HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. 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 IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX 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 IX Deficient Plasma device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific slope and correlation coefficient ranges. Instead, it implies that the device is acceptable if it demonstrates "substantial equivalence" to predicate devices through method comparison and satisfactory precision.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Demonstrate "substantial equivalence" to predicate devices via slope and correlation coefficient. Specifically, slopes ideally close to 1.0 and correlation coefficients ideally close to 1.0.	Vs. Hemoliance Factor IX Deficient Plasma (on ELECTRA IT Cast ci - E1600C):n=65, Slope = 1.0049, r = 0.9584Vs. IL Test Factor IX Deficient Plasma (on ACL Family - ACL 3000):n=76, Slope = 1.1076, r = 0.9793
Precision (Within-Run)	Acceptable reproducibility of results. (No specific quantitative criteria provided).	ACL 6000: Normal 5.8% CV, Low Abnormal 8.5% CVACL 9000: Normal 3.0% CV, Low Abnormal 2.3% CVACL Futura: Normal 4.4% CV, Low Abnormal 6.0% CVELECTRA 1400C: Normal 8.4% CV, Low Abnormal 8.0% CVELECTRA 1800C: Normal 8.8% CV, Low Abnormal 8.8% CV
Precision (Between-Run)	Acceptable reproducibility of results across different runs. (No specific quantitative criteria provided).	ACL 6000: Normal 2.6% CV, Low Abnormal 4.1% CVACL 9000: Normal 3.8% CV, Low Abnormal 5.9% CVACL Futura: Normal 2.9% CV, Low Abnormal 2.7% CVELECTRA 1400C: Normal 8.3% CV, Low Abnormal 7.6% CVELECTRA 1800C: Normal 5.7% CV, Low Abnormal 6.4% CV

Study Description:

The study to prove the device meets acceptance criteria involved two main parts: Method Comparison and Precision.

Method Comparison Study:

Sample size used for the test set:
- 65 citrated plasma samples for comparison against Hemoliance Factor IX Deficient Plasma on the E1600C.
- 76 citrated plasma samples for comparison against IL Test Factor IX Deficient Plasma on the ACL 3000.
Data provenance: Not explicitly stated, but "field site studies" suggest prospective collection. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study compares the new device's measurements against established predicate devices, which serve as the reference.
Adjudication method for the test set: Not applicable. Direct comparison of numerical results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an in-vitro diagnostic device measuring an analyte, not an imaging or diagnostic device requiring human interpretation of cases.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device's performance is measured in a standalone fashion, comparing its output to that of predicate devices. There is no "human-in-the-loop" component in the measurement itself.
The type of ground truth used: The results obtained from the predicate devices (Hemoliance Factor IX Deficient Plasma and IL Test Factor IX Deficient Plasma) served as the comparative 'ground truth' or reference for demonstrating substantial equivalence.
The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Precision Study (Within-Run and Between-Run):

Sample size used for the test set: "multiple runs (n=80)" for each instrument/control combination (40 measurements for Normal Control, 40 measurements for Low Abnormal Control on each of the 5 instruments listed, for a total of 80 measurements per instrument/control pair over the multiple runs).
Data provenance: Not explicitly stated, but implies laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Precision is about the device's own consistency.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone performance metric of the device's reproducibility.
The type of ground truth used: Not applicable. This study assesses the consistency of the device's measurements on control samples, rather than comparing to an independent ground truth. The "control" samples themselves have established target ranges, but the study measures the device's variability around the mean.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Ko3/829

Section 3 HemosIL Factor IX 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:

June 12, 2003

Name of the Device:

HemosIL Factor IX Deficient Plasma

Classification Name(s):

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

Identification of Predicate Device(s):

K893524 Hemoliance Factor IX Deficient Plasma on ELECTRA Series Analyzers K002400 IL Test Factor IX Deficient Plasma* on ACL Family of Analyzers *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 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 IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.

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

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

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Section 3

HemosIL Factor IX Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

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

NOTE: APTT-C and SynthASil were used as the APTT reagents in testing.

HemosIL Factor IX Deficient Plasma vs. Predicate Hemoliance Factor IX Deficient Plasma on ELECTRA IT Cast ci

IL System	n	Slope	r
E1600C	65	1.0049	0.9584

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

IL System	n	Slope	r
ACL 3000	76	1.1076	0.9793

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 (APTT-SP or SynthASil) and both normal and abnormal samples.

Instrument	Control	Mean% Factor IX	Within runCV%	Between RunCV%
ACL 6000	Normal Control	102.3	5.8	2.6
ACL 6000	Low Abnormal Control	24.2	8.5	4.1
ACL 9000	Normal Control	121.2	3.0	3.8
ACL 9000	Low Abnormal Control	32.8	2.3	5.9
ACL Futura	Normal Control	118.2	4.4	2.9
ACL Futura	Low Abnormal Control	38.2	6.0	2.7
ELECTRA1400C	Normal Control	111.5	8.4	8.3
ELECTRA1400C	Low Abnormal Control	28.9	8.0	7.6
ELECTRA1800C	Normal Control	119.2	8.8	5.7
ELECTRA1800C	Low Abnormal Control	30.2	8.8	6.4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Ms. Carol Marble Regulatory Affairs Manager JUL 3 1 2003 Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K031829

Trade/Device Name: HemosIL Factor IX Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT, GGP Dated: June 12, 2003 Received: June 13, 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. Iisting 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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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 (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 IX Deficient Plasma

Indications for Use:

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

Quitte y. Michane C m.D. FOR J. BAPTISTA

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ession Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Co

Over-The-Counter Use __

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).