HemosIL Silica Clotting Time

K160445 · Instrumentation Laboratory CO · GFO · Mar 16, 2016 · Hematology

Device Facts

• Record ID: K160445
• Device Name: HemosIL Silica Clotting Time
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Mar 16, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

Device Story

HemosIL Silica Clotting Time is an in vitro diagnostic reagent used to detect Lupus Anticoagulants in human plasma; modification involves updating package insert labeling regarding heparin interference; replaces specific heparin reference levels with warning that heparin presence may cause falsely prolonged clotting times; intended for clinical laboratory use; fundamental scientific technology remains unchanged; no physical device modifications; no impact on safety or effectiveness.

Clinical Evidence

No clinical data; bench testing only; no verification or validation studies required due to nature of labeling-only modification.

Technological Characteristics

In vitro diagnostic reagent kit for coagulation testing. Uses phospholipid-sensitized reagents to detect Lupus Anticoagulants via intrinsic pathway activation. Compatible with ACL TOP, ACL Futura, ACL Advance, and ACL ELITE/ELITE PRO analyzer families. Standalone reagent system; no changes to formulation, materials, or hardware.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the determination of Silica Clotting Time (SCT) in human plasma to aid in the detection of Lupus Anticoagulants (LA).

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• HemosIL Silica Clotting Time (K050221)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2016

Instrumentation Laboratory Co. Ms. Heather L. Harvey Regulatory Affairs Specialist I 180 Hartwell Road Bedford, MA 01730

Re: K160445

Trade/Device Name: HemosIL Silica Clotting Time Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GFO Dated: February 16, 2016 Received: February 18, 2016

Dear Ms. Harvey:

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

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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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) K160445

Device Name HemosIL Silica Clotting Time

Indications for Use (Describe)

HemosiL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications"(March 20, 1998).

| Submitter's Information | Instrumentation Laboratory (IL) Co.<br>180 Hartwell Road<br>Bedford, MA 01730, USA | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact Person | Heather L Harvey, Regulatory Affairs Specialist I<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Preparation Date | March 8, 2016 | |
| Device Trade Name | HemosIL Silica Clotting Time | |
| Regulatory Information | Classification: | Class II |
| | Regulation No.: | 21 CFR 864.7925 |
| | Common Name: | Activated Partial Thromboplastin |
| | Panel: | Hematology (81) |
| | Product Code: | GFO |
| Predicate Device | HemosIL Silica Clotting Time<br>510(k) No.: K050221 | |
| Device Indications for Use /<br>Intended Use | HemosIL Silica Clotting Time is intended for the detection of Lupus<br>Anticoagulants in human citrated plasma on the IL Coagulation<br>Systems by the use of screening (SCT Screen) and confirmatory (SCT<br>Confirm) reagents sensitized to phospholipid dependent antibodies.<br>For <i>in vitro</i> diagnostic use. | |
| Device Description | The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is<br>intended to simplify and standardize the detection of Lupus<br>Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in<br>phospholipid making it sensitive to LA. The additional amount of<br>phospholipid in SCT Confirm neutralizes LA to give shorter clotting<br>times.<br>Silica Clotting Time in the presence of calcium, directly activates the<br>intrinsic pathway of coagulation. SCT Screen and SCT Confirm are<br>therefore unaffected by factor VII deficiencies or inhibitors. | |

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### Comparison to Predicate:

The HemosIL Silica Clotting Time insert sheet is being updated to remove the current Heparin interference references in the Summary and Principle section and the Limitations/ Interfering Substances section based on current guidance H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline (April 2014), with the associated references added to the Bibliography section. There is no change to the assay itself.

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 stability claims or to storage instructions
- 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 test parameters
- No change to calibration
- No change to quality controls

Following is a description of the similarities and differences between the currently marketed HemosIL Silica Clotting Time (K050221) and HemosIL Silica Clotting Time with the insert sheet modifications:

| Similarities | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Item | Predicate (K050221) | Modified Device |
| Indications for Use | HemosIL Silica Clotting Time is intended<br>for the detection of Lupus<br>Anticoagulants in human citrated<br>plasma on the IL Coagulation Systems by<br>the use of screening (SCT Screen) and<br>confirmatory (SCT Confirm) reagents<br>sensitized to phospholipid dependent<br>antibodies. | Same |
| Methodology | Clotting Time in the presence of reagents | Same |
| Analyzers | ACL TOP® Family<br>ACL Futura/ACL Advance<br>ACL ELITE®/ELITE PRO 8/9/10000 | Same |
| Sample Type | Citrated Plasma Samples | Same |

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### Comparison to Predicate (Cont.):

| Differences | | | | |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ltem | Predicate (K050221) | Modified Device | | |
| Insert Sheet<br>Summary and Principle<br>Section | Silica Clotting Time in the<br>presence of calcium, directly<br>activates the intrinsic pathway of<br>coagulation. SCT Screen and SCT<br>Confirm are therefore unaffected<br>by factor VII deficiencies or<br>inhibitors. Heparin interference<br>up to 0.4 U/mL is neutralized by<br>polybrene. Using a ratio of<br>screen and confirm allows the<br>SCT to be insensitive to warfarin<br>treated samples. | Silica Clotting Time in the presence<br>of calcium, directly activates the<br>intrinsic pathway of coagulation.<br>SCT Screen and SCT Confirm are<br>therefore unaffected by factor VII<br>deficiencies or inhibitors. Using a<br>ratio of screen and confirm allows<br>the SCT to be insensitive to<br>warfarin treated samples. Per CLSI<br>Guideline H-60, patient samples<br>containing heparin may exhibit<br>falsely prolonged clotting times<br>which could lead to incorrect<br>results. | | |
| Insert Sheet<br>Limitations/ Interfering<br>Substances Section | SCT Screen/SCT Confirm results<br>on the ACL Futura/ACL Advance<br>and ACL ELITE/ELITE PRO<br>8/9/10000 are not affected by<br>bilirubin up to 30 mg/dL,<br>triglycerides up to 500 mg/dL<br>and Heparin up to 0.4 U/mL. Do<br>not use hemolyzed samples.<br>SCT Screen/SCT Confirm results<br>on the ACL TOP Family are not<br>affected by bilirubin up to 30<br>mg/dL, triglycerides up to 850<br>mg/dL, UF Heparin up to 0.5<br>U/mL and LMW Heparin up to<br>1.0 U/mL. Do not use hemolyzed<br>samples.<br>LA assays based on different<br>properties appear to be more or<br>less sensitive to certain<br>subgroups of LAs. Therefore at<br>least two screening assays, based<br>on different properties, should<br>be performed before the<br>possibility of LA is excluded. | SCT Screen/SCT Confirm results on<br>the ACL Futura/ACL Advance and<br>ACL ELITE/ELITE PRO 8/9/10000 are<br>not affected by bilirubin up to 30<br>mg/dL, triglycerides up to 500<br>mg/dL. Do not use hemolyzed<br>samples.<br>SCT Screen/SCT Confirm results on<br>the ACL TOP Family are not<br>affected by bilirubin up to 30<br>mg/dL, and triglycerides up to 850<br>mg/dL. Do not use hemolyzed<br>samples.<br>Per CLSI Guideline H-60, patient<br>samples containing heparin may<br>exhibit falsely prolonged clotting<br>times which could lead to incorrect<br>results. LA assays based on<br>different properties appear to be<br>more or less sensitive to certain<br>subgroups of LAs. Therefore at<br>least two screening assays, based<br>on different properties, should be<br>performed before the possibility of<br>LA is excluded. | | |

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### Conclusion:

HemosIL Silica Clotting Time, with the modified Summary and Principle and Limitations/ Interfering Substances insert sections, is substantially equivalent to the legally marketed predicate device FDA cleared under K050221.