IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. These tests are indicated for use with patients who have prolonged APTT test of undetermined origin.

This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

Device Description

IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IL Test™ LAC Screen and IL Test™ LAC Confirm (Extension onto the ACL Futura), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria. Instead, it demonstrates performance by comparing the device on the ACL Futura with its performance on an existing ACL 300 reference instrument and assessing precision. The reported performance suggests that the device operates comparably to the predicate device and within acceptable precision limits for diagnostic assays.

Performance Metric	Acceptance Criteria (Implied/Demonstrated)	Reported Device Performance
Correlation with Reference Instrument (ACL 300)	Strong correlation (r) to the predicate device on ACL 300.	r = 0.988 for normalized LAC ratio (comparing ACL Futura to ACL 300)
Within-run Precision (CV)	Acceptable Coefficient of Variation (CV) across multiple plasma levels.	- CV of 2.52% (at mean normalized ratio of 0.98) - CV of 6.32% (at mean ratio of 2.03) - CV of 2.36% (at mean normalized ratio of 1.51)

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

Sample Size: n = 53 for the correlation study. "3 levels of plasma" were used for the precision study, but the exact number of runs or individual samples within each run is not specified beyond "multiple runs."
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective, using plasma samples, but this is not definitively stated. There's no mention of a prospective study design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document describes performance studies for an in-vitro diagnostic product, not an imaging or interpretive device that would typically rely on expert human assessment for ground truth. Therefore, no experts were used to establish ground truth in the traditional sense for this type of device. The "ground truth" for this assay lies in the chemical and biological reactivity of the reagents and the accuracy of the instrument's measurement capabilities.

4. Adjudication Method for the Test Set

None specified. As this is a performance study for an in-vitro diagnostic assay rather than an interpretive clinical assessment, an adjudication method for a test set is not applicable. The measurements are objective numerical results from the instrument.

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

No. This is an in-vitro diagnostic product validation, not a study involving human readers interpreting results. Therefore, an MRMC study was not performed, and there's no data on the effect size of human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The entire study describes the performance of the device (IL Test™ LAC Screen and IL Test™ LAC Confirm on the ACL Futura analyzer) as a standalone system. The measurements of correlation and precision are direct evaluations of the algorithm/instrument system without human intervention in the measurement process itself.

7. Type of Ground Truth Used

Reference Instrument Comparison and Known Samples:
- For the correlation study, the "ground truth" was established by comparing results from the new device/instrument combination (ACL Futura) to a predicate/reference instrument (ACL 300) which is presumably already validated and considered accurate.
- For the precision study, "3 levels of plasma" were used. These would likely be characterized plasma samples with known or expected ranges of the analyte to assess the reproducibility of the measurements.

8. Sample Size for the Training Set

Not applicable / Not specified. This document describes the validation of an existing diagnostic reagent on a new instrument platform, not the development or training of a new algorithm (like an AI model). Therefore, there is no "training set" in the context of machine learning. The reagents and assay methodology would have been developed and validated previously.

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

Not applicable. As there is no training set for an AI/machine learning algorithm, this question is not relevant to the provided document. The development of the reagents and assay would have involved standard chemical and biological validation methods, which are not detailed here.

Summary

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4/8/99

K990302

Section 3

IL Test™ LAC Screen and IL Test™ LAC Confirm (Extension onto the ACL Futura) 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: (781) 861-4467 (781) 861-4464 Fax:

Contact Person:

Carol Marble Phone: (781) 861-4467

Summary Prepared:

January 29, 1999

Name of the device(s):

IL Test™ LAC Screen (extension of reagent onto the ACL Futura)

IL Test™ LAC Confirm (extension of reagent onto the ACL Futura)

Classification name(s):

864.8950 Russell Viper Venom Reagent

81GIR Reagent, Russell Viper Venom

Identification of predicate device(s):

K922156 LUPO-TEST II Reagent (included ACL Series performance data)

LUCOR Confirmatory Reagent (included ACL Series performance data) K922326

Description of the device/intended use(s):

IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The performance, intended use and safety and effectiveness of IL Test™ LAC Screen (LUPO-Test II) and IL Test™ LAC Confirm (Lucor Confirmatory Reagent) on the ACL Futura Coagulation System is substantially equivalent to that on the ACL Hundred/Thousand Series Coagulation System.

Summary of Performance Data:

In a comparison study of IL Test™ LAC Screen and IL Test™ LAC Confirm on an ACL 300 (reference instrument) versus an ACL Futura (test instrument), the correlation (r) of the normalized LAC ratio was 0.988 (n = 53).

On an ACL Futura, within run precision of IL Test™ LAC Screen and IL Test™ LAC Confirm assessed over multiple runs using 3 levels of plasma gave a CV of 2.52% (at a mean normalized ratio of 0.98), 6.32% (at a mean ratio of 2.03) and 2.36% (at a mean normalized ratio of 1.51).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 APR

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

Re: K990302

Trade Name: IL Test™ LAC Screen and IL Test™ LAC Confirm on ACL Futura Regulatory Class: II Product Code: GIR Dated: January 29, 1999 Received: February 1, 1999

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.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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):	K990302
---------------------------	---------

Device Names: IL Test™ LAC Screen and IL Test™ LAC Confirm (Extension of Reagents onto the ACL Futura)

Indications for Use:

)

This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Makin

(Division Sign-Off)
Division of Clinical Laboratory Devices K990302
510(k) Number.

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use

IL Test™ LAC Screen and LAC Confirm on ACL Futura 510(k) Section 2 Page 1 of 1

Regulation Number and Section

§ 864.8950 Russell viper venom reagent.

(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).