HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems. For in vitro diagnostic use.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the HemosIL PT-Fibrinogen HS PLUS device, broken down by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Assay	System	Acceptance Criteria (Range - units)	Reported Device Performance (Range - units)
PT	ACL Futura/ACL Advance	Not explicitly stated as "acceptance criteria," but implied as the target normal range update for the device.	11.1 - 14.5 (seconds)
Fibrinogen	ACL Futura/ACL Advance	Not explicitly stated as "acceptance criteria," but implied as the target normal range update for the device.	262 - 433 (mg/dL)

Note: The document presents the "new expected values data" as the outcome of the study, rather than pre-defined acceptance criteria. The purpose of this submission was to update these expected values based on new data, implying that the study's success was determined by the derivation of these new ranges.

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

Test Set Sample Size: 119
Data Provenance: Not explicitly stated within the document for country of origin. The study was conducted to establish "new normal range study," implying it was a prospective study to determine reference ranges from a healthy population.

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

This document does not describe the use of "experts" for establishing ground truth in the context of interpreting the results. The "ground truth" here is the measured PT and Fibrinogen values from the healthy individuals in the normal range study. The device itself performs the measurement.

4. Adjudication Method for the Test Set

Not applicable. The study is establishing reference ranges for a quantitative diagnostic test, not interpreting complex medical images or information requiring adjudication.

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

No. This document describes a normal range study for a quantitative diagnostic assay, not a comparative effectiveness study involving human readers.

6. Standalone Performance Study

Yes, in a sense. The data presented are from the device (HemosIL PT-Fibrinogen HS PLUS on ACL Futura/ACL Advance systems) measuring PT and Fibrinogen in human plasma. This is a standalone performance of the algorithm/reagent system as it's designed to operate for in vitro diagnostic use. The study focuses on the values obtained by the device itself.

7. Type of Ground Truth Used

The "ground truth" in this context is the measured Prothrombin Time and Fibrinogen values obtained from a population of apparently healthy individuals. It's essentially the observed data from the device itself when run on a specific population to define normal ranges.

8. Sample Size for the Training Set

Not mentioned. This document describes a study to establish reference ranges for the device, not a machine learning model that would require a separate training set. The normal range study sample of 119 individuals could be considered the "data" from which the expected values were derived.

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

Not applicable for a typical machine learning "training set" as described in the prompt. For the normal range study, the "ground truth" (the observed PT and Fibrinogen values) was established by running the HemosIL PT-Fibrinogen HS PLUS on the ACL Futura/ACL Advance systems with human citrated plasma from the 119 individuals in the study. The definition of a "normal" range is statistical, based on the distribution of these measured values within that population.

Summary

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K060931

Section 3 HemosIL PT-Fibrinogen HS PLUS 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

MAY 2 2005

Contact Person:

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

Summary Prepared:

April 4, 2006

Name of the Device:

HemosIL PT-Fibrinogen HS PLUS

Regulatory Information:

864.7750	Prothrombin Time Test	Class II
81GJS	Test, Time, Prothrombin
864.7340	Fibrinogen Determination System	Class II
81GIS	Test, Fibrinogen

Identification of Predicate Device(s):

K933252 HemosIL PT-Fibrinogen HS PLUS

Device Description:

Reason for Submission:

The expected value ranges for PT and Fibrinogen on the ACL Futura/ACL Advance provided in the product insert for HemosIL PT-Fibrinogen HS PLUS are being updated based on data from a new normal range study.

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

The performance of HemosIL PT-Fibrinogen HS PLUS with the new expected value ranges for the ACL Futura and ACL Advance is not materially different from the FDA cleared device.

Summary of New Expected Values Data:

Assay	System	N	Range (units)
PT	ACL Futura/ACL Advance	119	11.1 - 14.5 (seconds)
Fibrinogen	ACL Futura/ACL Advance	119	262 - 433 (mg/dL)

These results were obtained using a specific lot of reagent. Due to the many variables which may affect clotting times, each laboratory should establish its own reference range.

Section 3	Special 510(k): HemosIL PT-Fibrinogen HS PLUS	Page 1 of 1
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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 stylized eagle with three tail feathers. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director MAY Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

2 3005

Re: K060931

Trade/Device Name: HemosIL PT-Fibrinogen HS PLUS Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin time test Regulatory Class: II Product Code: GJS, GIS Dated: April 4, 2006 Received: April 5, 2006

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K060931

Device Name: HemosIL PT-Fibrinogen HS PLUS

Indications for Use:

For in vitro diagnostic use.

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 Step-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Section 2

Special 510(k): HemosIL PT-Fibrinogen HS PLUS

Page 1 of 1

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).