HemosIL ProClot is an automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems. Protein C deficiency is associated with recurrent venous thrombosis and pulmonary embolism, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

Device Description

The ProClot kit is a functional clotting Protein C test, based on the prolongation of an APTT assay in presence of activated Protein C. The use of the APTT test to measure the anticoagulant effect of activated protein C is due to its sensitivity to FV and FVIII levels. Activated Protein C in plasma samples is generated by Protac , a rapid in vitro Protein C activator derived from the venom of the copperhead snake Agkistrodom contortrix contortrix.

AI/ML Overview

The provided text describes a Special 510(k) submission for the HemosIL ProClot device, focusing on a modification to its product insert regarding expected values. This submission is for a regulatory change, not a new device or a clinical performance study to establish new acceptance criteria.

Therefore, the information required to populate the fields regarding acceptance criteria and a study proving the device meets them is not available in the provided document. The submission is a request to modify the labeling based on published literature and reinforce the need for laboratories to establish their own normal ranges, rather than presenting original study data for performance validation against acceptance criteria.

However, I can extract information relevant to the device's regulatory context and the proposed change:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or new reported device performance data are provided in this document. The submission is about a labeling change, not a performance validation study.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No test set data is presented as part of this submission. The change is based on existing knowledge and literature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done or described in this submission. The document focuses on regulatory approval for a labeling change, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a functional clotting assay kit, not an algorithm.

7. Type of Ground Truth Used:

Literature-based. The information about expected values, including the normal range of 70-140% and low levels in neonates, is directly referenced from a published pathology and laboratory medicine journal article:
- Kottke-Marchant K, Comp P. Laboratory Issues in Diagnosing Abnormalities of Protein C, Thrombomodulin, and Endothelial Cell Protein C Receptor, Arch Pathol Lab med 2002; 126:1337-1348.
- The "ground truth" for the modified expected values section is therefore based on established medical literature.

8. Sample Size for the Training Set:

Not applicable. No training set for an algorithm or new device performance data is described. The device is a chemical reagent kit.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary of the Document's Purpose:

The document concerns a Special 510(k) submission for the HemosIL ProClot device. The core reason for this submission is to modify the "Expected Values" section of the product insert. This modification involves:

Referencing a normal range (70-140%) from published literature.
Reinforcing the critical need for each individual laboratory to establish its own normal (reference) range due to the inherent variability in results.

The submission states that the device with the modified insert is not materially different from the previously FDA-cleared device (K912711 HemosIL ProClot). Therefore, no new performance studies (like those requiring acceptance criteria, test sets, or ground truth establishment) are presented or required for this type of regulatory submission. The FDA's letter (K070635) confirms substantial equivalence to the predicate device based on the proposed labeling change.

Summary

{0}------------------------------------------------

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207

Summary Prepared:

March 22, 2007

Name of the Device:

HemosIL ProClot

Regulatory Information:

864.7290	Factor Deficiency Test	Class II
81GGP	Test, Qualitative and Quantitative Factor Deficient

Identification of Predicate Device(s):

K912711 HemosIL ProClot

Device Intended Use:

HemosIL ProClot is an automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems.

Device Description:

Reason for Submission:

The Expected Values section of the HemosIL ProClot insert is being modified to reference a normal range from published literature, reinforcing the need for each laboratory to establish its own normal [reference] range due to the many variables which may affect results.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL ProClot with the modified Expected Values section in the product insert is not materially different from the FDA cleared device.

Summary of Expected Values Section to the Modified Product Insert:

Protein C activity levels in healthy individuals are approximately in the range of 70 - 140%. Protein C levels are low in neonates and increase to adult levels during adolescence.*

Due to many variables which may affect results, each laboratory should establish its own normal range.

- Kottke-Marchant K, Comp P. Laboratory Issues in Diagnosing Abnormalities of Protein C, Thrombomodulin, and Endothelial Cell Protein C Receptor, Arch Pathol Lab med 2002; 126:1337-1348.
  Special 510(k): HemosIL ProClot

K070635

MAR 2 9 2007

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INSTRUMENTATION LABORATORY CO. 113 Hartwell Ave. Lexington, MA 02421 Attn: Carol Marble

MAR 2 9 2007

Re: K070635

Trade/Device Name: HemosIL ProClot Regulation Number: 21 CFR 864.7290 Regulation Name: Test, Qualitative and Quantitative Factor Deficiency Regulatory Class: Class II Product Code: GGP Dated: March 06, 2007 Received: March 07, 2007

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{2}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert L. Becker f

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): _ H O 70635

Device Name: HemosIL ProClot

Indications for Use:

Hemos L ProClot is an automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems. Protein C deficiency is associated with recurrent venous thrombosis and pulmonary embolism, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070635

Special 510(k): HemosIL ProClot

Regulation Number and Section

§ 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).