HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.

AI/ML Overview

The provided text describes the 510(k) summary for the HemosIL Factor VIII Deficient Plasma device, which is an in vitro diagnostic intended for quantitative determination of factor VIII activity. The study presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical acceptance criteria in the way an AI/ML device would.

However, I can extract the performance data provided and frame it in a table, even if explicit "acceptance criteria" are not stated as pass/fail thresholds in the document. The study's aim was to show comparable performance to predicate devices.

1. A table of acceptance criteria and the reported device performance

For a diagnostic device like this, "acceptance criteria" are typically met by demonstrating performance (like correlation and precision) that is comparable to or better than a legally marketed predicate device. The document states that the device is "substantially equivalent... in performance, intended use and safety and effectiveness."

Performance Metric	Acceptance Criteria (Implicit for Substantial Equivalence to Predicate)	Reported Device Performance
Method Comparison vs. Hemoliance Factor VIII Deficient Plasma (ELECTRA System)	Similar slope and correlation coefficient to predicate	E1400C: Slope = 0.9518, r = 0.9873
Method Comparison vs. IL Test Factor VIII Deficient Plasma (ACL Family)	Similar slope and correlation coefficient to predicate	ACL 300: Slope = 0.9391, r = 0.9942 ACL Advance: Slope = 1.0073, r = 0.9906
Within-Run Precision (CV%)	Acceptable precision for clinical use (relative to predicate or industry standard)	ACL 9000: Normal Control (3.1%), Low Abnormal (2.2%) ACL Futura: Normal Control (2.7%), Low Abnormal (3.4%) ELECTRA 1600C: Normal Control (4.8%), Low Abnormal (4.1%)
Between-Run Precision (CV%)	Acceptable precision for clinical use (relative to predicate or industry standard)	ACL 9000: Normal Control (3.1%), Low Abnormal (3.3%) ACL Futura: Normal Control (3.6%), Low Abnormal (4.0%) ELECTRA 1600C: Normal Control (6.0%), Low Abnormal (4.6%)

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Method Comparison: Approximately 60 citrated plasma samples (30 normal and 30 abnormal) were used for each predicate comparison.
- Within-Run and Between-Run Precision: Not explicitly stated as a number of samples, but assessed over "multiple runs (n=80) on different instruments using a specific lot of APTT reagent and both normal and abnormal samples." This refers to the number of runs, not individual patient samples. Typically, controls are run multiple times.
Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of in vitro diagnostic device study does not typically involve human expert adjudication for ground truth in the same way an AI image analysis device would. The "ground truth" for method comparison is the result obtained from the predicate device (another established diagnostic test). For precision, the "ground truth" is the expected value of the control sample. Therefore, this section is not applicable.

4. Adjudication method for the test set

Not applicable. As noted above, this study compares the device's measurements to predicate device measurements or established control values, not to adjudicated expert opinions.

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

Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

Yes, this is a standalone device. The performance data presented (method comparison, precision) reflects the device's intrinsic analytical performance when run on the specified coagulation systems. It's a reagent that works with an instrument to produce a result, without direct human-in-the-loop interpretation of that result in the way an AI would assist.

7. The type of ground truth used

For Method Comparison: The "ground truth" was the results obtained from the predicate devices (Hemoliance Factor VIII Deficient Plasma and IL Test Factor VIII Deficient Plasma) on their respective analytical systems.
For Precision: The "ground truth" was the assigned values of normal and low abnormal control plasmas.

8. The sample size for the training set

Not applicable. This is a conventional in vitro diagnostic device, not an AI/ML device that requires a "training set" in that sense. The device's formulation and manufacturing processes are developed to achieve the intended performance characteristics.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of device.

Summary

{0}------------------------------------------------

Section 3 HemosIL Factor VIII 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:

Contact Person:

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

Summary Prepared:

December 23, 2003

Name of the Device:

HemosIL Factor VIII Deficient Plasma

Classification Name(s):

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

Identification of Predicate Device(s):

K893525 Hemoliance Factor VIII Deficient Plasma on ELECTRA Series Analyzers
K002400 IL Test Factor VIII 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);

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

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

{1}------------------------------------------------

Section 3 HemosIL Factor VIII 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 and 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VIII Deficient Plasma versus the predicate devices are shown below:

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

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

IL System	n	Slope	r
E1400C	59	0.9518	0.9873

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

IL System	n	Slope	r
ACL 300	60	0.9391	0.9942
ACL Advance	63	1.0073	0.9906

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 and SynthASil) and both normal and abnormal samples.

Instrument	Control	Mean% Factor VIII	Within runCV%	Between RunCV%
ACL 9000	Normal Control	72.6	3.1	3.1
ACL 9000	Low Abnormal Control	32.2	2.2	3.3
ACL Futura	Normal Control	78.3	2.7	3.6
ACL Futura	Low Abnormal Control	31.5	3.4	4.0
ELECTRA1600C	Normal Control	93.9	4.8	6.0
ELECTRA1600C	Low Abnormal Control	37.2	4.1	4.6

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Re:

FEB 1 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K034007 Trade/Device Name: HemosIL Factor VIII Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Plasma, Coagulation Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: December 23, 2003 Received: December 24, 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 I'DA 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.

{3}------------------------------------------------

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,

Joseph L. Arblett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): Kø 3 4007

Device Name: HemosIL Factor VIII 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
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)	K034007
Prescription Use		OR	Over-The-Counter Use

Section 2 HemosIL Factor VIII Deficient Plasma 510(k) Page 1 of 1

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).