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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HemosIL Factor V Deficient Plasma device:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of pre-defined thresholds for slope, correlation, or CV%. Instead, the implied acceptance criteria for substantial equivalence are based on demonstrating comparable performance to the predicate devices. The study data presented serves as the evidence that these implicit criteria (i.e., performance similar to predicate devices) are met.

Performance Metric	Implied Acceptance Criteria (Demonstrate equivalence to predicate)	Reported Device Performance (HemosIL Factor V Deficient Plasma)
Method Comparison vs. Hemoliance F-V Deficient Plasma (ELECTRA E1400C)	Slope and 'r' comparable to predicate	Slope: 1.0161, r: 0.9877
Method Comparison vs. IL Test F-V Deficient Plasma (ACL 300)	Slope and 'r' comparable to predicate	Slope: 1.0005, r: 0.9932
Method Comparison vs. IL Test F-V Deficient Plasma (ACL 6000)	Slope and 'r' comparable to predicate	Slope: 0.9771, r: 0.9940
Method Comparison vs. IL Test F-V Deficient Plasma (ACL 9000)	Slope and 'r' comparable to predicate	Slope: 0.9746, r: 0.9945
Method Comparison vs. IL Test F-V Deficient Plasma (ACL Futura)	Slope and 'r' comparable to predicate	Slope: 1.1331, r: 0.9814
Within Run Precision (ACL 300 - Normal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 110.6, Within run CV%: 1.0, Total CV%: 3.1
Within Run Precision (ACL 300 - Low Abnormal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 30.1, Within run CV%: 1.8, Total CV%: 3.5
Within Run Precision (ACL 6000 - Normal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 115.1, Within run CV%: 1.5, Total CV%: 3.0
Within Run Precision (ACL 6000 - Low Abnormal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 31.5, Within run CV%: 1.9, Total CV%: 2.8
Within Run Precision (ACL 9000 - Normal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 113.7, Within run CV%: 1.2, Total CV%: 1.7
Within Run Precision (ACL 9000 - Low Abnormal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 29.0, Within run CV%: 4.0, Total CV%: 5.6
Within Run Precision (ACL Advance - Normal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 132.4, Within run CV%: 6.0, Total CV%: 7.6
Within Run Precision (ACL Advance - Low Abnormal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 27.1, Within run CV%: 4.1, Total CV%: 5.7
Within Run Precision (ELECTRA 1400C - Normal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 101.0, Within run CV%: 2.1, Total CV%: 3.5
Within Run Precision (ELECTRA 1400C - Low Abnormal Control)	CV% comparable to expected diagnostic precision for this assay type	Mean % Factor V: 24.0, Within run CV%: 1.5, Total CV%: 2.6

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

Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal).
Sample Size for Precision: Controls run over multiple runs (n=80) for each instrument.
Data Provenance: The document does not specify the country of origin or whether the samples were retrospective or prospective. It only states "citrated plasma samples."

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

This device is an in vitro diagnostic reagent. The "ground truth" for Factor V activity would typically be established by the reference method (the predicate device, in this case) or a validated laboratory method using established controls.
The concept of "experts" in the sense of clinical reviewers (e.g., radiologists) and their qualifications is not applicable to this type of device and study. The ground truth is the measured laboratory value.

4. Adjudication method for the test set:

Not applicable. This is a comparison of quantitative laboratory measurements, not a qualitative assessment requiring 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:

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data. It's an in vitro diagnostic reagent.

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

This is a standalone diagnostic reagent. Its performance is evaluated intrinsically through comparison to predicate devices and precision studies, without human interpretation as part of the primary diagnostic result.

7. The type of ground truth used:

The ground truth for the method comparison study is implicitly the results obtained from the predicate devices (Hemoliance Factor V Deficient Plasma and IL Test Factor V Deficient Plasma) on their respective analyzer systems, using a common PT reagent (HemosIL RecombiPlasTin).
For the precision studies, the ground truth for the "normal" and "low abnormal" controls would be their assigned target values (or range) based on their manufacturing and calibration processes.

8. The sample size for the training set:

This device is a reagent and not a machine learning or AI model, so there is no "training set" in that context. The development of the reagent itself would involve formulation, characterization, and quality control, but not in the sense of a data-driven training set for an algorithm.

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

Not applicable, as there is no "training set" in the context of an algorithm.

Summary

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K023839

JAN 1 4 2003

Section 3 HemosIL Factor V 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 Manager Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

November 15, 2002

Name of the Device:

HemosIL Factor V Deficient Plasma

Classification Name(s):

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

Identification of Predicate Device(s):

K893533 Hemoliance Factor V Deficient Plasma on ELECTRA Series Analyzers
K002400 IL Test Factor V Deficient Plasma* on ACL Family of Analyzers
*NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems

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

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Section 3 HemosIL Factor V 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 V Deficient Plasma versus the predicate devices are shown below:

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

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

IL System	Slope	r
E1400C	1.0161	0.9877

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

IL System	Slope	r
ACL 300	1.0005	0.9932
ACL 6000	0.9771	0.9940
ACL 9000	0.9746	0.9945
ACL Futura	1.1331	0.9814

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 V	Within runCV%	TotalCV%
ACL 300	Normal Control	110.6	1.0	3.1
	Low Abnormal Control	30.1	1.8	3.5
ACL 6000	Normal Control	115.1	1.5	3.0
	Low Abnormal Control	31.5	1.9	2.8
ACL 9000	Normal Control	113.7	1.2	1.7
	Low Abnormal Control	29.0	4.0	5.6
ACL Advance	Normal Control	132.4	6.0	7.6
	Low Abnormal Control	27.1	4.1	5.7
ELECTRA1400C	Normal Control	101.0	2.1	3.5
	Low Abnormal Control	24.0	1.5	2.6

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2003

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

Re: K023839

Trade/Device Name: HemosIL Factor V Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency tests Regulatory Class: II Product Code: GJT Dated: November 15, 2002 Received: November 18, 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.

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Page 2

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.

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). Other general information on your responsibilities under the Act may be obtained 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 vours.

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): _ 50 93839

Device Name: HemosIL Factor V 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)

Josephine Bautista

(División Sigh-Off)

Division of Clinical Laboratory Devices K023839

510(k) Number

Prescription Use

OR Over-The-Counter Use

The-Counter Use

HemosIL Factor V 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).