IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

Device Description

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Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for IL Test™ PT-Fibrinogen Recombinant

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "slope must be between X and Y," or "r-value must be greater than Z"). Instead, it presents the results of method comparison and precision studies and implies that these results demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that led to the 510(k) clearance by the FDA, signifying that the performance was deemed acceptable for market release.

Test Parameter	Device	Reported Performance (Slope)	Reported Performance (r)	Inferred Acceptance (Context: Substantial Equivalence to Predicate)
PT (seconds) - ACL 3000	IL Test™ PT-Fibrinogen Recombinant	1.04	0.918	Near 1.0 (slope) and high correlation (r) to predicate
PT (seconds) - ACL Futura	IL Test™ PT-Fibrinogen Recombinant	1.09	0.949	Near 1.0 (slope) and high correlation (r) to predicate
Fibrinogen (mg/dL) - ACL 3000	IL Test™ PT-Fibrinogen Recombinant	0.93	0.977	Near 1.0 (slope) and high correlation (r) to predicate
Fibrinogen (mg/dL) - ACL Futura	IL Test™ PT-Fibrinogen Recombinant	1.05	0.982	Near 1.0 (slope) and high correlation (r) to predicate

Test Parameter	Device	Reported Performance (Mean)	Reported Performance (% CV)	Inferred Acceptance (Context: Acceptable Precision)
PT (seconds) - ACL 3000 (Normal)	IL Test™ PT-Fibrinogen Recombinant	10.97	0.53	Low % CV for good precision
PT (seconds) - ACL 3000 (Abnormal)	IL Test™ PT-Fibrinogen Recombinant	24.52	1.20	Low % CV for good precision
Fibrinogen (mg/dL) - ACL 3000 (Normal)	IL Test™ PT-Fibrinogen Recombinant	216.04	4.25	Acceptable % CV for fibrinogen measurement
Fibrinogen (mg/dL) - ACL 3000 (Abnormal)	IL Test™ PT-Fibrinogen Recombinant	116.30	4.36	Acceptable % CV for fibrinogen measurement
PT (seconds) - ACL Futura (Normal)	IL Test™ PT-Fibrinogen Recombinant	11.98	1.37	Low % CV for good precision
PT (seconds) - ACL Futura (Abnormal)	IL Test™ PT-Fibrinogen Recombinant	27.69	1.99	Low % CV for good precision
Fibrinogen (mg/dL) - ACL Futura (Normal)	IL Test™ PT-Fibrinogen Recombinant	261.55	5.03	Acceptable % CV for fibrinogen measurement
Fibrinogen (mg/dL) - ACL Futura (Abnormal)	IL Test™ PT-Fibrinogen Recombinant	106.11	2.90	Acceptable % CV for fibrinogen measurement

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

Sample Size for Method Comparison: n=79 (normal and abnormal plasma samples).
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of laboratory method comparison and precision studies, they are typically conducted prospectively with specifically collected or procured samples for the purpose of the study.

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

This type of diagnostic device (in vitro diagnostic for PT and Fibrinogen) does not typically involve human experts establishing a "ground truth" in the same way an imaging or AI diagnostic algorithm might. In this context, the "ground truth" for the method comparison study is the measurement provided by the predicate device (IL Test™ PT-Fibrinogen HS Plus). The document does not mention the involvement of any human experts for this purpose.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is the predicate device's measurement. There is no mention of human adjudication for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an in vitro diagnostic reagent and system for laboratory testing, not an AI or imaging diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, a standalone performance study was done. The "device" in this context refers to the reagent and the analytical system (ACL 3000, ACL Futura). The provided data represents the performance of the system (reagent + analyzer) in measuring PT and Fibrinogen, without direct human intervention in the result generation itself, beyond performing the test according to standard lab procedures. The results (slopes, correlation coefficients, precision) are quantitative measures of the device's analytical performance.

7. Type of Ground Truth Used

For the method comparison studies, the "ground truth" was established by the predicate device (IL Test™ PT-Fibrinogen HS Plus). The performance of the new device was compared against the measurements obtained from the legally marketed predicate device.

For the precision studies, the "ground truth" is the statistically derived mean value of the repeated measurements for normal and abnormal samples, against which the variability (% CV) is assessed.

8. Sample Size for the Training Set

The document does not mention a "training set." This terminology is primarily relevant for machine learning or AI models. This submission is for an in vitro diagnostic reagent, which does not involve a machine learning model that requires a separate training set. The samples used are for performance validation (method comparison and precision).

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

Not applicable, as there is no training set for this type of medical device submission.

Summary

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JUL - 7 1998

Section 3 IL Test™ PT-Fibrinogen Recombinant - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:

Contact Person:

Carol Marble Phone: (781) 861-4467

Summary Prepared:

April 23, 1998

Name of the Device:

IL Test™ PT-Fibrinogen Recombinant

Classification Name(s):

864.7340	Fibrinogen determination system	Class II
864.7750	Prothrombin time test	Class II
81GIS	Test, fibrinogen
81GIS	Test, time, prothrombin

Identification of Predicate Device(s):

IL Test™ PT-Fibrinogen HS Plus K933252/S

Description of the Device/Intended use(s):

Statement of how the Technological Characteristics of the Device compare to the Predicate device:

IL Test™ PT-Fibrinogen Recombinant has the same test principle as the predicate IL Test™ PT-Fibrinogen HS Plus and is substantially equivalent in performance, intended use and safety and effectiveness.

IL Test™ PT-Fibrinogen Recombinant 510(k)

169814799

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Section 3 IL Test™ PT-Fibrinogen Recombinant - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

In method comparison studies evaluating normal and abnormal plasma samples (n=79) on an ACL 3000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ PT-Fibrinogen Recombinant versus the predicate device are shown below:

System	PT (seconds)		Fibrinogen (mg/dL)
	Slope	r	Slope	r
ACL 3000	1.04	0.918	0.93	0.977
ACL Futura	1.09	0.949	1.05	0.982

Within run precision assessed over multiple runs using both normal and abnormal samples gave the following results:

		PT (seconds)	Fibrinogen (mg/dL)
ACL 3000		Normal	Abnormal	Normal	Abnormal
	Mean	10.97	24.52	216.04	116.30
	% CV	0.53	1.20	4.25	4.36
ACL Futura		PT (seconds)	Normal	Abnormal	Fibrinogen (mg/dL)	Normal	Abnormal
		Normal	Abnormal	Normal	Abnormal
	Mean	11.98	27.69	261.55	106.11
	% CV	1.37	1.99	5.03	2.90

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 1998 JUL

Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

Re: K981479 IL Test PT-Fibrinogen Recombinant Regulatory Class: II Product Code: GJS, GIS Dated: April 23, 1998 Received: April 24, 1998

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ದಿ 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 In addition, FDA may publish further announcements action. 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 requlations.

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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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

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

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Indications for Use Statement

81479 510(k) Number (if known):

Device Name: IL Test™ PT-Fibrinogen Recombinant

Indications for Use:

This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number _4981479

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use _

IL Test™ PT-Fibrinogen Recombinant 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).