HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems. 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 VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor VII Deficient Plasma device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence rather than meeting explicit acceptance criteria in the traditional sense of pre-defined thresholds. The performance is compared directly to predicate devices.

Performance Metric	Acceptance Criteria (Implicit - Substantial Equivalence to Predicate)	Reported Device Performance	Comments
Method Comparison
Slope (vs. Hemoliance on ELECTRA E1400C)	Close to 1.0 (indicating good agreement)	0.9683	This value is very close to 1.0, suggesting strong agreement with the predicate on the ELECTRA system.
Correlation (r) (vs. Hemoliance on ELECTRA E1400C)	Close to 1.0 (indicating strong linear correlation)	0.9967	This high correlation coefficient (r) indicates a very strong linear relationship between the new device and the predicate.
Slope (vs. IL Test on ACL 300)	Close to 1.0	1.0045	Excellent agreement.
Correlation (r) (vs. IL Test on ACL 300)	Close to 1.0	0.9994	Very strong correlation.
Slope (vs. IL Test on ACL 6000)	Close to 1.0	0.9646	Strong agreement.
Correlation (r) (vs. IL Test on ACL 6000)	Close to 1.0	0.9989	Very strong correlation.
Slope (vs. IL Test on ACL 9000)	Close to 1.0	0.9778	Strong agreement.
Correlation (r) (vs. IL Test on ACL 9000)	Close to 1.0	0.9996	Very strong correlation.
Slope (vs. IL Test on ACL Futura)	Close to 1.0	0.9678	Strong agreement.
Correlation (r) (vs. IL Test on ACL Futura)	Close to 1.0	0.9943	Very strong correlation.
Within Run Precision	Not explicitly stated as acceptance criteria, but generally low CV% values are desirable.		The CV% values demonstrate good precision across various instruments and control levels. The ACL Advance shows slightly higher CV%s for both within-run and total precision compared to other instruments.
Normal Control Mean % Factor VII	Not explicitly stated, but expected to be around the nominal value.	79.4 - 100.5%	Values are within expected ranges for normal controls.
Normal Control Within Run CV%	Not explicitly stated, but low CV% is desirable.	0.8 - 4.7%	Generally low, with ACL Advance showing the highest (4.7%).
Normal Control Total CV%	Not explicitly stated, but low CV% is desirable.	1.9 - 5.7%	Generally low, with ACL Advance showing the highest (5.7%).
Low Abnormal Control Mean % Factor VII	Not explicitly stated.	37.8 - 50.9%	Values are within expected ranges for low abnormal controls.
Low Abnormal Control Within Run CV%	Not explicitly stated, but low CV% is desirable.	1.2 - 4.6%	Generally low, with ACL Advance showing the highest (4.6%).
Low Abnormal Control Total CV%	Not explicitly stated, but low CV% is desirable.	2.5 - 5.9%	Generally low, with ACL Advance showing the highest (5.9%).

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

Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal)
Sample Size for Precision: The text states "multiple runs (n=80)" using two levels of control. This means 80 measurements were taken for each control level on each instrument for the precision study.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective measurements of samples (either previously collected or prepared for the study), as opposed to prospective collection specifically for this study. The phrasing "evaluating 60 citrated plasma samples" and "using two levels of control" suggests existing or prepared samples within a laboratory setting.

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

This type of information is not applicable to this device and study. The device is for quantitative determination (measuring Factor VII activity), not for diagnostic interpretation by human experts. The "ground truth" for method comparison and precision studies typically relies on the established accuracy and precision of the predicate device and the known concentrations of control materials.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study, as there is no human interpretation or subjective assessment that would require adjudication.

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 information is not applicable. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging or interpretive tool. There are no human readers involved in the direct determination of Factor VII activity using this reagent.

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

This concept is not directly applicable in the same way it would be for an AI algorithm. However, the performance data presented (method comparison and precision) is essentially "standalone" in the sense that it measures the performance of the device (reagent and instrument system) independently, without human interpretive input affecting the quantitative result. The device itself performs the measurement.

7. The Type of Ground Truth Used

For Method Comparison: The measurements from the predicate devices (Hemoliance Factor VII Deficient Plasma and IL Test Factor VII Deficient Plasma) served as the comparative "ground truth" to establish substantial equivalence.
For Precision: The known, established concentrations or expected values of the control materials (Normal Control and Low Abnormal Control) served as the ground truth against which precision (variability) was assessed.

8. The Sample Size for the Training Set

This information is not applicable. This is an in vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The development of such reagents involves chemical and biological formulation and optimization, not data-driven model training.

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

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

Summary

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K024082

Section 3 HemosIL Factor VII 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 781-861-4207 Fax:

FEB 1 2 2003

Contact Person:

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

Summary Prepared:

December 10, 2002

Name of the Device:

HemosIL Factor VII Deficient Plasma

Classification Name(s):

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

Identification of Predicate Device(s):

Hemoliance Factor VII Deficient Plasma on ELECTRA Series Analyzers K893535 IL Test Factor VII Deficient Plasma* on ACL Family of Analyzers K002400 *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems, most recently the ACL Advance.

Description of the Device/Intended use(s):

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 VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.

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

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

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

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating 60 citrated plasma samples (30 normal/ 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VII Deficient Plasma versus the predicate devices are shown below:

NOTE: HemosIL RecombiPlasTin (K012768) was used as the PT reagent in all testing.

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

IL System	Slope	r
E1400C	0.9683	0.9967

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

IL System	Slope	r
ACL 300	1.0045	0.9994
ACL 6000	0.9646	0.9989
ACL 9000	0.9778	0.9996
ACL Futura	0.9678	0.9943

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 VII	Within runCV%	TotalCV%
ACL 300	Normal Control	99.6	1.0	2.9
	Low Abnormal Control	49.1	1.2	2.7
ACL 6000	Normal Control	100.5	1.4	1.9
	Low Abnormal Control	49.9	1.5	2.5
ACL 9000	Normal Control	99.4	0.8	2.7
	Low Abnormal Control	47.6	1.4	3.6
ACL Advance	Normal Control	99.9	4.7	5.7
	Low Abnormal Control	50.9	4.6	5.9
ELECTRA1400C	Normal Control	79.4	2.2	2.7
	Low Abnormal Control	37.8	2.4	3.4

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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 & Human Services. The logo features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines suggesting movement or connection. The overall design is simple and conveys a sense of unity and service.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 2 2003

Re: K024082 Trade/Device Name: HemosIL Factor VII Deficient Plasma Regulation Number: 21 CFR § 864,7290 Regulation Name: Plasma, Coagulation Factor Deficient Regulatory Class: II Product Code: GJT Dated: December 10, 2002 Received: December 11, 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 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 VII Deficient Plasma

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K024082
510(k) Number

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

HemosIL Factor VII 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).