A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:

Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Device Description

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative determination in human citrated plasma of:

Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

AI/ML Overview

Here's an analysis of the provided text, extracting the requested information about device acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly defined by the "substantially equivalent" claim to predicate devices, particularly regarding performance metrics like slope and correlation coefficient (r) in method comparison studies, and Coefficient of Variation (CV) for precision. The reported device performance is directly given by the study results.

Study Type	Acceptance Criteria (Implicit)	Reported Device Performance (HemosIL RecombiPlasTin)
Method Comparison (Prothrombin Time)	Slope and 'r' values indicating substantial equivalence to Hemoliance® RecombiPlasTin. Ideal values would be a slope near 1 and an 'r' near 1.
ACL 9000	(Implicitly compared to predicate device K925604)	Slope: 0.90, r: 0.993
ACL Futura	(Implicitly compared to predicate device K925604)	Slope: 0.99, r: 0.995
E1400C	(Implicitly compared to predicate device K925604)	Slope: 0.95, r: 0.996
Method Comparison (Fibrinogen)	Slope and 'r' values indicating substantial equivalence to IL Test™ PT-Fibrinogen. Ideal values would be a slope near 1 and an 'r' near 1.
ACL 9000	(Implicitly compared to predicate device K862301)	Slope: 1.00, r: 0.933
ACL Futura	(Implicitly compared to predicate device K862301)	Slope: 1.10, r: 0.957
Within Run Precision (Prothrombin Time)	% CV values for control plasmas indicating acceptable precision. No explicit numerical threshold is given, but single-digit CVs are generally considered good.
ACL 9000	(Implicitly acceptable based on industry standards for diagnostic devices)	Level 1: 0.8% CV, Level II: 2.5% CV, Level III: 1.7% CV
ACL Futura	(Implicitly acceptable based on industry standards for diagnostic devices)	Level 1: 1.1% CV, Level II: 1.2% CV, Level III: 1.1% CV
E1400C	(Implicitly acceptable based on industry standards for diagnostic devices)	Level 1: 0.9% CV, Level II: 1.9% CV, Level III: 2.1% CV
Within Run Precision (Fibrinogen)	% CV values for control plasmas indicating acceptable precision. No explicit numerical threshold is given.
ACL 9000	(Implicitly acceptable based on industry standards for diagnostic devices)	Level 1: 4.3% CV, Low Fibrinogen: 3.6% CV
ACL Futura	(Implicitly acceptable based on industry standards for diagnostic devices)	Level 1: 4.5% CV, Low Fibrinogen: 9.8% CV

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

Sample Size:
- Method Comparison: 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples).
- Within Run Precision: Three levels of control plasmas for PT and two levels for Fibrinogen. The exact number of replicates for each level is not specified, but it's "over multiple runs."
Data Provenance: The document does not explicitly state the country of origin. It mentions "human citrated plasma." It is a retrospective study as it uses collected plasma samples.

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

This information is not provided in the document. The "ground truth" here is the measurement obtained from the predicate devices, not an expert consensus on a clinical outcome or image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves quantitative measurements against predicate devices, not an expert review or classification task that would require an adjudication method.

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

This information is not applicable. This device is a diagnostic reagent for in-vitro testing of blood components (Prothrombin Time and Fibrinogen), not an AI-powered image analysis or diagnostic aid for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance studies for the device (reagent) in conjunction with specified laboratory systems (ACL 3000, ACL Futura, ELECTRA 1400C). There is no "human-in-the-loop" component in the direct measurement of PT or Fibrinogen in this context.

7. The Type of Ground Truth Used

The ground truth used for the method comparison studies is the measurements obtained from the predicate devices:

K925604 Hemoliance® RecombiPlasTin for Prothrombin Time.
K862301 IL Test™ PT-Fibrinogen for Fibrinogen.

For the precision studies, the ground truth is implicitly the true value of the control plasmas, as determined by the manufacturer of those controls or accepted reference methods.

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" typically applies to machine learning algorithms. For a diagnostic reagent like HemosIL RecombiPlasTin, there isn't a "training set" in the same sense, as its performance relies on its chemical formulation and interaction with the analytical system, rather than being "trained" on data. The studies described are performance verification/validation studies.

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

This information is not applicable for the reasons stated in point 8.

Summary

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

Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4464

Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464

Summary Prepared:

August 16, 2001

Name of the Device:

HemosIL RecombiPlasTin

Classification Name(s):

864.7750	Prothrombin Time Test	Class II
81GJS	Test, Time, Prothrombin
864.7340	Fibrinogen Determination System	Class II
81GIS	Test, Fibrinogen

Identification of Predicate Device(s):

K925604 Hemoliance® RecombiPlasTin (PT Claims for IL Coagulation and ELECTRA Systems) K862301 IL Test™ PT-Fibrinogen (Fibrinogen Claims for IL Coagulation Systems Only)

Description of the Device/Intended Use(s):

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative determination in human citrated plasma of:

Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

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

HemosIL RecombiPlasTin is substantially equivalent to Hemoliance® RecombiPlasTin (for Prothrombin Time on IL Coagulation and ELECTRA Systems) and IL Test™ PT-Fibrinogen (for Fibrinogen on IL Coagulation Systems only) in performance, intended use and safety and effectiveness.

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

Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples) on an ACL 3000, ACL Futura and ELECTRA 1400C, the slopes and correlation coefficients (r) for HemosIL RecombiPlasTin versus the predicate devices are shown below:

Prothrombin Time (seconds) on IL Coagulation and ELECTRA Systems:

New Device vs. Predicate Device for PT: Hemoliance® RecombiPlasTin

IL System	Slope	r
ACL 9000	0.90	0.993
ACL Futura	0.99	0.995
E1400C	0.95	0.996

Fibrinogen (mg/dL) on IL Coagulation Systems Only:

New Device vs. Predicate Device for Fib: IL Test™ PT-Fibrinogen*

IL System	Slope	r
ACL 9000	1.00	0.933
ACL Futura	1.10	0.957

*NOTE: Values outside the linearity claim of 700 mg/dL were removed from calculations for a respective n=164 on the ACL 9000 and n=170 on the ACL Futura.

Within Run Precision

Within run precision assessed over multiple runs using three levels for Prothrombin Time and two levels for Fibrinogen of control plasmas gave the following results:

	PT (seconds)			Fibrinogen (mg/dL)
ACL 9000	Level 1	Level II	Level III	Level 1	Low Fibrinogen
Mean	11.8	28.8	57.1	303	127
% CV	0.8	2.5	1.7	4.3	3.6
ACL Futura	Level 1	Level II	Level III	Level 1	Low Fibrinogen
Mean	11.0	30.4	61.6	261	119
% CV	1.1	1.2	1.1	4.5	9.8
E1400C	Level 1	Level II	Level III
Mean	12.3	29.0	57.8
% CV	0.9	1.9	2.1

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

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 consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, curved design. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

SEP 1 8 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K012768 Re:

Trade Name: HemosIL RecombiPlasTin Regulation Number: 21 CFR § 864.7750 and 21 CFR § 864.7340 Regulatory Class: II Product Code: GJS, GGP, GIS Dated: August 16, 2001 Received: August 17, 2001

Dear Ms. Marble:

'We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K012768

Device Name: HemosIL RecombiPlasTin

Indications for Use:

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:

Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
Fibrinogen on IL Coagulation Systems only

The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

aboratory Devices

510(k) Number K012768

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use

Section 2

HemosIL RecombiPlasTin 510(k)

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).