(341 days)
Not Found
No
The device description details a chromogenic assay based on chemical reactions and optical measurements. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for AI/ML mentions and training/test data.
No.
This device is an in vitro diagnostic assay used to measure levels of heparin and apixaban in human plasma, which helps laboratory professionals monitor drug levels. It does not directly treat or diagnose a disease state within a patient.
Yes
The device is an "automated chromogenic assay for in vitro diagnostic use." It provides quantitative results for various analytes to help laboratory professionals assess patient conditions, such as determining heparin or apixaban levels for patients at risk of bleeding or experiencing a bleeding episode. This functionality clearly falls under the definition of a diagnostic device.
No
The device description clearly states it is a "one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation," which are physical reagents and a chemical process, not software. It also mentions being used on specific hardware platforms (ACL TOP Family and ACL TOP Family 50 Series).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories."
This statement clearly identifies the device as intended for use in examining specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
- · When used with HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
- · When used with HemosIL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
KFF, QLU
Device Description
HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
. When used with HemosIL Heparin Calibrators:
Heparin levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Heparin Calibrators.
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 heparinantithrombin 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.
In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.
When used with HemosIL Apixaban Calibrators: .
Apixaban levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Apixaban Calibrators.
Apixaban directly inhibits Factor Xa activity independent of the antithrombin present. The Factor Xa activity measured by the assay is exogenous. Factor Xa is neutralized directly by apixaban.
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 apixaban level in the sample.
Measurement of apixaban concentration is recommended by the International Society of Thrombosis and Hemostasis Subcommittee on Control of Anticoagulation in certain clinical scenarios including bleeding episodes, perioperative management, and suspicion of overdose.
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
adult population
Intended User / Care Setting
laboratory professionals in clinical laboratories.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOD (Limit of Detection):
Heparin: 0.04 IU/mL
Apixaban: 9 ng/mL
Linearity:
Heparin: Up to 2 IU/mL
Apixaban: 20 ng/mL – 1000 ng/mL
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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2022
Instrumentation Laboratory Co. Carol Marble Sr. Regulatory Affairs Director 180 Hartwell Road Bedford, Massachusetts 01730
Re: K213464
Trade/Device Name: HemosIL Liquid Anti-Xa Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF, QLU Dated: June 3, 2022 Received: June 6, 2022
Dear Carol Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name HemosIL Liquid Anti-Xa
Indications for Use (Describe)
HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
- · When used with HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
- · When used with HemosIL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
Image /page/3/Picture/0 description: The image shows the logo for Instrumentation Laboratory, a Werfen Company. The logo consists of a stylized graphic of two overlapping shapes in green and blue, followed by the company name in a dark gray sans-serif font. Below the company name, in a smaller font, is the text "A Werfen Company."
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory Company
180 Hartwell Road
Bedford, MA 01730-2443 (USA) |
| ------------------------- | ----------------------------------------------------------------------------------------- |
|---|
| Contact Person | Carol Marble
Senior Director of Quality Assurance and Regulatory Affairs |
|----------------|-----------------------------------------------------------------------------|
| | Phone: 781-861-4467 |
| | Fax: 781-861-4207 |
| | Email: cmarble@werfen.com |
| Preparation Date | June, 2022 |
|---|---|
| ------------------ | ------------ |
| Device Trade Name | HemosIL Liquid Anti-Xa |
|---|---|
| ------------------- | ------------------------ |
| Predicate Device | HemosIL Liquid Anti-Xa | K090209, DEN190032 |
|---|---|---|
| ------------------ | ------------------------ | -------------------- |
| Regulatory Information | ||||||||
|---|---|---|---|---|---|---|---|---|
| Analyte | Regulation | |||||||
| Section | Regulatory Description | Class | Product | |||||
| Code | Panel | |||||||
| Heparin | 864.7525 | Heparin Assay | II | KFF | 81 | |||
| Apixaban | 864.7295 | Anti-factor Xa Activity Test System, Apixaban | II | QLU |
4
Device Description
HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
. When used with HemosIL Heparin Calibrators:
Heparin levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Heparin Calibrators.
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 heparinantithrombin 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.
In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.
When used with HemosIL Apixaban Calibrators: .
Apixaban levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Apixaban Calibrators.
Apixaban directly inhibits Factor Xa activity independent of the antithrombin present. The Factor Xa activity measured by the assay is exogenous. Factor Xa is neutralized directly by apixaban.
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 apixaban level in the sample.
Measurement of apixaban concentration is recommended by the International Society of Thrombosis and Hemostasis Subcommittee on Control of Anticoagulation in certain clinical scenarios including bleeding episodes, perioperative management, and suspicion of overdose.
5
Indications for Use / Intended Use
HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
When used with HemosIL Heparin Calibrators: .
Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
. When used with HemosIL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:
- -Patients at risk for major bleeding
- -Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only.
Reason for Submission
This Special 510(k) is being submitted to modify the labeled on-board instrument stability claims for HemosIL Liquid Anti-Xa on the ACL TOP Family and ACL TOP Family 50 Series from 7 days to 4 days for heparin and apixaban based on testing to the current CLSI EP25-A guideline. This submission also removes claims for heparin measurement on the ACL Elite/Elite Pro instrument family from the HemosIL Liquid Anti-Xa labeling.
The submission meets the criteria for a Special 510(k) based on the following:
- The proposed changes are submitted by the manufacturer legally authorized to market the existing . device.
- There is a well-established method to evaluate the change: CLSI EP25-A.
- The data can be reviewed in a summary or risk analysis format. ●
In addition, the changes in this submission do not introduce:
- . Changes to indications for use or intended use, except to remove the ACL Elite/Elite Pro instrument family
- Changes to operating principle ●
- Changes to formulation ●
- Changes to labeled performance claims, except to reduce the on-board instrument stability claims for ● the ACL TOP Family/ACL TOP Family 50 Series to 4 days for heparin and apixaban and to remove all claims for heparin measurement with the ACL Elite/Elite Pro instrument family
6
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate Device | |
| [K090209 (heparin), DEN190032 (apixaban)] | Subject Device | |
| Similarities | ||
| Trade Name | HemosIL Liquid Anti-Xa | Same |
| Manufacturer | Instrumentation Laboratory Company | Same |
| Intended Use/ | ||
| Indications for | ||
| Use | ||
| (Changes in Blue | ||
| and | ||
| Strikethrough) | HemosIL Liquid Anti-Xa is an automated chromogenic assay for | |
| in vitro diagnostic use by laboratory professionals in clinical | ||
| laboratories. The assay provides quantitative results on 3.2% | ||
| citrated human plasma for the following analytes based on the | ||
| calibrators used: |
When used with HemosIL Heparin Calibrators:
Quantitative determination of unfractionated heparin (UFH)
and low molecular weight heparin (LMWH) activity on the
ACL TOP Family, and ACL TOP Family 50 Series, and
ACL Elite/Elite Pro. When used with HemosIL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP
Family and ACL TOP Family 50 Series through
measurement of Factor Xa activity, which is inversely
proportional to the apixaban level. With HemosIL Apixaban
Calibrators, the assay is intended to measure apixaban
concentrations in patients on apixaban therapy in the
following situations where measurement of apixaban levels
could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode The assay is not a stand-alone test and the results should be used
in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only. | Same, except
for removal of
ACL Elite/Elite
Pro instrument
family |
| Comparison to Predicate | | |
| Item | Predicate Device
[K090209 (heparin), DEN190032 (apixaban)] | Subject Device |
| Similarities (Cont.) | | |
| Test Principle | One stage chromogenic assay based on a synthetic
chromogenic substrate and on factor Xa inactivation | Same |
| Sample Type | 3.2% Citrated Plasma | Same |
| Measurement | Quantitative | Same |
| Reporting Units | Heparin
IU/mL | Same |
| | Apixaban
ng/mL | |
| Quality Control | Automated QC | Same |
| Limit of Detection | Heparin
0.04 IU/mL | Same |
| | Apixaban
9 ng/mL | |
| Linearity | Heparin
Up to 2 IU/mL | Same |
| | Apixaban
20 ng/mL – 1000 ng/mL | |
7
| Item | Predicate Device
[K090209 (heparin),
DEN190032 (apixaban)] | Subject Device |
|-----------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Instrumentation | ACL TOP Family (K160276)
ACL TOP Family 50 Series (K150877)
ACL Elite/Elite Pro (K060162) | ACL TOP Family (K160276)
ACL TOP Family 50 Series (K150877)
Note: ACL Elite/Elite Pro claims removed |
| On-Board
Stability | 7 days at 15-25°C on the ACL TOP
Family/ACL TOP Family 50 Series for
heparin and apixaban | 4 days at 15-25°C on the ACL TOP
Family/ACL TOP Family 50 Series for
heparin and apixaban |