HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.

This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.

Device Description

The reconstituted and onboard stability claims for HemosIL ProS on the ACL Futura (K951891) and ACL Advance (K002400) are being revised as a precautionary measure based on indications from internal QC release data on multiple product lots.

AI/ML Overview

Here's an analysis of the provided text regarding the HemosIL ProS device, focusing on the requested information for acceptance criteria and the supporting study:

Disclaimer: The provided document is a 510(k) summary for a modification to a previously cleared device. It primarily focuses on changes to stability claims. Therefore, the depth of information on all requested points might be limited compared to an initial 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Onboard Stability Claim (ACL Futura/Advance)	Revised to 1 hour (from previous, unspecified claim)
Reconstituted 2-8°C Stability Claim (ACL Futura/Advance)	Revised to 12 hours (from previous, unspecified claim)
Other Performance Parameters (e.g., accuracy, precision, linearity)	"All other performance testing was within specification and is consistent with the currently labeled claims in the product insert for HemosIL ProS." (Specific criteria and performance values not detailed in this summary.)

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

Sample Size: Not explicitly stated for the stability testing. The summary refers to "internal QC release data on multiple product lots."
Data Provenance: "Internal QC release data," implying it's from the manufacturer (Instrumentation Laboratory Company) and likely refers to testing conducted in their facilities. The country of origin is implicitly the US (Lexington, MA).
Retrospective/Prospective: Not specified, but generally, QC release data would be a form of prospective testing during manufacturing. The "additional stability testing" for the revised claims would also be prospective.

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

Not Applicable. This document pertains to an in-vitro diagnostic (IVD) assay for measuring Protein S. The "ground truth" for such assays typically relies on established analytical methods and reference materials, not expert interpretation of images or patient data. The "ground truth" for stability would be the actual measured stability performance over time.

4. Adjudication Method for the Test Set:

Not Applicable. As mentioned above, this is an IVD assay, not a diagnostic imaging or clinical interpretation device that would require adjudication of expert opinions. The assessment of stability would be based on predefined analytical specifications and statistical analysis of quantitative measurements.

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 a standalone in-vitro diagnostic assay and does not involve human "readers" in the context of interpreting results in combination with AI. It measures a specific biochemical marker.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, effectively. The HemosIL ProS is a standalone in-vitro diagnostic assay. Its performance is evaluated intrinsically through laboratory testing (e.g., stability, accuracy, precision) without human interpretation in the loop of the primary measurement. The "algorithm" here refers to the chemical reactions and optical detection methods of the assay itself, rather than a separate AI algorithm processing data.

7. The Type of Ground Truth Used:

For the core functionality of the device (quantitative determination of free Protein S), the ground truth would be established through a combination of:
- Reference materials/calibrators: Samples with known concentrations of Protein S.
- Reference methods: Established, often more laborious, analytical methods for Protein S measurement.
- Clinical correlation: (Though not extensively detailed in this summary, an initial 510(k) for such a device would likely correlate results with patient diagnostic status, potentially against a "gold standard" clinical diagnosis or another validated Protein S assay.)
For the stability claims (the focus of this K053499 submission), the ground truth is the actual measured concentration of Protein S in control samples over time, compared to initial measurements, to determine if the device's accuracy remains within acceptable limits.

8. The Sample Size for the Training Set:

Not Applicable/Not Provided. This is not an AI/machine learning device that typically has "training sets." The "training" for such an assay involves method development and optimization, which utilizes various reagent lots and samples, but not in the sense of a dedicated training set for an algorithm. The stability testing itself relies on a number of control samples and product lots (as mentioned, "multiple product lots").

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

Not Applicable/Not Provided. As it's not an AI/ML device with a training set in the conventional sense, this question does not apply. The "ground truth" in the context of stability testing is the direct analytical measurement against a specified initial value or an established range.

Summary

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

K053499

JAN 1 3 2006 Section 3

HemosIL ProS 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

December 15, 2005

Name of the Device:

HemosIL ProS

Classification Name:

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

Identification of Predicate Device(s):

K011424 HemosIL ProS

Description of the Modified Device:

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

The performance of HemosIL ProS with modified stability claims for the ACL Futura and ACL Advance is not materially different from the FDA cleared device.

Summary of Performance Data:

Based on additional stability testing on the ACL Futura/ACL Advance, we are revising the onboard claim to 1 hour and the reconstituted 2-8℃ claim to 12 hours to ensure the optimal integrity of the product in the field.

All other performance testing was within specification and is consistent with the currently labeled claims in the product insert for HemosIL ProS.

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

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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JAN 1 3 2006

Re: K053499

Trade/Device Name: HemosIL ProS Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency test Regulatory Class: II Product Code: GGP Dated: December 15, 2005 Received: December 20, 2005

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.

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

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,

lobetz Beckerh

Robert L. Becker, Jr., MD, PAD 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): K053499

Device Name: HemosIL ProS

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)

Division/Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

K053499

Special 510(k): HemosIL ProS

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).