IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

Device Description

IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IL Test™ APTT-SP device, based on the provided text:

Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Correlation (r)	Substantially equivalent to predicate IL Test™ APTT-C	ACL 300: 0.915 vs. predicate ACL Futura: 0.907 vs. predicate
Within-run Precision (CV)	Substantially equivalent to predicate IL Test™ APTT-C	ACL 300: 0.65% (mean 27.27s), 0.89% (mean 52.05s), 1.32% (mean 74.65s) ACL Futura: 0.65% (mean 27.50s), 0.84% (mean 50.89s), 0.93% (mean 72.38s)

Note: The text explicitly states that "IL Test™ APTT-SP...is substantially equivalent in performance, intended use, and safety and effectiveness" to the predicate device. Therefore, the acceptance criteria are implicitly defined by demonstrating this substantial equivalence through the reported performance metrics. No specific numerical thresholds for acceptance were provided in the document beyond achieving correlation and precision comparable to the predicate.

Study Details

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

Sample Size: 73 plasma samples (50 abnormal / 23 normal).
Data Provenance: Not explicitly stated, but clinical samples are generally used for this type of test. Whether it was retrospective or prospective is not mentioned. Given the context of a 510(k) summary, it's highly likely to be retrospective analysis of existing samples. The country of origin is not specified.

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. For in vitro diagnostic devices like APTT tests, the "ground truth" for the test set is typically established by the result from the predicate device (APTT-C in this case) or a reference method. It does not commonly involve human expert interpretation in the same way as, for example, image-based diagnostic AI.

4. Adjudication method for the test set:

This information is not applicable/provided. The study described is a method comparison study between the new device and a predicate device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment where consensus building is required, which is not the case for an automated diagnostic test like APTT.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI systems that assist human readers in tasks like medical image interpretation. The IL Test™ APTT-SP is an in vitro diagnostic assay, not an AI-assisted human reading device.

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

Yes, the performance reported is essentially a standalone performance. The IL Test™ APTT-SP is an automated diagnostic test run on coagulation systems (ACL 300 and ACL Futura). The reported correlation and precision values reflect the stand-alone performance of the device itself (reagent + instrument) in measuring APTT, without human interpretation influencing the result.

7. The type of ground truth used:

Predicate device results: The ground truth for this method comparison study was established by the results obtained from the predicate device, IL Test™ APTT-C. The new device's performance was evaluated against the measurements of the established predicate.

8. The sample size for the training set:

The document does not mention a training set. This type of 510(k) submission for a diagnostic assay typically focuses on validation data (the "test set" described), demonstrating equivalence to a predicate device. It's unlikely that a "training set" in the context of machine learning (where this term is often used) was part of this study for a traditional in vitro diagnostic reagent.

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

Not applicable, as a training set is not mentioned/relevant in the context of this traditional diagnostic assay validation.

Summary

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K973306

SECTION 3 IL Test™ APTT-SP - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

NOV - 4 1997

Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4467 (617) 861-4464 Fax:

Contact Persons:

Carol Marble Phone: (617) 861-4467 Alternate: Betty Lane Phone: (617) 861-4182

Summary Prepared:

September 2, 1997

Name of the device:

IL Test™ APTT-SP

Classification name(s):

864.7925	Partial Thromboplastin Time Tests
81 GFO	Activated Partial Thromboplastin

Identification of predicate device(s):

IL Test™ APTT-C

K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer

Class II

Description of the device/intended use(s):

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

IL Test™ APTT-SP uses the same test principle as the predicate IL Test™ APTT-C and is substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

In a method comparison study evaluating 73 plasma samples (50 abnormal/23 normal), the correlation (r) of the new IL Test™ APTT-SP to the predicate IL Test™ APTT-C on the ACL 300 was 0.915 and on the ACL Futura was 0.907. On the ACL 300, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.27 seconds), 0.89% (at a mean of 52.05 seconds) and 1.32% (at a mean of 74.65 seconds). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.50 seconds), 0.84% (at a mean of 50.89 seconds) and 0.93% (at a mean of 72.38 seconds).

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Requlatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

NOV - 4 1997

K973306 Re: IL Test™ APTT-SP Trade Name: Requlatory Class: II Product Code: GFO Dated: September 2, 1997 September 3, 1997 Received:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IL Test™ APTT-SP

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)
Division of Clinical Laboratory Services
510(k) Number	K973360

Prescription Use (Per 21 CFR 801.019)
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OR Over-The-Counter Use

Section 2	IL Test™ APTT-SP 510(k)	Page 1 of 1
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Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).