficient.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
Siemens Healthcare Diagnostics Products GmbH Rose Marinelli Regulatory Clinical Affairs Specialist Emil-von-Behring Str 76 Marburg, Germany 35041
Re: K162540 Trade/Device Name: INNOVANCE® Heparin Assay INNOVANCE® Heparin Calibrator INNOVANCE® Heparin UF and LMW Controls Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin assay Regulatory Class: Class II Product Code: KFF, JIS, GGN Dated: August 10, 2017 Received: August 14, 2017
Dear Ms. Marinelli:
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. 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
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800)638-2041 or (301)796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou /Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/ Industry/default.htm.
Sincerely.
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162540
Device Name INNOVANCE® Heparin Assay INNOVANCE® Heparin Calibrator INNOVANCE® Heparin UF and LMW Controls
Indications for Use (Describe)
INNOVANCE® Heparin Assay
In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations.
INNOVANCE® Heparin Calibrator
For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
INNOVANCE® Heparin UF and LMW Controls
For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and follows the FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", issued July 28, 2014.
1 Submitter
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany
| Contact Person: | Rose Marinelli |
|---|---|
| Email: | rose.t.marinelli@siemens-healthineers.com |
| Phone: | 302-631-8805 |
| Facsimile: | 302-631-6299 |
| Date: | Prepared: September 9, 2016 |
2 Device
| Name of Device: | INNOVANCE® Heparin Assay |
|---|---|
| Common or Usual Name: | Heparin |
| Classification Name: | Heparin assay (21 CFR 864.7525) |
| Regulatory Class: | Class II |
| Product Code: | KFF |
| 510(k) Review Panel: | Hematology |
| Name of Device: | INNOVANCE® Heparin Calibrator |
| Common or Usual Name: | Calibrator, primary |
| Classification Name: | Calibrator (21 CFR 862.1150) |
| Regulatory Class: | Class II |
| Product Code: | JIS |
| 510(k) Review Panel: | Hematology |
| Name of Device: | INNOVANCE® Heparin UF and LMW Controls INNOVANCE® Heparin UF Control 1 INNOVANCE® Heparin UF Control 2 INNOVANCE® Heparin LMW Control 1 INNOVANCE® Heparin LMW Control 2 |
| Common or Usual Name: | Heparin Controls |
| Classification Name: | Plasma, Coagulation Control |
| (21 CFR 864.5425) |
4
| Regulatory Class: | Class II |
|---|---|
| Product Code: | GGN |
| 510(k) Review Panel: | Hematology |
3 Predicate Device
Coamatic Heparin Assay, K983178 (UFH and LMWH)
A method comparison study for the above listed device was performed with the Coamatic Heparin assay on the Instrumentation Laboratory (IL) ACL TOP®. To the best of our knowledge, the predicate device has not been subject to a design-related recall for any of the applications associated with this Premarket Notification.
4 Device Description / Test Principle
The INNOVANCE® Heparin assay is a one stage chromogenic assay. The reagent kit consists of two components. One component (INNOVANCE Heparin Reagent) contains Coagulation Factor Xa (Xa), the other (INNOVANCE Heparin Substrate) a chromogenic substrate specific for Xa. Upon mixing of INNOVANCE Heparin Reagent and INNOVANCE Heparin Substrate, Xa converts the chromogenic substrate into two products, one of them is paranitroaniline. The formation of paranitroaniline can be quantified by the coaqulation analyzer employing light absorption at a specific wavelength (405 nm). In the presence of a heparin containing sample the formation of paranitroaniline will be reduced in a time dependent manner. This is due to inhibition of Xa by the heparin/antithrombin (AT) complex. This complex is formed in the patient's plasma and competes with the substrate conversion by Xa. The concentration of the complex is not only dependent on the concentration of heparin but also on the availability of the patient's endogenous antithrombin. By comparison to a reference curve the heparin activity of the sample can be quantified. To reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.
The INNOVANCE® Heparin Calibrator consists of 5 calibrator levels. INNOVANCE® Heparin Calibrator 1 represents plasma containing no heparin. INNOVANCE® Heparin Calibrator 2, 3, 4 and 5 contain defined activities of LMWH and are calibrated against the World Health Orqanization (WHO) International Standards for UFH and LMWH. The calibrator levels are used to establish a reference curve (calibration curve) which then can be employed to quantify the heparin activity of UFH and LMWH containing plasmas.
The INNOVANCE® Heparin Controls consist of plasmas containing defined activities of either UFH or LMWH. Recovery of these controls within their assigned ranges indicates proper functionality of the assay system.
5 Intended Use / Indications for Use
INNOVANCE® Heparin Assay
In-vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2 % sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations.
5
INNOVANCE® Heparin Calibrator
For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
INNOVANCE® Heparin UF and LMW Controls
For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.
Comparison of Technological Characteristics 6
| ltem | Proposed Device
INNOVANCE® Heparin Assay | Predicate Device
Coamatic Heparin - K983178 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Intended Use | In-vitro diagnostic automated
chromogenic assay for the quantitative
determination of unfractionated heparin
(UFH) and low molecular weight heparin
(LMWH) activity in human plasma
collected from venous blood samples in
3.2% sodium citrate tubes on the BCS®
XP System in the clinical laboratory. | For the quantitative determination of
unfractionated heparin (UF Heparin) or
low molecular weight heparin (LMW
Heparin) in human citrated plasma using
automated and microplate methods. |
| Indications for
Use | For use with plasma from patients
undergoing heparin anticoagulant therapy
with either UFH or LMWH. | Not available from package insert. |
| Heparin Type | UFH and LMWH | Same |
| Test Principle | Chromogenic | Same |
| Sample Type | 3.2% Citrated human plasma | Same |
| Antithrombin | None | Same |
| Control Level | 2 levels for UFH and 2 levels for LMWH | Same |
6.1 Comparison of Reagent Features
6
| Item | Proposed Device
INNOVANCE® Heparin Assay | Predicate Device
Coamatic Heparin – K983178 |
|---------------------------|----------------------------------------------------------------------|------------------------------------------------|
| Units | IU/mL | Same |
| Storage | Until expiration date printed on each vial
and carton at 2 - 8 °C | Same |
| Measuring
Range | 0.10 to 1.50 IU/mL | 0 to 1.5 IU/mL |
| Composition | Liquid
(Factor Xa and chromogenic substrate) | Lyophilized
(Factor Xa and S-2732) |
| Calibration
Curve | Single calibration curve for UFH and
LMWH | Same |
| Stability / Shelf
Life | 24 months at 2-8 °C | Not available from package insert |
| Stability once
opened | 8 weeks at 2-8 °C | 3 months at 2-8 °C in the original vial |
| On Board
Stability | 24 hours in cooled positions on the
BCS® XP System | Not available from package insert. |
6.2 Comparison of Calibrator Features
| Item | Proposed Device
INNOVANCE® Heparin Calibrator | Predicate Device
3rd International Standard for LMWH
6th International Standard for UFH |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | For the calibration of the
INNOVANCE® Heparin assay for the
quantitative determination of the
activity of unfractionated heparin
(UFH) and low molecular weight
heparin (LMWH) in citrated human
plasma. | International Standard for LMWH
International Standard for UFH |
| Matrix | Human Plasma (Lyophilized) | Porcine Mucosa |
| Components | LMWH | UFH and LMWH |
| Traceability to WHO | Yes | WHO Standard |
| On-Board Stability | 4 Hours (BCS XP) | Not Available |
| Shelf-life | 24 Months at 2-8°C | LMWH: 6 months at -40°C or below
UFH: Not available |
7
| Stability after
Reconstitution | 24 hours at 15-25 °C
48 hours at 2-8 °C | Not available |
|-----------------------------------|--------------------------------------------|-------------------------------------------------------------------|
| Calibrator Levels | 5 levels | 1 level; to be reconstituted and diluted
in plasma, as needed. |
6.3 Comparison of Control Features
| Item | Device (K162540)
INNOVANCE Heparin UF and LMW
Controls | Coamatic Heparin Control |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Intended Use | For quality control of the
INNOVANCE® Heparin assay for the
quantitative determination of the activity
of unfractionated heparin (UFH) and
low molecular weight heparin (LMWH)
in citrated human plasma. | Not Available |
| Matrix | Human Plasma (Lyophilized) | Not Available |
| Traceability to WHO | Yes | Not Available |
| Number of Control | 2 levels for LMWH
2 levels for UFH | Not Available |
| Reconstitution
Stability | 24 hours at 15-25°C
48 hours at 2-8ºC
4 weeks at