HemosIL High Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA™ Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.

Values for all analytes are in the high abnormal range.

Device Description

Available as an assayed high abnormal control (HemosIL High Abnormal Control) or unassayed high abnormal control (HemosIL High Abnormal Control 3), the product is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRATM Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to simulate an abnormal coagulation sample.

AI/ML Overview

Here's an analysis of the provided text regarding the HemosIL High Abnormal Control, focusing on acceptance criteria and the supporting study:

The provided document describes a quality control device (HemosIL High Abnormal Control) for coagulation assays. As such, the "acceptance criteria" and "device performance" are focused on the device's precision in measuring known analytes, rather than diagnostic accuracy against a ground truth for individual patient samples.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for the precision study results. Instead, it presents the results of a precision study. For a quality control device, the reported "Within-Run %CV" values inherently represent the device's performance against an implicit expectation of low variability for accurate quality control. I will present the reported performance as the observed precision.

Analyte	Reported Within-Run %CV	(Implicit Acceptance: Low CV for Quality Control)
Activated Partial Thromboplastin (APTT)	2.62%	Lower CV indicates better precision
Antithrombin	9.90%	Lower CV indicates better precision
Protein C	6.11%	Lower CV indicates better precision
Protein S	2.75%	Lower CV indicates better precision
Prothrombin Time (PT)	1.61%	Lower CV indicates better precision

Note: The document only provides within-run CVs. A full precision study typically includes total CV (inter-run, inter-day, inter-lot, etc.). However, only "Within-Run %CV" is reported here.

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

Test Set Sample Size (n):
- Activated Partial Thromboplastin (APTT): N = 80
- Antithrombin: N = 80
- Protein C: N = 80
- Protein S: N = 40
- Prothrombin Time (PT): N = 80
Data Provenance: The document states the study was performed "over multiple days with multiple runs using specific lots of reagents and control." The device itself is "prepared using human citrated plasma from healthy donors." The study details do not specify the country of origin. The study is prospective in nature, as it describes a controlled experiment to evaluate the device's performance.

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

This question is not applicable to this device and study. The HemosIL High Abnormal Control is a quality control material, not a diagnostic device that interprets patient samples or images. Its "ground truth" is its own formulated "target values" for the analytes it controls. The study evaluates the precision of the device in consistently measuring these internal known values, not its accuracy against an external "ground truth" established by experts.

4. Adjudication Method for the Test Set

This question is not applicable as there is no expert interpretation or diagnostic decision being made that would require adjudication. The study is a quantitative measurement of precision.

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

This question is not applicable. This is not an AI/imaging device, nor is it a device that involves human readers or interpretation of cases. It is a laboratory quality control material.

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

This question is not applicable. This is not an algorithm-based device. It's a laboratory reagent. The performance reported (precision) is inherent to the control material and the analytical system it's used with, which can be seen as "standalone" in the sense that the results are quantitative measures from the system.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is its intended (manufactured) analyte concentration/activity values. The HemosIL High Abnormal Control is designed to simulate an abnormal coagulation sample with specific, known levels of APTT, Antithrombin, Protein C, Protein S, and PT. The study's "Mean" values (e.g., 64.4 seconds for APTT) represent the experimentally determined average for those manufactured values, and the "Within-Run %CV" indicates how consistently the device and system measure these known values.

8. The Sample Size for the Training Set

This question is not applicable. This device is a quality control material, not an AI or machine learning model that requires a "training set."

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

This question is not applicable for the same reason as #8. No training set is involved.

Summary

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K021024

Section 3

HemosIL High Abnormal Control - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

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

Contact Person:

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

Summary Prepared:

March 28, 2002

Name of the Device(s):

HemosIL High Abnormal Control ASSAYED HemosIL High Abnormal Control 3 UNASSAYED

Classification Name(s):

Common Name:	Plasma Coagulation Control
Product Code:	81GGN
Regulation Number:	21 CFR 864.5425
Classification:	Class II

Identification of Predicate Device(s):

510(k) No.	Predicate Device(s)	Analytes
K931118	Assess™ High Abnormal Control	Prothrombin Time (PT)Activated PartialThromboplastin (APTT)
K864271	IL Test™ Abnormal Chromogenic Control PlasmaLevel 2	Antithrombin
K912711	IL Test™ Protein C Control Plasma(component of IL Test™ ProClot kit)	Protein C
K930327	IL Test™ Protein S Control Plasma(component of IL Test™ Protein S kit)	Protein S

Description of the Device/Intended Use(s):

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

HemosIL High Abnormal Control is substantially equivalent to the predicate devices in performance, intended use and safety and effectiveness for the specific claimed analyte.

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Section 3 (Cont.) HemosIL High Abnormal Control - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

A precision study was performed with HemosIL High Abnormal Control over multiple days with multiple runs using specific lots of reagents and control:

Analyte	n=	Mean	Within-Run%CV
Activated Partial Thromboplastin (APTT)(Seconds)	80	64.4	2.62
Antithrombin(% Activity)	80	22.8	9.90
Protein C(% Activity)	80	14.4	6.11
Protein S(% Activity)	40	29.5	2.75
Prothrombin Time (PT)(Seconds)	80	43.6	1.61

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 6 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: K021024

Trade/Device Name: HemosIL High Abnormal Control ASSAYED HemosIL High Abnormal Control 3 UNASSAYED Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 28, 2002 Received: March 29, 2002

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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

8021024 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Names: HemosIL High Abnormal Control ASSAYED

Indications for Use:

Values for all analytes are in the high abnormal range.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K021024

Prescription Use(Per 21 CFR 801.019)	OR	Over-The-Counter Use
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HemosIL High Abnormal Control 510(k)

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.