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 Description

The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times. Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors.

AI/ML Overview

This document is not structured as a typical study report, but rather as a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification is made to a legally marketed device, and the modification does not affect the device's indications for use or its fundamental scientific technology. In this case, the modification is to the device's labeling (specifically, clarifying heparin interference information) based on updated guidance (CLSI Guideline H60-A).

Therefore, the primary "study" proving the device meets acceptance criteria in this context is the demonstration that the changes are only to the labeling and do not impact the assay's performance compared to the predicate device. This type of submission relies heavily on the predicate's prior clearance and the assertion that the core device technology and performance remain unchanged.

Given this, I will describe the "acceptance criteria" and "device performance" in terms of substantiating that the change in labeling does not alter the device's substantial equivalence to its predicate.

Here's the breakdown of information, addressing your points where applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Special 510(k) regarding labeling change)	Reported Device Performance (as stated in the 510(k) summary)
No change in indications for use or intended use: The modified device must serve the same clinical purpose as the predicate.	"No change in indications for use or intended use." The Indications for Use for both predicate and modified device are: "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."
No change in operating principle: The core scientific methodology by which the device functions must remain the same.	"No change in operating principle." The methodology is described as "Clotting Time in the presence of reagents" for both.
No change to stability claims or to storage instructions: The shelf life and handling requirements for the reagents must be unaltered.	"No change to stability claims or to storage instructions."
No change to reagent preparation: The procedure for preparing the HemosIL SCT reagents (SCT Screen and SCT Confirm) must be the same.	"No change to reagent preparation."
No change to specimen collection and preparation: The requirements for patient sample collection and handling must be unchanged.	"No change to specimen collection and preparation."
No change to formulation or materials: The chemical composition and components of the reagents must be identical.	"No change to formulation or materials." The device description for both predicate and modified remains: "The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times."
No change to data reduction software: Any software used to process or interpret the results from the device must be the same.	"No change to data reduction software."
No change to test parameters: The settings or conditions under which the test is performed must be identical.	"No change to test parameters."
No change to calibration: The calibration procedure and standards must remain the same.	"No change to calibration."
No change to quality controls: The quality control materials and procedures must be unchanged.	"No change to quality controls."
Demonstration that the only changes are to the insert sheet for clarity regarding heparin interference, based on current guidance (CLSI Guideline H60-A), and that these changes do not alter the analytical or clinical performance of the device.	The submission explicitly states the changes are 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." The core assertion is: "There is no change to the assay itself."

2. Sample size used for the test set and the data provenance
The document describes a Special 510(k) submission. This type of submission is based on the premise that there are no actual changes to the device's performance, but rather to its labeling or minor design aspects.
Therefore, no new "test set" data from patient samples is typically required or provided for a Special 510(k) for a labeling change. The claim of substantial equivalence rests on the device being unchanged and performing as cleared under its predicate (K050221). The "study" here is the comparison demonstrating no change to the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No new clinical or analytical performance study requiring a ground truth determination from experts on a new test set was conducted for this Special 510(k) submission. The changes are to informational labeling based on a published guideline (CLSI H60-A).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new test set requiring expert adjudication was utilized for this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in vitro diagnostic (IVD) reagent for a laboratory test (detection of Lupus Anticoagulants), not an imaging device or an AI-powered diagnostic system designed for human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an IVD reagent, not an algorithm. Its performance is measured directly by clinical laboratory methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable to this Special 510(k) based on a labeling change. The original predicate device (K050221) would have established its performance against appropriate reference methods or clinical outcomes during its initial clearance process. For this submission, the "ground truth" is that the device itself has not changed and therefore its previously established performance holds. The update to the labeling regarding heparin interference aligns with an industry-accepted guideline (CLSI Guideline H60-A).

8. The sample size for the training set
Not applicable. No training set was used for this Special 510(k) submission.

9. How the ground truth for the training set was established
Not applicable. No training set was used for this Special 510(k) submission.

In summary of the "study":

The "study" in this Special 510(k) is a comparison study that demonstrates the "modified device" is identical in all functional aspects to the "predicate device," with the only changes being to the instructional labeling regarding heparin interference. The acceptance criterion is that no functional or performance changes were introduced, and therefore the device remains substantially equivalent to the previously cleared predicate (K050221). The proof is in the documentation confirming no changes to formulation, operating principle, indications for use, stability, specimen requirements, software, or test parameters.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.180 Hartwell RoadBedford, MA 01730, USA
Contact Person	Heather L Harvey, Regulatory Affairs Specialist IPhone: 781-861-4549Fax: 781-861-4207Email: hharvey@ilww.com
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 Time510(k) No.: K050221
Device Indications for Use /Intended Use	HemosIL Silica Clotting Time is intended for the detection of LupusAnticoagulants in human citrated plasma on the IL CoagulationSystems by the use of screening (SCT Screen) and confirmatory (SCTConfirm) reagents sensitized to phospholipid dependent antibodies.For in vitro diagnostic use.
Device Description	The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, isintended to simplify and standardize the detection of LupusAnticoagulants (LA) in clinical evaluations. SCT Screen is poor inphospholipid making it sensitive to LA. The additional amount ofphospholipid in SCT Confirm neutralizes LA to give shorter clottingtimes.Silica Clotting Time in the presence of calcium, directly activates theintrinsic pathway of coagulation. SCT Screen and SCT Confirm aretherefore 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 intendedfor the detection of LupusAnticoagulants in human citratedplasma on the IL Coagulation Systems bythe use of screening (SCT Screen) andconfirmatory (SCT Confirm) reagentssensitized to phospholipid dependentantibodies.	Same
Methodology	Clotting Time in the presence of reagents	Same
Analyzers	ACL TOP® FamilyACL Futura/ACL AdvanceACL 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 SheetSummary and PrincipleSection	Silica Clotting Time in thepresence of calcium, directlyactivates the intrinsic pathway ofcoagulation. SCT Screen and SCTConfirm are therefore unaffectedby factor VII deficiencies orinhibitors. Heparin interferenceup to 0.4 U/mL is neutralized bypolybrene. Using a ratio ofscreen and confirm allows theSCT to be insensitive to warfarintreated samples.	Silica Clotting Time in the presenceof calcium, directly activates theintrinsic pathway of coagulation.SCT Screen and SCT Confirm aretherefore unaffected by factor VIIdeficiencies or inhibitors. Using aratio of screen and confirm allowsthe SCT to be insensitive towarfarin treated samples. Per CLSIGuideline H-60, patient samplescontaining heparin may exhibitfalsely prolonged clotting timeswhich could lead to incorrectresults.
Insert SheetLimitations/ InterferingSubstances Section	SCT Screen/SCT Confirm resultson the ACL Futura/ACL Advanceand ACL ELITE/ELITE PRO8/9/10000 are not affected bybilirubin up to 30 mg/dL,triglycerides up to 500 mg/dLand Heparin up to 0.4 U/mL. Donot use hemolyzed samples.SCT Screen/SCT Confirm resultson the ACL TOP Family are notaffected by bilirubin up to 30mg/dL, triglycerides up to 850mg/dL, UF Heparin up to 0.5U/mL and LMW Heparin up to1.0 U/mL. Do not use hemolyzedsamples.LA assays based on differentproperties appear to be more orless sensitive to certainsubgroups of LAs. Therefore atleast two screening assays, basedon different properties, shouldbe performed before thepossibility of LA is excluded.	SCT Screen/SCT Confirm results onthe ACL Futura/ACL Advance andACL ELITE/ELITE PRO 8/9/10000 arenot affected by bilirubin up to 30mg/dL, triglycerides up to 500mg/dL. Do not use hemolyzedsamples.SCT Screen/SCT Confirm results onthe ACL TOP Family are notaffected by bilirubin up to 30mg/dL, and triglycerides up to 850mg/dL. Do not use hemolyzedsamples.Per CLSI Guideline H-60, patientsamples containing heparin mayexhibit falsely prolonged clottingtimes which could lead to incorrectresults. LA assays based ondifferent properties appear to bemore or less sensitive to certainsubgroups of LAs. Therefore atleast two screening assays, basedon different properties, should beperformed before the possibility ofLA 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.

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
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.(b)
Classification. Class II (performance standards).