HemosIL Factor XII Deficient Plasma

K180486 · Instrumentation Laboratory CO · GJT · Mar 22, 2018 · Hematology

Device Facts

• Record ID: K180486
• Device Name: HemosIL Factor XII Deficient Plasma
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Mar 22, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

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.

Device Story

HemosIL Factor XII Deficient Plasma; artificially depleted plasma; used for quantitative determination of Factor XII activity in human citrated plasma via clotting method. Operates on ACL TOP Family and ACL TOP Family 50 Series coagulation systems. Modification involves updating recommended on-board stability from 24 hours to 6 hours at 15°C. Used in clinical laboratory settings by trained personnel. Output provides Factor XII activity levels to assist in coagulation disorder diagnosis and management.

Clinical Evidence

Bench testing only. Verification testing conducted in accordance with CLSI EP25-A to establish the modified on-board instrument stability claim.

Technological Characteristics

Human plasma immunodepleted of factor XII. Functional clotting assay (APTT). Compatible with ACL TOP Family and ACL TOP Family 50 Series coagulation analyzers. No changes to formulation, materials, or data reduction software.

Indications for Use

Indicated for the quantitative determination of Factor XII activity in human citrated plasma using the clotting method on IL Coagulation Systems.

Predicate Devices

• HemosIL Factor XII Deficient Plasma (K043459)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> <span></span> 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.<br>180 Hartwell Road<br>Bedford, MA 01730, USA | |
| Contact Person | Carol Marble, Regulatory Affairs Director<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| 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<br>a modified activated partial thromboplastin time test (APTT).<br>Patient plasma is diluted and added to plasma deficient in factor XII.<br>Correction of the clotting time of the deficient plasma is<br>proportional to the concentration (% activity) of that factor in the<br>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. | |

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| Indications for Use | HemosIL Factor XII Deficient Plasma is human plasma<br>immunodepleted of factor XII and intended for the <i>in vitro</i><br>diagnostic quantitative determination of factor XII activity in<br>citrated plasma, based on the activated partial thromboplastin<br>time (APTT) assay, on IL Coagulation Systems. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Description of the Modification | The on-board instrument claim in the HemosIL Factor XII Deficient<br>Plasma insert sheet is being updated as follows based on additional<br>testing done to current CLSI EP25-A requirements. | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Current Claim: 24 Hours | Modified Claim: 6 Hours |

| Reason Submission<br>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<br>instrument stability claim for HemosIL Factor XII Deficient Plasma<br>was conducted under design control and in accordance with CLSI<br>EP25-A. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Comparison to Predicate | | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Similarities | | |
| Item | Predicate (K043459) | Modified Device |
| Intended Use | Human plasma immunodepleted of factor XII<br>for the quantitative determination of factor XII<br>(FXII) activity in citrated plasma, based on<br>activated partial thromboplastin time (APTT)<br>assay, on IL Coagulation Systems. | Same |
| Indications for Use | HemosIL Factor XII Deficient Plasma is human<br>plasma immunodepleted of factor XII and<br>intended for the <i>in vitro</i> diagnostic<br>quantitative determination of factor XII<br>activity in citrated plasma, based on the<br>activated partial thromboplastin time (APTT)<br>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<br>are determined by performing a modified<br>activated partial thromboplastin time (APTT)<br>test. Patient plasma is diluted and added to<br>plasma deficient in factor XII. Correction of the<br>clotting time of the deficient plasma is<br>proportional to the concentration (% activity)<br>of factor XII in the patient plasma,<br>interpolated from a calibration curve. | Same |
| Sample Type | Citrated Plasma | Same |
| On-Board Instrument<br>Stability with<br>Following Analyzers | ACL TOP Family:<br>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<br>plasma share the same Intended Use/ Indications for Use, same test<br>principle, same formulation and the same performance characteristics,<br>except for the updated on-board instrument claim for the ACL TOP Family<br>and ACL TOP Family 50 Series. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Therefore, HemosIL Factor XII Deficient Plasma with an updated on-board<br>instrument claim is substantially equivalent to the currently marketed<br>predicate device that is FDA cleared under K043459. |