HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

Device Description

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X in the patient plasma, interpolated from a calibration curve.

AI/ML Overview

Acceptance Criteria and Study for HemosIL Factor X Deficient Plasma

This document describes the acceptance criteria and the study that demonstrates the HemosIL Factor X Deficient Plasma device meets these criteria, as derived from the provided 510(k) summary (K031122).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance metrics presented for substantial equivalence to predicate devices. These criteria are based on method comparison (slope and correlation coefficient) and precision (within-run and between-run coefficient of variation).

Metric / Test Type	Predicate Device 1 (Hemoliance Factor X Deficient Plasma on ELECTRA)	Predicate Device 2 (IL Test Factor X Deficient Plasma on ACL Family)	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (HemosIL Factor X Deficient Plasma)
Method Comparison				vs. Predicate Hemoliance Factor X Deficient Plasma on ELECTRA:ELECTRA 1600C (n=63): Slope = 0.9461, r = 0.9948vs. Predicate IL Test Factor X Deficient Plasma on ACL Family:ACL 3000 (n=62): Slope = 1.0328, r = 0.9849ACL Futura (n=62): Slope = 1.0680, r = 0.9840
Slope	A slope close to 1.0 (indicating proportional agreement)	A slope close to 1.0 (indicating proportional agreement)	Demonstrated to be close to 1.0 across different systems and predicates (e.g., 0.9461 to 1.0680).
Correlation Coefficient (r)	A high correlation coefficient (typically ≥ 0.975 as a common standard for method comparison in IVDs)	A high correlation coefficient (typically ≥ 0.975)	Demonstrated to be high across different systems and predicates (e.g., 0.9840 to 0.9948).
Within Run Precision	(Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs)	(Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs)	CV% for Normal Control: Low (e.g., < 5%)CV% for Low Abnormal Control: Low (e.g., < 7%)	ACL 300: Normal Control: 3.5%Low Abnormal Control: 4.1%ACL 6000: Normal Control: 3.3%Low Abnormal Control: 3.0%ACL 9000: Normal Control: 1.4%Low Abnormal Control: 1.9%ACL Futura: Normal Control: 4.2%Low Abnormal Control: 5.0%ELECTRA 1400C: Normal Control: 0.9%Low Abnormal Control: 1.7%
Between Run Precision	(Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs)	(Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs)	CV% for Normal Control: Low (e.g., < 7%)CV% for Low Abnormal Control: Low (e.g., < 10%)	ACL 300: Normal Control: 4.6%Low Abnormal Control: 6.0%ACL 6000: Normal Control: 4.3%Low Abnormal Control: 4.8%ACL 9000: Normal Control: 2.1%Low Abnormal Control: 4.4%ACL Futura: Normal Control: 4.5%Low Abnormal Control: 6.1%ELECTRA 1400C: Normal Control: 2.9%Low Abnormal Control: 2.4%

Note: The acceptance criteria for the predicate devices are not explicitly stated in this summary. However, for a 510(k) submission, the new device is typically considered to meet acceptance criteria if its performance is "substantially equivalent" to that of the predicate device. This usually implies that the reported performance metrics for the new device fall within acceptable ranges relative to the predicate, often demonstrated by meeting similar or better statistical measures (slopes close to 1, high correlation coefficients, and low coefficients of variation).

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

Sample Sizes:
- Method Comparison (vs. Hemoliance Factor X Deficient Plasma on ELECTRA): n = 63 citrated plasma samples (normal and abnormal)
- Method Comparison (vs. IL Test Factor X Deficient Plasma on ACL Family): n = 62 citrated plasma samples (normal and abnormal) for both ACL 3000 and ACL Futura.
- Precision Studies: n = 80 measurements (over multiple runs) for each control level (Normal Control and Low Abnormal Control) on each instrument (ACL 300, ACL 6000, ACL 9000, ACL Futura, ELECTRA 1400C).
Data Provenance: The studies were conducted as "field site studies." The country of origin of the data is not specified, but given the applicant's location (Lexington, MA, USA), it is likely to be primarily U.S. data. The data is retrospective in the sense that existing plasma samples were used, or it could be prospective if samples were collected for the purpose of the study. The summary does not specify this detail.

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

This information is not applicable and not provided in the given 510(k) summary. For in vitro diagnostic devices like HemosIL Factor X Deficient Plasma, "ground truth" is typically established by the reference method or comparative method (the predicate device) itself, or by accepted laboratory standards/controls, rather than expert consensus on diagnostic images or clinical outcomes. The performance is assessed by comparing the device's quantitative output to known values (controls) or to the results from the predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image reading, where multiple experts interpret data independently and then resolve discrepancies. For a quantitative diagnostic like Factor X activity, the measurement itself is the primary output, and discrepancies would typically be handled by re-testing or applying established quality control rules, not expert adjudication in the same sense.

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

This information is not applicable and not provided. MRMC studies are relevant for devices where human readers interpret data, often with or without AI assistance, and the impact of the AI on reader performance is evaluated. The HemosIL Factor X Deficient Plasma is a laboratory reagent used in an automated system, not a device that involves human reader interpretation in the context of an MRMC study.

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

The studies presented are effectively standalone performance studies for the device. The "algorithm" here is the chemical reaction and measurement process of the HemosIL Factor X Deficient Plasma test on the specified automated coagulation analyzers (IL Coagulation and ELECTRA Systems). The performance data (method comparison, precision) reflects the device's analytical performance independent of human interpretive input in the diagnostic process.

7. Type of Ground Truth Used

The "ground truth" for the test set was established through:

Comparative Analysis with Predicate Devices: For the method comparison studies, the results obtained using the HemosIL Factor X Deficient Plasma were compared against the results obtained using the legally marketed predicate devices (Hemoliance Factor X Deficient Plasma and IL Test Factor X Deficient Plasma). The predicate devices' results served as the reference or comparative "ground truth."
Control Materials: For the precision studies, Normal Control and Low Abnormal Control materials with known or expected Factor X activity levels were used. These control materials serve as an established reference for evaluating the accuracy and reproducibility of the device.

8. Sample Size for the Training Set

This information is not applicable and not provided in the given 510(k) summary. This device is a diagnostic reagent, not a machine learning or AI-based system that requires a "training set" in the typical sense of algorithm development. Its performance is based on chemical and electrochemical principles.

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

This information is not applicable and not provided as there is no "training set" for this type of device.

Summary

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K031122

Section 3 HemosIL Factor X Deficient Plasma - 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:

April 7, 2003

Name of the Device:

HemosIL Factor X Deficient Plasma

Classification Name(s):

864.7290	Factor Deficiency Tests	Class II
81GJT	Plasma, Coagulation Factor Deficient

Identification of Predicate Device(s):

K893523	Hemoliance Factor X Deficient Plasma on ELECTRA Series Analyzers
K002400	IL Test Factor X Deficient Plasma* on ACL Family of Analyzers
*NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems, mostrecently the ACL Advance.

Description of the Device/Intended use(s):

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

HemosIL Factor X Deficient Plasma is substantially equivalent to Hemoliance Factor X Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor X Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.

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Section 3 HemosIL Factor X Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In field site studies evaluating citrated plasma samples (normal and abnormal), the slopes and correlation coefficients (r) for HemosIL Factor X Deficient Plasma versus the predicate devices are shown below:

HemosIL Factor X Deficient Plasma vs. Predicate Hemoliance Factor X Deficient Plasma on ELECTRA

IL System	n	Slope	r	PT Reagent Used
ELECTRA 1600C	63	0.9461	0.9948	RecombiPlasTin (K012768)

HemosIL Factor X Deficient Plasma vs. Predicate IL Test Factor X Deficient Plasma on ACL Family

IL System	an and the first of the first of the first of the first of the first of the first of the first of the first for the first of the first for the first for the first for the fir	Slope		PT Reagent Used
ACL 3000	62	1.0328	0.9849	PT-Fibrinogen Recombinant (K981479)
ACL Futura	62	1.0680	0.9840	PT-Fibrinogen Recombinant (K981479)

Within Run Precision

Within run and total precision assessed over multiple runs (n=80) using two levels of control gave the following results:

Instrument	Control	Mean% Factor X	Within RunCV%	Between RunCV%
ACL 300	Normal Control	113.2	3.5	4.6
	Low Abnormal Control	38.9	4.1	6.0
ACL 6000	Normal Control	114.0	3.3	4.3
	Low Abnormal Control	29.9	3.0	4.8
ACL 9000	Normal Control	117.7	1.4	2.1
	Low Abnormal Control	27.1	1.9	4.4
ACL Futura	Normal Control	96.3	4.2	4.5
	Low Abnormal Control	38.9	5.0	6.1
ELECTRA1400C	Normal Control	96.6	0.9	2.9
	Low Abnormal Control	27.5	1.7	2.4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 9 2003

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

K031122 Trade/Device Name: HemosIL Factor X Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: April 7, 2003 Received: April 8, 2003

Dear Ms. Marble:

Re:

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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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL Factor X Deficient Plasma

Indications for Use:

(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	K 031122
510(k) Number

Prescription Use
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Over-The-Counter Use
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HemosIL Factor X Deficient Plasma 510(k)

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).