(27 days)
Not Found
No
The description details a standard in vitro diagnostic assay based on a modified APTT test and a calibration curve, with no mention of AI or ML techniques.
No
The device is an in vitro diagnostic (IVD) product used for the quantitative determination of factor XII activity in plasma. It is not intended for treating or preventing diseases or conditions in patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of factor XII activity."
No
The device is a reagent (plasma) used in an in vitro diagnostic test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma". This clearly indicates the device is used outside of the body to diagnose or monitor a condition.
- Device Description: The description details a laboratory test performed on a patient's plasma sample ("Patient plasma is diluted and added to plasma deficient in factor XII"). This is characteristic of an in vitro diagnostic test.
- Name: The name "HemosIL Factor XII Deficient Plasma" suggests a reagent used in a laboratory setting for blood analysis.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL Factor XII Deficient Plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.
Product codes
GJT
Device Description
Factor XII activity in a patient's plasma is determined by performing a modified activated partial thromboplastin time test (APTT). Patient plasma is diluted and added to plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of that factor in the patient plasma, interpolated from a calibration curve.
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)
The verification testing to establish the modified on-board instrument stability claim for HemosIL Factor XII Deficient Plasma was conducted under design control and in accordance with CLSI EP25-A.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 22, 2018
Instrumentation Laboratory Co. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, Massachusetts 01730
Re: K180486
Trade/Device Name: HemosIL Factor XII Deficient Plasma Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GJT Dated: February 22, 2018 Received: February 23, 2018
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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Indications for Use
510(k) Number (if known) K180486
Device Name HemosIL Factor XII Deficient Plasma
Indications for Use (Describe)
HemosIL Factor XII Deficient Plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.
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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510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CER 807.92 and the Safe Medical Device Act of 1990.
| Submission Type | Special 510(k) | |
|---|---|---|
| Submitter's Information | Instrumentation Laboratory (IL) Co. | |
| 180 Hartwell Road | ||
| Bedford, MA 01730, USA | ||
| Contact Person | Carol Marble, Regulatory Affairs Director | |
| Phone: 781-861-4467 | ||
| Fax: 781-861-4207 | ||
| Email: cmarble@ilww.com | ||
| Preparation Date | February 22, 2018 | |
| Device Trade Name | HemosIL Factor XII Deficient Plasma | |
| Regulatory Information | Regulation Number | 21 CFR 864.7290 |
| Regulation Description | Factor Deficiency Test | |
| Classification | Class II | |
| Product Code | GJT | |
| Classification Panel | Hematology (81) | |
| Predicate Device | K043459 | HemosIL Factor XII Deficient Plasma |
| Device Description | Factor XII activity in a patient's plasma is determined by performing | |
| a modified activated partial thromboplastin time test (APTT). | ||
| Patient plasma is diluted and added to plasma deficient in factor XII. | ||
| Correction of the clotting time of the deficient plasma is | ||
| proportional to the concentration (% activity) of that factor in the | ||
| patient plasma, interpolated from a calibration curve. | ||
| Intended Use | Human plasma immunodepleted of factor XII for the quantitative determination of factor XII (FXII) activity in citrated plasma, based on activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems. |
4
| Indications for Use | HemosIL Factor XII Deficient Plasma is human plasma
immunodepleted of factor XII and intended for the in vitro
diagnostic quantitative determination of factor XII activity in
citrated plasma, based on the activated partial thromboplastin
time (APTT) assay, on IL Coagulation Systems. |
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Description of the Modification | The on-board instrument claim in the HemosIL Factor XII Deficient
Plasma insert sheet is being updated as follows based on additional
testing done to current CLSI EP25-A requirements. | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Current Claim: 24 Hours | Modified Claim: 6 Hours |
| Reason Submission
| Qualifies as Special 510(k) | The submission meets the criteria for a Special 510(k) based on the following: |
|---|---|
| • No change in indications for use or intended use | |
| • No change in operating principle | |
| • No change to performance claims, except for the on-board stability | |
| • No change to reagent preparation | |
| • No change to specimen collection and preparation | |
| • No change to formulation or materials | |
| • No change to data reduction software | |
| • No change to calibration | |
| • No change to quality controls |
| Design Control Activities | The verification testing to establish the modified on-board
instrument stability claim for HemosIL Factor XII Deficient Plasma
was conducted under design control and in accordance with CLSI
EP25-A. |
| --------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| Comparison to Predicate | ||
|---|---|---|
| Similarities | ||
| Item | Predicate (K043459) | Modified Device |
| Intended Use | Human plasma immunodepleted of factor XII | |
| for the quantitative determination of factor XII | ||
| (FXII) activity in citrated plasma, based on | ||
| activated partial thromboplastin time (APTT) | ||
| assay, on IL Coagulation Systems. | Same | |
| Indications for Use | HemosIL Factor XII Deficient Plasma is human | |
| plasma immunodepleted of factor XII and | ||
| intended for the in vitro diagnostic | ||
| quantitative determination of factor XII | ||
| activity in citrated plasma, based on the | ||
| activated partial thromboplastin time (APTT) | ||
| assay, on IL Coagulation Systems. | Same | |
| Measurand | Factor XII Activity | Same |
| Type of Test | Functional Clotting Assay | Same |
| Methodology | Abnormalities of the intrinsic pathway factors | |
| are determined by performing a modified | ||
| activated partial thromboplastin time (APTT) | ||
| test. Patient plasma is diluted and added to | ||
| plasma deficient in factor XII. Correction of the | ||
| clotting time of the deficient plasma is | ||
| proportional to the concentration (% activity) | ||
| of factor XII in the patient plasma, | ||
| interpolated from a calibration curve. | Same | |
| Sample Type | Citrated Plasma | Same |
| On-Board Instrument | ||
| Stability with | ||
| Following Analyzers | ACL TOP Family: | |
| ACL TOP 300 CTS ACL TOP 500 CTS ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP Family 50 Series: ACL TOP 350 CTS ACL TOP 550 CTS ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS | Same | |
| Expected Value Range | 50-150% (0.50-1.50 IU/mL) | Same |
| Differences | ||
| On-Board Claim | 24 Hours | 6 Hours |
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| Conclusion | HemosIL Factor XII Deficient Plasma and the currently marketed deficient
plasma share the same Intended Use/ Indications for Use, same test
principle, same formulation and the same performance characteristics,
except for the updated on-board instrument claim for the ACL TOP Family
and ACL TOP Family 50 Series. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Therefore, HemosIL Factor XII Deficient Plasma with an updated on-board
instrument claim is substantially equivalent to the currently marketed
predicate device that is FDA cleared under K043459. |