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

AI/ML Overview

The provided 510(k) summary for the HemosIL Factor II Deficient Plasma does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device had to meet. Instead, the study demonstrates that the new device is "substantially equivalent" to predicate devices by showing comparable performance.

However, we can infer performance metrics that were deemed acceptable for substantial equivalence based on the presented data. The study primarily relies on method comparison and precision data.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" are not given. The study aims to demonstrate substantial equivalence to predicate devices. We can infer that correlation coefficients (r) close to 1.0, slopes close to 1.0, and small intercepts compared to predicate devices, along with acceptable precision (%CV), were considered evidence of substantial equivalence.

Performance Metric	Implied "Acceptance Range" (for substantial equivalence)	Reported Device Performance (Range Across Systems)
Method Comparison (vs. Predicate/Reference Device)
Correlation Coefficient (r)	Close to 1.0 (e.g., typically > 0.95 or 0.98 for strong correlation in equivalent devices)	0.9855 to 0.9954
Slope	Close to 1.0 (e.g., typically 0.95-1.05)	1.0357 to 1.0603
Intercept	Close to 0 (e.g., often within a small clinically acceptable range)	-4.6831 to 1.0196
Within Run Precision (%CV)	Typically a low percentage, e.g., < 5% or < 10% depending on analyte and clinical context.	2.3% to 6.2%
Between Run Precision (%CV)	Typically a low percentage, e.g., < 5% or < 10% depending on analyte and clinical context.	2.0% to 6.4%

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

Sample Size (Method Comparison): Approximately 60 citrated plasma samples for the in-house method comparison study. A separate clinical study used n=61 samples.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Massachusetts, USA. The studies are described as "in-house" and "clinical," suggesting they were conducted by the manufacturer or collaborators, likely within the US, but this is not definitively stated.
- Retrospective or Prospective: Not explicitly stated. The description "evaluating approximately 60 citrated plasma samples" and "clinical study" doesn't specify the collection method. However, for method comparison, samples are often either prospectively collected or selected from an existing bank that represents the intended use population.

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

Ground Truth Establishment: For in-vitro diagnostic (IVD) devices like this, "ground truth" for method comparison and precision is established by the reference method (the predicate device) and by validated control materials, rather than by human expert consensus or pathology review.
Number and Qualifications of Experts: Not applicable in the traditional sense for this type of IVD performance study. The "truth" is based on the performance of a legally marketed predicate device and well-characterized control materials.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is a quantitative IVD method comparison study where results are numerical and compared against a reference method, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging where human readers interpret results. The HemosIL Factor II Deficient Plasma is an in-vitro diagnostic reagent designed for automated analyzers.

6. If a Standalone Study Was Done

Standalone Study: Yes, the performance data presented is for the algorithm/device (HemosIL Factor II Deficient Plasma) operating on various IL Coagulation and ELECTRA systems. The "method comparison" directly compares the new device's performance against legally marketed predicate devices, demonstrating its standalone functionality in achieving comparable results. The precision studies also show its standalone performance.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for assessment of the new device is based on the performance of the legally marketed predicate devices (Hemoliance Factor II Deficient Plasma and HemosIL Factor II Deficient Plasma predicate versions) and using known normal and abnormal control materials.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not describe a "training set" in the context of machine learning or AI models. This device is a diagnostic reagent, and its development typically involves formulation optimization and analytical verification rather than algorithmic training on a dataset. Therefore, this concept is not directly applicable.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this IVD device. The development of such a reagent involves analytical chemistry, reagent formulation, and stability studies, rather than training on a data set with an established ground truth.

Summary

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i< 050661

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

Submitted by:

Instrumentation Laboratory Co. 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:

March 14, 2005

Name of the Device:

HemosIL Factor II Deficient Plasma

Regulatory Information:

Regulation Section:	Factor Deficiency Test (864.7290)
Classification:	Class II
Product Code:	GJT
Panel:	Hematology

Identification of Predicate Device(s):

K900133	Hemoliance Factor II Deficient Plasma on ELECTRA Series Analyzers
K002400	HemosIL Factor II Deficient Plasma* on ACL Family of Analyzers
	*NOTE: FDA cleared as part of each ACL instrument 510(k): for
	example, the ACL Advance (K002400)

Description of the Device/Intended Use(s):

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

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

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

Summary of Performance Data:

Method Comparison

In an in-house method comparison study evaluating approximately 60 citrated plasma samples, the correlation statistics for HemosIL Factor II Deficient Plasma versus the predicate devices are shown below:

System	slope	intercept	r	Reference method
ACL 300	1.0357	1.0196	0.9921	HemosIL Factor II Deficient Plasma
ACL 6000	1.0464	-2.1396	0.9954	HemosIL Factor II Deficient Plasma
ACL 9000	1.0458	-1.6123	0.9953	HemosIL Factor II Deficient Plasma
ACL TOP	1.0582	-4.6831	0.9855	HemosIL Factor II Deficient Plasma
E1600C	1.0603	-0.2821	0.9917	Hemoliance Factor II Deficient Plasma

NOTE: HemosIL RecombiPlasTin was used as the PT reagent in testing.

In a separate clinical study (n=61), the following correlation statistics were obtained on an ACL Futura using a specific lot of PT reagent (RecombiPlasTin):

System	slope	intercept	r	Reference method
ACL Futura	1.0602	-3.6113	0.9946	HemosIL Factor II Deficient Plasma

Within Run Precision

Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of PT reagent (RecombiPlasTin) and both normal and abnormal controls.

Instrument	Control	Mean% Factor II	Within run%CV	Between Run%CV
ACL 9000	Normal Control	99.2	2.5	2.0
	Special Test Control Level 2	33.8	2.5	4.5
ACL Futura	Normal Control	86.8	3.9	4.7
	Special Test Control Level 2	25.9	6.2	3.1
ACL TOP	Normal Control	130.6	2.8	4.3
	Special Test Control Level 2	28.6	3.3	4.8
ELECTRA	Normal Control	99.4	2.3	5.1
1600C	Special Test Control Level 2	33.3	2.8	6.4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is 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 image of an eagle with three stripes representing its wings.

MAY - 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

Re: K050661

Trade/Device Name: HemosIL Factor II Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT ﺒﻲ Dated: March 14, 2005 Received: March 15, 2005

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 r read be act not a latermination 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 OFF Part 820), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements us o 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 (240) 276-0484. 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 Four may other games games garrers, 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/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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): Kp5066/

Device Name: HemosIL Factor II Deficient Plasma

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Josephine Bautista
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050661

HemosIL Factor II 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).