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

Device Description

Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in Factor XI. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor XI in the patient plasma, interpolated from a calibration curve.

AI/ML Overview

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Acceptance Criteria and Device Performance Study for HemosIL Factor XI Deficient Plasma

The HemosIL Factor XI Deficient Plasma is intended for the in vitro quantitative determination of Factor XI activity in citrated plasma. The acceptance criteria for this device are established through method comparison with predicate devices and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly derived from the performance of the predicate devices. For quantitative assays like this, key performance indicators are correlation (r) and agreement in slope for method comparison, and reproducibility (CV%) for precision.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance (HemosIL Factor XI Deficient Plasma)
Method Comparison
vs. Hemoliance F-XI Def Plasma (ELECTRA 1400C)	High correlation (r ≥ 0.95), Slope ≈ 1.0	Slope: 1.0063, r: 0.9808
vs. IL Test F-XI D Plasma (ACL 300)	High correlation (r ≥ 0.95), Slope ≈ 1.0	Slope: 0.9605, r: 0.9886
vs. IL Test F-XI D Plasma (ACL 6000)	High correlation (r ≥ 0.95), Slope ≈ 1.0	Slope: 1.0093, r: 0.9669
vs. IL Test F-XI D Plasma (ACL 9000)	High correlation (r ≥ 0.95), Slope ≈ 1.0	Slope: 0.9512, r: 0.9857
vs. IL Test F-XI D Plasma (ACL Futura)	High correlation (r ≥ 0.95), Slope ≈ 1.0	Slope: 0.9924, r: 0.9722
Within Run Precision (CV%)
Normal Control (ACL 300)	Expected low CV%	4.5%
Low Abnormal Control (ACL 300)	Expected low CV%	4.0%
Normal Control (ACL 6000)	Expected low CV%	3.5%
Low Abnormal Control (ACL 6000)	Expected low CV%	5.4%
Normal Control (ACL 9000)	Expected low CV%	4.5%
Low Abnormal Control (ACL 9000)	Expected low CV%	4.8%
Normal Control (ACL Advance)	Expected low CV%	4.6%
Low Abnormal Control (ACL Advance)	Expected low CV%	4.6%
Normal Control (ELECTRA 1400C)	Expected low CV%	2.4%
Low Abnormal Control (ELECTRA 1400C)	Expected low CV%	2.9%
Between Run Precision (CV%)
Normal Control (ACL 300)	Expected low CV%	4.4%
Low Abnormal Control (ACL 300)	Expected low CV%	5.6%
Normal Control (ACL 6000)	Expected low CV%	4.7%
Low Abnormal Control (ACL 6000)	Expected low CV%	7.4%
Normal Control (ACL 9000)	Expected low CV%	9.7%
Low Abnormal Control (ACL 9000)	Expected low CV%	7.5%
Normal Control (ACL Advance)	Expected low CV%	7.5%
Low Abnormal Control (ACL Advance)	Expected low CV%	5.5%
Normal Control (ELECTRA 1400C)	Expected low CV%	6.8%
Low Abnormal Control (ELECTRA 1400C)	Expected low CV%	6.6%

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

Sample Size for Test Set: Approximately 60 citrated plasma samples (30 normal / 30 abnormal) were used for the method comparison studies. For precision studies, specific numbers of runs (n=80) were performed, but the number of unique samples is not explicitly stated beyond "normal and abnormal samples".
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

N/A. This is a quantitative assay comparing against established predicate devices, not an interpretive diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the test set is the result obtained from the predicate devices.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically employed for subjective evaluations or when establishing ground truth from multiple human readers. This study involves objective quantitative measurements and comparisons to predicate device results.

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

N/A. This is a laboratory diagnostic device, not an imaging or clinical decision support AI tool that would typically involve a multi-reader multi-case comparative effectiveness study to assess human reader improvement with AI assistance. The device operates in a standalone capacity to quantify Factor XI activity.

6. Standalone Performance Study

Yes, a standalone performance study was done. The precision studies (within-run and between-run variability) demonstrate the device's performance characteristics independently of comparison to another device, assessing its inherent reproducibility. The method comparison also implicitly evaluates the standalone performance by showing its agreement with predicate devices whose performance is already established.

7. Type of Ground Truth Used

The ground truth used for the method comparison studies was the results obtained from the legally marketed predicate devices: Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers and IL Test Factor XI Deficient Plasma on ACL Family of Analyzers. For precision, the ground truth is the expected performance (e.g., target values for controls) and statistical measures of variability.

8. Sample Size for the Training Set

N/A. This device is a reagent and an assay system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical and biological principles and optimization, rather than machine learning on a dataset.

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

N/A. As stated above, this is not an AI/ML device requiring a training set and associated ground truth establishment.

Summary

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Section 3 HemosIL Factor XI 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:

January 27, 2003

Name of the Device:

HemosIL Factor XI Deficient Plasma

Classification Name(s):

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

Identification of Predicate Device(s):

Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers K893536

IL Test Factor XI 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):

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

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

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

Summary of Performance Data:

Method Comparison

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

NOTE: IL Test APTT-SP and SynthASil were used as the APTT reagents in all testing.

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

IL System	Slope	r
E1400C	1.0063	0.9808

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

IL System	Slope	r
ACL 300	0.9605	0.9886
ACL 6000	1.0093	0.9669
ACL 9000	0.9512	0.9857
ACL Futura	0.9924	0.9722

Within Run Precision

Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of APTT reagent (SynthASil on ELECTRA and APTT-SP on IL Coagulation Systems) and both normal and abnormal samples.

Instrument	Control	Mean% Factor XI	Within runCV%	Between RunCV%
ACL 300	Normal Control	81.0	4.5	4.4
ACL 300	Low Abnormal Control	41.1	4.0	5.6
ACL 6000	Normal Control	77.1	3.5	4.7
ACL 6000	Low Abnormal Control	40.9	5.4	7.4
ACL 9000	Normal Control	100.5	4.5	9.7
ACL 9000	Low Abnormal Control	49.8	4.8	7.5
ACL Advance	Normal Control	97.9	4.6	7.5
ACL Advance	Low Abnormal Control	54.2	4.6	5.5
ELECTRA1400C	Normal Control	136.7	2.4	6.8
ELECTRA1400C	Low Abnormal Control	71.7	2.9	6.6

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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 the department's symbol, which is a stylized caduceus with three intertwined snakes forming a human profile. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2003

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

Re: K030287 Trade/Device Name: HemosIL Factor XI Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: January 24, 2003 Received: January 28, 2003

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): K030387

Device Name: HemosIL Factor XI Deficient Plasma

Indications for Use:

HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of factor XI and intended for the in vitro diagnostic quantitative determination of factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) 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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K030287

Prescription Use	✓	OR	Over-The-Counter Use
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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).